cyrilzakka/clinical-trials huggingface dataset:
Estrogen and Diabetes

Diabetes has recently been referred to as "the epidemic of the 21st century". The reason why women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (CVD) compared to men with type 1 diabetes is unknown.The purpose of this study is to investigate whether or not estrogen contributes to vascular dysfunction in premenopausal women with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Both men and premenopausal
* Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles
* All races
* Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)

Exclusion Criteria:

* Clinical diagnosis of hepatic, cardiovascular, or renal disease
* Uncontrolled Diabetes (HbA1c\>9%)
* Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
* Proteinuria
* Uncontrolled Hypertension (\>140/90 mmHg on therapy)
* Hormonal use of birth control (past 3 months)
* Pregnancy
* Oligomenorrhea
* Direct vasoactive medications (i.e. nitrates)
* Anti-estrogens (i.e. SERMs)
* Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)
* Undetectable Anti-Mullerian Hormone (AMH) following screening
The Effect of Supplementation With Two Different Doses of Vitamin D on Bone Mineral Density, Vitamin D Levels and Hand Grip Strength in Children With Diabetes Mellitus Type 1

The aim of the study is to assess the effect of 12 month supplementation with two different doses of vitamin D ( 500 vs 1000) on bone mineral density, serum 25 hydroxyvitamin D levels and hand grip strength in preadolescents with diabetes mellitus type 1.

100 children in the of age 8 -11 with diabetes mellitus type 1 lasting for more than 3 months, without history of diabetic ketoacidosis during previous month, without other chronic disease which may affect calcium-phosphorus metabolism will be randomized in a double blind controlled trial to supplement them with either 500 IU or 1000 IU vitamin D. Every 3 months, in spring summer,autumn and winter serum level of calcium,25-hydroxyvitamin D level and HbA1c will be measured. At the entry and at the end of the study patients will have total body and lumbar spine bone mineral density assessment. Every six months hand grip strength will be measured. Additionally at the beginning and after 12 mo of supplementation and at the beginning serum levels of TNF-alfa, osteoprotegerin and IL-6 will be assessed.

Evidence indicates that majority (75-90%) of children with diabetes have lower serum concentrations of vitamin D, which may negatively impacts bone health and can be associated with reduction of muscular strength. There is still unknown what is the optimal dose of vitamin D in these patients for adequate supply of vitamin D throughout the year to assure optimal peak bone mass and muscle strengthThe aim of the study is to assess the effect of 12 month supplementation with two different doses of vitamin D ( 500 vs 1000) on bone mineral density, serum 25 hydroxyvitamin D levels and hand grip strength in preadolescents with diabetes mellitus type 1.

100 children in the of age 8 -11 with diabetes mellitus type 1 lasting for more than 3 months, without history of diabetic ketoacidosis during previous month, without other chronic disease which may affect calcium-phosphorus metabolism will be randomized in a double blind controlled trial to supplement them with either 500 IU or 1000 IU vitamin D. Every 3 months, in spring summer,autumn and winter serum level of calcium,25-hydroxyvitamin D level and HbA1c will be measured. At the entry and at the end of the study patients will have total body and lumbar spine bone mineral density assessment. Every six months hand grip strength will be measured. Additionally at the beginning and after 12 mo of supplementation and at the beginning serum levels of TNF-alfa, osteoprotegerin and IL-6 will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* 8-11 years
* Diabetes type I lasting for more than 3 months
* informed consent given

Exclusion Criteria:

* Adolescence (Tanner stage ≥ 2 for each of the variable)
* Chronic diseases affecting calcium-phosphorus metabolism (hepatic disease, chronic kidney disease, primary phosphate deficiencies, end organ resistance to 1,25OH S genetically)
* Hypervitaminosis D \> 200 ng/ml (500 nmol/L)
* Diabetic ketoacidosis during last month
Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants

The purpose of this study is to estimate the effect PF-07321332/Ritonavir and Ritonavir on Midazolam (a cytochrome P450 \[CYP\]3A4 substrate) in Healthy Adult Participants.


Eligibility Criteria:
Inclusion Criteria:

1. Female participants of childbearing potential must have a negative (urine or serum) pregnancy test.
2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

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Exclusion Criteria:

1. Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
3. Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
4. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
5. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or hepatitis C virus (HCVAb). Hepatitis B vaccination is allowed.
6. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
The Effectiveness of an Eating Disorders Prevention Program for Young Women in Saudi Arabia

The trial is a randomized control trial about the effective of an eating disorders prevention programmer for young Saudi women.

