cyrilzakka/clinical-trials huggingface dataset:
Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease

STA-5326 is an experimental drug that has been shown to block the release of interleukin-12 from peripheral blood mononuclear cells. Given this activity on the immune system, STA-5326 mesylate is a potential treatment for various autoimmune diseases, such as Crohn's disease, that are mediated by the inappropriate expression of Th1 cytokines.

This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe, active Crohn's disease. Study visits include a screening visit, 9 treatment period visits over 6 months and a follow-up visit that will occur 30 days following the end of treatment. Study drug treatment will continue for up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Is male or female aged 18 through 75 years.
* Has Crohn's disease diagnosed definitively prior to Screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments).
* Has a Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive at Baseline.

Exclusion Criteria:

* Has any clinically significant disease (eg, renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this study.
* Is a woman who has a positive pregnancy test, who is breast-feeding, or who is sexually active without using birth control during the course of the study and Follow-Up period.
* Is a woman of childbearing potential or a man who does not agree to use 2 forms of contraception during the course of the study and Follow-Up period.
* Has clinically significant hematologic, hepatic or renal laboratory abnormalities.
Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance

This multicenter retrospective study assessed the efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after several lines of TKIs' resistance.

The short-lived duration of disease control and secondary drug resistance have posed a threat to the effect of TKIs. Fruquintinib is a novel TKI with a high selectivity of VEGFR-1,2,3 without metabolism by liver enzymes and was approved for application in mCRC. Serious drug resistance and the unique characteristics of fruquintinib have prompted us to verify whether this drug can reverse TKIs' resistance at a higher dose.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed bone or soft tissue sarcomas;
2. Progressed after several lines of therapy;
3. Previously treated with other TKIs before fruquintinib;
4. Received fruquintinib-based treatment;
5. Measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST) version1.1;
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤3

Exclusion Criteria:

1. Failure to complete regular follow-up after administration.
2. Discontinued the fruquintinib-based treatment due to neither progression nor unacceptable toxicity.
U/S Guided SAPB Versus Conventional IV Analgesics in Postoperative Pain Management in MRM

The aim of this study is to compare the effect of ultra-sound guided serratus anterior plane block versus conventional IV analgesics in postoperative pain management in modified radical mastectomy (MRM)

All patients undergoing modified radical mastectomy were assigned to one of the following two groups:Group A: Serratus anterior plane block group (SAPB group): this group consists of 20 patients who received ultra sound guided serratus anterior plane block just after induction of anesthesia and Group B: IV analgesics group (control group): this group consists of 20 patients who did not receive any type of block.Further evaluations were carried out by a different investigator who was unaware of the patients' grouping. The degree of post-operative pain was assessed at: just upon arrival to the PACU, 2, 4, 8, 12 and 24 hours using the VAS score and the haemodynamic data and respiratory rate were measured during the first 24 hours after the end of the surgery. Postoperative analgesia regimen was standard in both groups; patients from each groups received 1 gm of Paracetamol Q 8 hours.

Patients reporting VAS ( visual analogue score) score greater than 40, mean arterial blood pressure, heart rate or respiratory rate \>20% from the baseline, were given Pethidine (50 mg IV) as rescue analgesic. While, those reporting VAS score less than 40 with mean arterial blood pressure, heart rate or respiratory rate \>20% from the baseline but still complaining; Ketoralac (30 mg IV) was given with a maximum dose of 120 mg/ day.

Eligibility Criteria:
Inclusion Criteria:

* Females aged between 20-60 years old.
* Preoperative physical status: ASA (American Society of Anesthesiology) I \& II.
* Body mass index (BMI) \< 35 Kg/ m2.
* Candidate for unilateral modified radical mastectomy.
* Informed consent to participate in the study.

Exclusion Criteria:

* - Females aged \< 20 years old or \> 60 years old.
* Preoperative physical status: ASA III \& IV.
* Morbid obese patients with BMI \> 35 Kg/ m2.
* Refusal to participate in the study.
* Addiction to narcotics or psycho-active drugs.
* Psychological disorders.
* Contra-indications to regional anesthesia (coagulopathy, injection site infection or allergy to any of the study drugs)
Aripiprazole Treatment of the Prodrome

The RAP Program is conducting a research study of the antipsychotic medication Aripiprazole. This drug has been approved for treating symptoms associated with schizophrenia and is associated with fewer side effects. This study will explore how well Aripiprazole treats symptoms of early-onset psychotic disorders as well as symptoms that may indicate risk for such disorders, including unusual thoughts, suspiciousness, perceptual abnormalities, social isolation, and sudden changes in functioning.

