cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Quality of Self-collected Blood Spot Specimens for Laboratory HIV Testing - An InvolveMENt Sub Study

We will invite a convenience sample of up to 45 enrolled subjects to participate in an optional, self-administered blood specimen collection procedure to determine optimal procedures for collection.

Participants will be recruited to this one-time assessment during their follow-up visits. After completing a consent procedure specific to this study component, participants will be provided with instructions on how to fully self-administer the procedure of a finger stick and also blotting to collect a blood specimen using a 1, 3 or 5 blood spot specimen collection card. These specimens will be labeled with the participant's unique identification number, and no other identifying information. The dried blood spots will be evaluated by a laboratorian to assess quality, but will not be tested for HIV. This evaluation will help determine what number of self-collected dried blood spots yields the highest usable quantity of sample for HIV testing. There will be a separate monetary incentive of $30 for this procedure.

Eligibility Criteria:
Inclusion Criteria:

* Must be either currently enrolled or previously enrolled in the InvolveMENt Study through Emory University
* Over 18 years old
* HIV Negative

Exclusion Criteria:

* Not enrolled or previously enrolled in the InvolveMENt Study through Emory University
* Under 18 years old
* HIV Positive
Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes

This study aimed to assess if a multidimensional individually tailored intervention, including Norwegian Psychomotor Physiotherapy (NPMP), elements of cognitive behavioural therapy and a rehabilitation plan, helped reduce inspiratory distress and dysfunctional breathing in adolescent athletes with EILO. A mixed methods design, which combined qualitative and quantitative research, was used. Data, including subjective experiences of respiratory distress, findings from NPMP body examinations and objective measurements of lung function and aerobic capacity were gathered before and after a five month intervention involving 18 participants.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent athletes with symptoms of EILO
* Referred to Norwegian Psychomotor Physiotherapy

Exclusion Criteria:

* Other respiratory symptoms
* Additional diagnosis
FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer

The purpose of this research project is to test if a compound (chemical substance) has a natural tendency to go to prostate cancer. This compound has a small amount of radioactivity attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be detected on a special imaging device called a PET scanner (positron emission tomography). The radiotracer is treated in the body much like an amino acid which is a nutrient required for normal functioning. Tumors also use these nutrients. Earlier studies have shown that this radiotracer may be able to detect prostate cancer.

The investigators will perform a study with 20 patients in whom they know have prostate cancer after a biopsy and who are scheduled for an operation in which the prostate is removed and the nearby lymph nodes are examined. This operation is called prostatectomy. The investigators think that this radiotracer can help us determine where exactly the prostate cancer is present in the prostate or if it has spread. This information may be useful in the future to help with other non-surgical therapy such as radiation beam therapy.

The investigators will compare the results of the FACBC PET scan to the results of the pathology analysis of the removed prostate. In this way the investigators can determine how good a test FACBC PET is for finding out where and if prostate cancer is located in the prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the biopsy samples to see if they can tell why FACBC goes into prostate cancer cells.

This radiotracer has been tested in over 100 human subjects without incident. It has also been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is funding this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older.
* Patients will be scheduled for prostatectomy based on a diagnosis of primary prostate cancer.
* Ability to lie still for PET scanning
* Patients must be able to provide written informed consent.

Exclusion Criteria:

* Age less than 18
* Inability to lie still for PET scanning
* Cannot provide written informed consent.
* Less than 4 weeks since any prior prostate biopsy (to decrease false positive uptake from inflammation).
Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in Postmenopausal Women

The purpose of the study is to evaluate the effect of daily oral intake of DHEA 50 mg for 4 months on reducing vasomotor symptoms (hot flashes) compared to placebo administration in postmenopausal women.

Humans, along with the other primates, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. Much attention has been given to the benefits of DHEA administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid.

This study proposes to study the effect of 50 mg oral DHEA capsules during a period of 4 months administered to postmenopausal women experiencing 50 or more moderate to severe hot flushes per week. Participants will be stratified by the number of hot flushes experienced per week. The two strata are: 50-70 or more than 70 hot flushes per week. During the study several biological and clinical parameters will be evaluated, as well as the reduction of the number of hot flashes and improvement of overall quality of life.