The prevention program is title The Body Project. Participants will be Saudi undergraduates from Princess Nourah Bint Abdulrahman University. Sample size is 64 participants. They will be divided randomly to two groups, each group has 32 participants. The first group is the intervention group where the prevention program will be provided. The second group will be the control group where healthy eating education material will be provided. The outcomes will be measured with adapted tools to local culture at three points (pre, post and 3 month follow-up).


Eligibility Criteria:
Inclusion Criteria:

undergraduate Saudi female

Exclusion Criteria:

undergraduate Saudi female with eating disorders
Real-time fMRI for Insular Cortex Brain State-triggered Experience Sampling

In a neuroimaging session, study participants will repeatedly and intermittently report the content of their ongoing, self-generated experiences based on an experience-sampling protocol in which self-report ratings will be triggered based on real-time analysis of the participant's current brain state. The protocol will be conducted while participants are undergoing MRI scanning.

The investigators will develop a new approach called real-time functional MRI (fMRI)-triggered experience-sampling to efficiently sample spontaneous neural events (of a predefined type) and to map those events to specific qualities of self-generated experiences. Within 60 healthy adults, the investigators will use online (real-time) fMRI analysis to detect brain activations and trigger the appearance of visual rating scales so that participants can report their experiences immediately after the occurrence of a neural event of interest. The investigators will develop and validate the approach with a focus on real-time fMRI analysis of the dorsal anterior insular cortex (daIC), a brain region implicated in salience detection that is consistently identified as having aberrant structure, function, and connectivity in psychiatric illness at a transdiagnostic level. Aim 1 is to determine whether spontaneous daIC activation events are time-locked to instances of salient, high-arousal self-generated experience. The investigators will sample self-generated experiences both during instances of daIC activation and during baseline (intermediate daIC activity) events. The investigators hypothesize that daIC activation, relative to baseline events, will be time-locked to self-generated experiences with higher subjective ratings of arousal and vividness (regardless of affective valence). Aim 2 is to determine how distinct instances of daIC activation are coupled to physiological and whole-brain activity. Using a hypothesis-driven approach, the investigators will determine whether spontaneous fMRI activations in the daIC are associated with pupil dilation and activation of the locus coeruleus, a subcortical generator of arousal-related neuromodulation. Additionally, using a more data-driven approach, the investigators will test whether different instances of daIC activation are associated with multiple, distinct whole-brain co-activation patterns, and whether these co-activation patterns are associated with fluctuations in subjective affect (positive vs. negative experiences). If successful, the protocols can later be applied in patients with psychiatric illness and to potentially guide the development of interventions (e.g., neurostimulation, neurofeedback) that aim to target the neural processes that produce self-generated experiences that are core to mental illness.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-35

Exclusion Criteria:

* History of psychiatric or neurological disorder
* contraindication for MRI
Alpha-1 Carrier Genomics Study

The goal of this study is to better understand why some Alpha-1 genotype MZ (PiMZ) individuals develop chronic obstructive pulmonary disease (COPD) while others do not. This study will examine portions of the Alpha-1 gene that are not routinely tested to determine whether other changes in this gene correlate with development and progression of COPD. Participation involves responding to questionnaires about lung health and history, and performing an at-home finger stick to obtain blood spots using a test kit that is mailed. The blood provided will be used for genetic testing and correlation of results with COPD history. Participants will receive their results and access to genetic counseling at the conclusion of the study.

Alpha-1 Antitrypsin Deficiency (AATD, Alpha-1) is the best established genetic risk factor for chronic obstructive pulmonary disease (COPD) and liver disease. Clinical presentation is heterogeneous in most genotypic populations of alpha-1 antitrypsin deficiency (AATD) and genetic variation in the Alpha-1 gene has been incompletely studied. Rare gene alterations that predispose to COPD risks of classic AATD in individuals without a classic homozygous deficiency genotype have not been studied and are important in understanding, testing and treating at-risk populations. Investigators hypothesize that SERPINA1 gene sequencing will find important sequence variations in previously assessed MZ individuals who have COPD compared to age, race, sex, AAT level and smoking status matched MZ individuals who do not have COPD.

The Alpha-1 Carrier Genomics study is a pilot study that will enroll up to 150 MZ individuals. COPD+ and COPD- individuals will be matched on age, sex, race and smoking history. Presence and severity of COPD is assessed by a COPD severity score on questionnaires. Participants will be mailed a test kit to obtain and return a blood sample by finger stick for the purpose of SERPINA1 gene sequencing. Gene sequencing will identify, if present, genomic signatures that may correlate with COPD in this cohort. Participants will receive their results and access to genetic counseling at the conclusion of this study.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. PiMZ individuals who fall into the lower quartile of AAT levels.