During the 12-week study, eligible patients are seen 7-9 times by research raters and psychiatrists. These visits include side effect monitoring, scheduled medication increases, and ratings designed to measure subtle improvement of symptoms. Monthly blood and urine samples are collected for safety and substance abuse monitoring, and neuropsychological testing is conducted at the first and last appointments. Participants are compensated for their participation and receive medication and study-related visits at no cost during the trial. Depending on their level of response to the medication, participants may also be eligible for a 3-month extension phase.

Eligibility Criteria:
Inclusion Criteria:

* You are between the ages of 13 and 22.
* You are English-speaking.
* You have a diagnosed psychotic disorder, including: schizophrenia, schizophreniform disorder, schizoaffective disorder, or other psychotic disorder
* OR -
* You are experiencing one or more pre-psychotic symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
* You meet additional RAP criteria assessed during screening and interview.

Exclusion Criteria:

* You have a diagnosis of bipolar disorder or major depression with psychotic features.
* You have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
* You have past or current substance dependence.
* You are currently taking Aripiprazole.
* You have taken Aripiprazole in the past.
* You are currently taking and responding well to another medication.
Estrogen Receptor-Positive Breast Cancer Patient-Derived Xenografts

The investigators will establish a platform at Dartmouth-Hitchcock Medical Center to generate novel models of estrogen receptor alpha-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, which will be used for research studies to develop novel treatment strategies and dissect signaling pathways underlying drug sensitivity and resistance.


Eligibility Criteria:
Inclusion criteria

1. Men and women \> age 18 with histologically documented ER+/HER2- breast cancer or with a history of ER+/HER2- breast cancer, for whom a tumor biopsy or surgical resection is clinically indicated and will be performed as standard of care.

   Tumor specimens may be from breast (progressive or recurrent) or metastatic sites. Patients with multicentric or bilateral disease are eligible.
2. Patients must have disease progression during neoadjuvant therapy, recurrence after neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic disease.
3. ER positivity is defined as \>10% of malignant tumor cells staining positively for ER by immunohistochemistry (IHC).

   HER2 negativity is defined as IHC 0-1+, or with a fluorescence in situ hybridization (FISH) ratio of \<1.8 if IHC is 2+ or if IHC has not been done.
4. Excess LIVE tumor tissue must be available from the surgically resected tumor specimen, or from 1-3 extra core needle or incisional biopsy. LIVE tumor tissue must be available within 2 hours of removal from patient (shorter time is preferable).
5. A recurrent or progressing breast cancer must be greater than 1 cm in greatest diameter.
6. Prior therapy is allowed as long as excess viable tumor tissue is available from the biopsy or surgical excision procedure.
7. Patients must be willing to provide 6 mL of blood, which can be obtained during a routine clinically indicated blood draw (ideally, done on the same day as the tumor biopsy/surgery).
8. Ability to give signed informed consent.

Exclusion Criteria

1. Fine needle aspirates and effusions of bodily fluids are not eligible as sources of tumor cells.
Management and Thermal Comfort of Premature Infants Under 32 Weeks

Sleep propensity was assessed in terms of the duration of a spontaneous episode of wakefulness (W). Skin temperatures at six body sites (the abdomen, pectoral region, eye, hand, thigh and foot) were measured (using infrared thermography) during nocturnal polysomnography in 29 9-day-old preterm neonates (postmenstrual age: 209 9 days). Te investigators then determined whether the duration of the W episode depended upon the local skin temperatures measured at the start, during and end of the episode.

Although sleep is of paramount importance for preterm neonates, care of the latter in a neonatal intensive care unit does not favour sleep. Given that several studies in adults have described a 'vegetative preparedness to sleep' (in which distal skin vasodilation before lights-out promotes rapid sleep onset), the investigators looked at whether or not this process operates in preterm neonates. Sleep propensity was assessed in terms of the duration of a spontaneous episode of wakefulness (W). Skin temperatures at six body sites (the abdomen, pectoral region, eye, hand, thigh and foot) were measured (using infrared thermography) during nocturnal polysomnography in 29 9-day-old preterm neonates (postmenstrual age: 209 9 days).

Eligibility Criteria:
Inclusion Criteria:

* premature newborns 25 to 32 weeks of amenorrhea;
* arrival in the Neonatal Medicine Unit \<12 hours of life;
* need for management in a closed incubator;
* availability of an incubator equipped with communication card.

Exclusion Criteria:

* premature newborns\> 32 weeks of amenorrhea;
* arrival in the Neonatal Medicine unit after 12 hours of life;
* presence of malformation syndrome or serious heart disease;
* pathology requiring management within the first 10 days of life;
* Apgar score \<5 at 10 minutes of life;
* need for initial management in an open incubator;
* unavailability of an incubator equipped with a communication card
Asparagus Capsule Consumption and Blood Sugar and Lipids and Oxidative Stress

Participants were 44 overweight and obese persons, male and female, age 18-59 years. Participants were divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups. They received health screenings including history taking, mental health questionnaire, and vital signs, height and body weight, body composition, fat distribution measurements and oral glucose tolerance test. Then, a venipuncture was conducted to determine blood glucose, insulin, lipids malondialdehyde and protein carbonyl levels.