Subjects will be evaluated at specific time intervals during the study for the above mentioned parameters as well as tolerability and adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal women with 50 or more moderate to severe hot flushes.
* Women between 40 to 70 years of age.

Exclusion Criteria:

* Body mass index (BMI) of 35 kg/m2 or more.
* Significant metabolic and endocrine diseases.
* Diagnosis of cancer.
* Use of steroids or drugs that interfere with the metabolism of estrogen.
* Use of any systemic estrogen, progestin, or DHEA in the eight weeks prior to randomization.
* Use of alternative therapies or natural products to treat postmenopausal symptoms in the four weeks prior to randomization.
* Palpable fibroids or uterine prolapse: Grade 2 or 3.
* Cigarette smoking
Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants

This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.

Meeting the protein and energy requirements of extremely premature infants in early postnatal life requires early hyperalimentation and the gradual introduction of enteral feedings. Glutamine, which is the most abundant amino acid in the human body and taken up in greatest quantity by the fetus from the placenta, is not routinely provided in neonatal parenteral nutrition preparations.

This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.

Infants received a neurodevelopmental assessment by masked, certified examiners at 18-22 months postmenstrual age.

Eligibility Criteria:
Inclusion Criteria:

* 401-1000 gm
* More than 12 hrs and less than 72 hrs after birth; intravenous access
* Parental consent

Exclusion Criteria:

* One or more major congenital anomalies
* Infants meeting criteria for terminal illness
* Congenital nonbacterial infection with overt signs at birth
A Study of E7080 in Subjects With Advanced Thyroid Cancer

This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally administered once daily (QD) in subjects with advanced thyroid cancer.


Eligibility Criteria:
Inclusion criteria

1. Histologically or clinically diagnosed with thyroid cancer
2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2
3. Adequate laboratory values/organ function tests

Exclusion criteria

Participants with following complication or disease history

1. Brain metastasis
2. Systemic severe infection
3. Significant cardiovascular impairment
4. QTc greater than 480 milliseconds
5. Active hemoptysis
6. Bleeding or thrombotic disorders
7. Having greater than 1+ proteinuria on urine dipstick testing will undergo 24 hour urine collection for quantitative assessment of proteinuria
8. Gastrointestinal malabsorption or any other condition in the opinion of the investigator that might affect the absorption of E7080
9. Major surgery within 3 weeks before enrollment
10. With co-existing effusion requiring drainage
Feasibility, Safety and Efficacy of Remote Ischemic Preconditioning for Symptomatic Intracranial Arterial Stenosis in Octogenarians

Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial arterial stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. age between 80 to 95 years old
2. Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
3. National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4
4. ABCD2 score between 6 to 7
5. stable vital signs, normal hepatic and renal functions
6. no hemorrhagic tendencies

Exclusion Criteria:

1. within 72 hrs of intra-artery or intravenous thrombolysis
2. intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)
3. any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs
4. acute myocardial infarction
5. systolic blood pressure more than 200 mmHg after drug control
6. peripheral blood vessel disease
7. hematologic disease
8. severe hepatic and renal dysfunction
9. severe or unstable concomitant disease
10. cannot tolerate BLIPC or without informed consent
Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT)

Radiotherapy (RT) of the abdomen and/or pelvis is known to cause acute and late gastrointestinal (GI) toxicities. While radiation dose and volume are known risk factors for developing such side effects, recent evidence suggests patterns of disturbance in the composition of the GI microbiota - so called "dysbiosis" - may also promote the host's susceptibility to GI toxicities through impaired intestinal barrier function and inflammation. The IMPRINT-study aims to expand the current knowledge on the role of intestinal bacteria and their metabolites involved in the pathophysiology of radiation-induced GI toxicities by longitudinally examining the microbiota composition (feces), the associated metabolome (blood, feces and urine) and bacterial extracellular vesicles (BEVs) (blood and feces).