The study design was cross-sectional. Participants were 44 overweight and obese persons, male and female, age 18-59 years. Participants were divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups. They received health screenings including history taking, mental health questionnaire, and vital signs, height and body weight, body composition, fat distribution measurements and oral glucose tolerance test. Then, a venipuncture was conducted to determine blood glucose, insulin, lipids malondialdehyde and protein carbonyl levels. Analysis of covariance was used to analyze parameters between groups and paired t-test was used to analyze parameters intra-group.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman, aged between 18 to 59 years
* Body mass index more than 23 (Asian criteria)
* No history of hypertension, diabetes, cardiovascular disease, respiratory disease, endocrine disease, neuromuscular disease, musculoskeletal disease, liver disease, renal disease, immune disease, infectious disease, or cancer
* No regular intake of dietary supplements, i.e., vitamins, antioxidants
* No regular smokers or alcohol drinkers (\>2 times per week)
* Not sportman or regular exerciser (\>2 times per week or \>150 min per week)
* No food allergy, especially shoot

Exclusion Criteria:

- Current signs or symptoms of infection, i.e., fever, hyperpnea, dyspnea, and palpitations.
Data Mining: Precision Analytical Retrospective Data Correlation

Data from previously analyzed clinical samples tested by Precision Analytical, Inc. will be mined to identify and select samples from patients reporting hormone supplement use. Patient demographics (BMI, for example), different therapies and expected changes in hormone levels will be analyzed and hormone metabolite patterns will be compared. Samples will be deidentified prior to analysis.

The investigators have a list of 10 estrogen metabolites, 8 androgen metabolites, two progesterone metabolites, 4 cortisol metabolites, free cortisol, six organic acids, 8-hydroxy-2'-deoxyguanosine (8-OHdG), and melatonin that are measured on patient urine samples and cortisol and cortisone on patient saliva samples. The investigators would like to both reinforce the validation of the accuracy of these urinary markers and examine how these markers associate with patient demographics, symptoms, hormone therapy doses and routes of administration.

This study will involve analysis of existing data from routine clinical care. All data will be deidentified and each set of results will be given a study ID number. The key will be held by Danielle Martinot and will contain only the original Precision Analytical sample accession number and the new study ID (identification). No identifying PHI (Protected Health Information) will be accessible to the PI.

These data will be used to evaluate the following hypotheses: 1) Urinary hormone measures accurately reflect expected changes in hormones with regard to circadian rhythm, menstrual status, and use of hormonal medications; 2) Urinary metabolites of cortisol will show a stronger association with body mass index and symptoms related to cortisol production as compared to salivary measures; 3) Urine values of reproductive hormones and organic acids will correlate to the dosing of estrogen and androgens more strongly than to progesterone creams; 4) 8-OHdG, a measure of oxidative stress, and melatonin will be correlated with age and BMI; and 5) Urinary hormone measures will capture age-related changes in hormone regulation.

Eligibility Criteria:
Inclusion Criteria:

* Had testing done at Precision Analytical between 2016 and 2019

Exclusion Criteria:

* Varies by data analysis
Maintaining Autonomy as we Age. Strategy Training for Age-related Executive Dysfunction.

Healthy older adults with self-reported cognitive difficulties who receive strategy training will demonstrate greater performance benefits on measures of real-world activities, relative to those receiving a control intervention, immediately post treatment and at follow-up.


Eligibility Criteria:
Inclusion Criteria:

* All participants must score within 1.5 standard deviation (SD) of age and education-corrected normative data for the Montreal Cognitive Assessment and on a battery of neuropsychological tests of attention, memory and executive function (which will insure that participants are unlikely to meet the criteria for Mild Cognitive Impairment (MCI)).
* No clinically relevant depression (scores ≤22) on the Center for Epidemiologic Studies Depression Scale (CES-D)
* Fluent in written and spoken English
* Self-reported complains about cognitive function

Exclusion Criteria:

* Recent bereavement (within last 6 months)
* History of neurological disease
* Psychiatric illness requiring hospitalization and/or history or current substance abuse
Renal Hemodynamics and Tubular Function in Patients With Obstructive Sleep Apnea and Healthy Controls

Nitrogen-oxide (NO) plays an important role for blood pressure regulation, renal hemodynamics, and the renal excretion of sodium. NO is synthesized from L-arginine in the vascular endothelium and have a very short half-life in plasma and is therefore very difficult to measure directly.