The IMPRINT-study is a prospective biomarker study assessing the impact of different treatment field sizes and associated radiation doses on the patient's microbiome and metabolome, whereby the link with radiation-induced GI toxicities will be emphasized. Blood, urine and fecal samples will be longitudinally collected at 4 different time points: (1) shortly before, (2) during and (3) shortly after RT treatment, as well as (4) one-month post-RT. To our knowledge, this is the first clinical research project relating the impact of multiple radiation parameters on fecal-, urine- and blood-based biomarkers to risk of GI toxicities in a homogeneously defined study population.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven (initial) adenocarcinoma of the prostate
* Localized (confined to primary site) and/or regional (spread to regional pelvic lymph nodes) disease stage at diagnosis
* Age ≥ 18 years
* RT is an integral part of the treatment - primary, adjuvant or salvage
* WHO performance status 0-2
* Administration of androgen deprivation therapy (ADT) before RT
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Signed informed consent form (ICF) according to ICH/GCP and national/regional regulations

Exclusion Criteria:

* Other primary tumor (except for non-melanoma skin cancer) diagnosed \< 5 years before enrollment
* Diagnosis of inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis)
* Administration of systemic therapy during RT other that ADT
* Subjected to antibiotic treatment or medically imposed dietary restrictions \< 1 month prior to enrollment
* Body mass index (BMI) \> 35
* Administration of pelvic RT \< 1 year
Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19

The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.

This is a non-interventional transversal research whose main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.

Design:

A multicentric (3 sites) clinical trial

Sample size :

200 patients

Population concerned:

Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.

Duration of participation (treatment + follow-up): until the patient is discharged from the ICU and within 2 months top.

No interim analysis is planned. Analysis will be performed at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the intensive care units of Saint-Antoine, Tenon and Pitié-Salpêtrière hospitals (Paris, France)
* With moderate to severe respiratory distress syndrome and SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab
* informed and not opposed to participation in research
* included within 4 hours following the paatient's admission

Exclusion Criteria:

* Patients under guardianship / curatorship
* Patients under AME
Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression

This project will attempt to enhance and augment the antidepressant efficacy of a commonly used antidepressant in poorly responding bipolar depressed patients.

This is a placebo-controlled study of patients with bipolar I disorder (BPD) utilizing a well-known antidepressant, escitalopram (ESC), in combination with the anti-inflammatory agent, celecoxib (CBX). The investigators hypothesize that combination treatment will lead to a qualitatively and quantitatively augmented response and will result in greater numbers of remitters compared to ESC monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Ages 21 - 65 years old at time of screening visit. Both genders and any race will be accepted.
* Diagnosis of BPD I or II without significant co-morbid secondary medical or psychiatric diagnoses; no substance abuse or dependence during preceding 12 months
* A minimum score of 18 on the first 17 items of the 21-item Hamilton Depression Scale
* Willingness to washout for a reasonable time (depending on the substance) from: Vitamin E and fish oils (\>600 IU/day), non-aspirin NSAIDs or aspirin (\>81 mg/day, H2 receptor antagonists, Ginko biloba, caffeine on morning of blood drawing, and to institute lights-out at 23:00 hours on the nights before blood drawings

Exclusion Criteria:

* Any abnormal findings on the physical exam, ECG, blood/urine or minor infections
* Any pre-existing physical pain condition, including fibromyalgia
* History of peptic ulcer complicated by perforation, hemorrhage, or obstruction; symptoms of peptic ulcer within 4 weeks of enrollment date
* Any substance abuse or dependence during the preceding 12 months
* Clinically significant hypertension, anemia, liver disease, kidney disease, arthritis, diabetes, recurrent migraines, epilepsy, stroke, gum disease, autoimmune disease
* Current use of lithium
* Current use of a stimulant
* Certain steroids including use of hormonal birth control and any systemic or topical corticosteroids (hormone replacement therapy will be allowed)
* Unwillingness to refrain from H2 receptor antagonists, non-aspirin NSAIDs, or aspirin (more than 1 mg/day).
* Use of any anticoagulant agents
* Use of nicotine-containing substances. Subjects who quit smoking more than 3 months prior to assessment may be considered for the study
* Known sensitivity or allergy to the study medications or a need to receive agents that are contra-indicated in combination with CBX or ESC
* Unwillingness to fast and abstain from caffeine on mornings of blood drawings
* A sleep disorder other than insomnia or hypersomnia as a distinct symptom of major depressive disorder (MDD)
* Inability to commit to the follow-up visits between 8 and 11 am
Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)

This is a prospective randomized, double blind, placebo controlled phase II study planned in patients with advanced ACC. The study will be conducted at ASST Spedali Civili Hospital and University of Brescia in Brescia.

As no effective second-line therapies are available for patients with disease progression to EDPM, including modern molecular target therapies and immunotherapy, it is reasonable to expect that no newer drugs or combination regimens will be able to replace EDPM in the next 5 years. Since EDP-M is destined to remain the standard first line therapy, research strategies aimed to improve the efficacy of this regimen are of relevance. In this study, investigators will address the hypotheses that progesterone has a synergistic and/or additive effect to EDP-M in inducing cytotoxicity in ACC cells in vitro and the antineoplastic activity of EDP-M in locally advanced/metastatic ACC patients could be improved by the addition of megestrol acetate.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of ACC
* Locally advanced or metastatic disease not amenable to radical surgery resection
* ECOG performance status 0-2
* Effective contraception
* Life expectancy \> 3 months
* Age \> 18 years
* Adequate bone marrow reserve (neutrophils \>1,000/mm3 and/or platelets \>80,000/mm3) and organ function (including renal, liver and cardiac function)
* Be able to comply with the protocol procedures and provide written informed consent.

Exclusion Criteria:

* History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 2 years
* Renal insufficiency (estimated glomerular filtration rate \[GFR\]\<50 mL/min/1.73 m2) or significant liver insufficiency (serum bilirubin\>2 times the upper normal range and/or serum alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]\>3 times the upper normal range). GFRs will be calculated according to the validated formula (MDRD)
* Pregnancy or breast feeding
* Congestive heart failure (ejection fraction\<45%)
* Preexisting grade 2 peripheral neuropathy
* Previous or current treatment with mitotane or other antineoplastic drugs for ACC
* Previous radiotherapy for ACC
* Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration or that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Patients Seeking a Visual Impairment Certificate

This study investigates the prevalence, causes, and demographic characteristics of patients seeking visual impairment certificates at Assiut Ophthalmology Hospital. Using a prospective cross-sectional design, it aims to identify the magnitude and nature of visual impairment in this population by analyzing clinical data, performing comprehensive eye examinations, and utilizing advanced diagnostic tools.

The study is designed to explore the prevalence, underlying causes, and demographic profiles of patients requesting visual impairment certificates at Assiut Ophthalmology Hospital. It employs a prospective cross-sectional approach, recruiting patients from ophthalmology outpatient clinics who meet the World Health Organization's (WHO) definition of blindness. Blindness is defined as having best-corrected distance visual acuity (BCVA) of 3/60 or less in the better eye or a visual field restricted to 10° or less in the widest diameter of vision.

Eligible participants undergo comprehensive eye examinations, including visual acuity measurement using Snellen charts, slit-lamp biomicroscopy, dilated fundus examination, and automated perimetry for visual field assessment. Advanced investigations such as OCT macula imaging, VEP (visual evoked potential), ERG (electroretinography), ultrasound, and fundus photography are performed to identify the causes of visual impairment. Demographic data-such as age, sex, marital status, occupation, socioeconomic status, education level-and systemic medical history are collected to assess contributing factors.

The sample size was calculated using Epi-info software with a confidence level of 95% and confidence limits of 5%, estimating a minimum of 383 cases. By analyzing clinical findings alongside demographic characteristics, the study aims to provide valuable insights into the magnitude and nature of visual impairment in this specific population. This information could help inform public health strategies and improve services for visually impaired individuals.

Eligibility Criteria:
Inclusion Criteria:

* Patients requesting visual impairment certificate at Assiut ophthalmology hospital having all investigations Visual field, OCT macula, VEP, ERG, US, Fundus photography Werepatients who fulfilled WHO's definition of blindness. The blind patients according to WHO's,were defined as patients having best corrected distance visual acuity (BCVA) of 3/60 or less in the better eye or a visual field restricted to 10 or less in the widest diameter of vision.

Exclusion Criteria:

* Patients unwilling to participate in the study Incomplete or missing investigations