L-mono-methyl-L-arginine (L-NMMA) is an analogue to L-arginine and a competitive inhibitor of NO, and therefore can be used to study the effect of NO on the circulation. In normal subjects, infusion of L-NMMA will cause an increase in blood pressure, decreased renal plasma-flow, decreased glomerular filtration rate, and a decreased excretion of sodium.

Hypothesis: Patients with obstructive sleep apnea has a decreased activity in the NO-system. This is contributing to the hypertension often seen in these patients. Decreased activity in the NO-system can be revealed by diminished fall in renal hemodynamic and sodium excretion after infusion of L-NMMA.


Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea

Exclusion Criteria:

* Drug or alcohol abuse
* Pregnancy
* Disease of the heart, lungs, liver, kidney or endocrine organs
* Cerebral infarction
* Diabetes
* Gastrointestinal disease
GLP-1 - Regulatory Mechanism of Postprandial Glycemia

Synthetic GLP-1 lowers postprandial (pp) glycemia by stimulating insulin, inhibiting glucagon, and delaying gastric emptying. However, the effects of the endogenous peptide are largely unknown. Using the specific GLP-1 receptor antagonist exendin(9-39)amide (Ex(9-39)) the investigators recently showed that GLP-1 released during intestinal meal perfusion acts as an incretin hormone and as an enterogastrone. As the relative contributions of these effects to controll postprandial glycemia are unclear, the investigators used Ex(9-39) to investigate the mechanisms of action of GLP-1 after an oral meal in humans.

Two experiments were performed in random order in 12 healthy subjects. After a 50-min basal period subjects ingested a 412 kcal mixed semisolid meal containing 30g oatmeal, labelled with 99mTc-Sn-colloid. Gastric emptying was measured by high-resolution scintigraphy until 210 min after meal ingestion. Saline (SAL) or Ex(9-39) at 900 pmol/kg/min was intravenously infused during the two experiments. In addition, in 6 of the 12 subjects gastric motility was measured by antroduodenal manometry and gastric barostat. AUC: pp incremental area under the curve. Lag period (LP): time to 10% emptying.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject
* \>=18 years of age
* No medication

Exclusion Criteria:

* Acute disease
* Metabolic disease
* On medication
* Pregnancy, breast feeding
* Gastrointestinal surgery
* Dyspeptische Symptome (Völlegefühl, Blähungen, abdominelle Schmerzereignisse, Übelkeit, Erbrechen, Sodbrennen)
* Teilnahme an einer klinischen Studie in den vergangenen 6 Monaten
Muscular and Functional Performance in FAIS Patients

Following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) decreased hip muscle strength for adduction, extension, flexion, and external rotation including impaired functional performance have been observed. However, no studies are lacking on more demanding muscular and functional parameters such as hip muscle rate of force development and reactive strength index. Information on such muscular properties following hip arthroscopy for FAIS may help guide future planning of post-operative rehabilitation strategies.

This is a cross-sectional study with an embedded prospective non-randomized study. The aim of the cross-sectional study is to investigate hip muscle function and functional performance in patients who have undergone hip arthroscopy for FAIS during the preceding 6-30 months.

The aim of the prospective non-randomized study is to investigate the effect of a 12-week structured and supervised physiotherapy-led intervention aiming at improving hip muscular function on self-reported hip and groin function including hip muscle function and functional performance.

Forty-five subjects from the Capital Region with an age of 18-40, who have undergone a hip arthroscopy for FAIS during the last 6-30 months, will be included in the cross-sectional study. Additionally, all included subjects will be offered to take part in the prospective non-randomized study consisting of 12 weeks of supervised and structured physiotherapy-led treatment.

The below measures will be obtained at baseline, and at 12-weeks follow-up if subjects are included in the prospective study. All testing, and supervised physiotherapy-led treatment, will be performed at Hvidovre Hospital:

1. Hip muscle function
2. Single leg jump performance
3. Self-reported hip and groin function
4. Evaluation of return to sport
5. Evaluation of satisfaction regarding usual-care post-operative rehabilitation


Eligibility Criteria:
Inclusion Criteria:

* Male/female at the age of 18-40 years at the time of surgery
* Undergone hip arthroscopy for FAIS during the previous 6-30 months (surgical procedure: cam resection and labral surgery)
* Pre-operative cam morphology specified as an alpha angle ≥55°

Exclusion Criteria:

* Pre-surgery joint space width \<3 mm
* Any of the following surgical procedures at any time: extra articular surgery of the hip joint (except capsular closure), microfracture, periacetabular osteotomy, and surgery of the ligamentum teres; previous hip arthroscopy in the same hip joint; previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia (Lateral Center Edge Angle \<25°), and/or avascular necrosis; Any rheumatoid disease in the hip joint such as synovial chondromatosis.