Exclusion Criteria:

1. Age \<18 years
2. Known homozygous or compound heterozygous classic severe AATD (e.g. PiSZ, ZZ, Znull)
Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

We aimed to evaluate the hypothalamus-pituitary-adrenal axis in autosomal dominant polycystic kidney disease (ADPKD) patients. Twenty two ADPKD patients and 27 healthy subjects were enrolled.

CONTEXT: Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease and extrarenal manifestations may be observed in many organ systems. Hypothalamus-pituitary-adrenal axis in patients with ADPKD was not evaluated extensively.

OBJECTIVE: We aimed to evaluate the hypothalamus-pituitary-adrenal axis in ADPKD patients.

METHODS: Twenty two ADPKD patients and 27 healthy subjects were enrolled. Basal dehydroepiandrosterone-sulfate (DHEAS) levels and cortisol and dehydroepiandrosterone responses to low dose short adrenocorticotropin stimulation test were assessed. Correlation analyses of these parameters with glomerular filtration rates, renal volumes and pain characteristics in patients with ADPKD were done.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Diagnosis of autosomal dominant polycystic kidney disease

Exclusion Criteria:

* A glomerular filtration rate below 60 ml/min
* History of recent major surgery
* Systemic infections with fever
* Significant hirsutism (Ferriman Gallwey score≥8)
* Congenital adrenal hyperplasia
* Late onset congenital adrenal hyperplasia
* Systemic corticosteroid use (including previous use)
* Topical corticosteroid use
* Menstrual irregularity
* History of thromboembolism
* Uncontrolled diabetes or hypertension
* History of psychosis
* Pregnancy
* Lactation
* History of hypersensitivity to tetracosactin
Application Value of CTCs Detection for Advanced Gastric Cancer Patients

Evaluating the application value of a new circulating tumor cell detection method for advanced gastric cancer patients in prediction of the prognosis and early evaluation of the result of postoperation adjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Subjects eligible for enrollment must meet all of the following criteria:

1. Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures
2. Men or women aged \>= 18 years and \<=75 years.
3. Eastern Cooperative Oncology Group Performance Status (ECOG) \<= 2.
4. Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction.
5. Metastatic disease or locally advanced disease not amenable to curative surgery.
6. Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.
7. Life expectancy of at least 12 weeks with tumor and at least 5 years without tumor from the time of enrollment.
8. No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
9. No prior chemotherapy for advanced disease. -

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

1. Gastric carcinoid, sarcomas, or squamous cell cancer.
2. Pregnant or lactating females.
3. Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
4. Active Hepatitis B or C or history of an HIV infection.
5. Active uncontrolled infection. -
Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy

To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

Background:

To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

Methods:

The study included 62 eyes that underwent successful PPV with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively. The best-corrected visual acuity (BCVA), Amsler test, M-charts, optical coherence tomography (OCT) and microperimetry were performed at 1, 3 and 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosed macula-on and macula-off rhegmatogenous retinal detachment.

Exclusion Criteria:

* history of uveitis,
* diabetic retinopathy,
* previous vitreoretinal surgery,
* glaucoma or eye trauma,
* retinal detachment combined with macular hole or proliferative vitreoretinopathy
A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers

This study compares the immune response to the proposed biosimilar PF-06881894 and the US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6 milligrams \[mg\]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1 of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two treatment periods. In addition, safety assessments will be conducted throughout the study.


Eligibility Criteria:
Inclusion Criteria:

• Healthy males or females between 18 and 65 years of age (both inclusive) with body mass index between 19 and 30 kg/m2, inclusive, and body weight of not \<50 kg or \>95 kg, will be enrolled in this study.

Exclusion Criteria:

* Hematologic laboratory abnormalities (including leukocytosis \[defined as total leukocytes \>11,000/mcL\], leukopenia \[defined as total leukocytes \<4000/mcL\], or neutropenia \[defined as absolute neutrophil count \<1500/mcL\] or thrombocytopenia \[defined as platelet count of \<150,000/mcL\]) or other clinically significant abnormal laboratory evaluations.
* Lack of adequate hepatic or renal reserve.
* Any active systemic or immunologic disease or condition.
* History of biological growth factor exposure.
* Received live vaccination or exposure to communicable viral diseases within 4 weeks prior to Screening.
Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow

The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.

Cancer is frequently associated with pain. In spite of recent improvements in cancer related pain treatment, incidence of cancerous chronic pain did not decrease. Indeed, 15 to 20% of patients are still suffering from intractable pain despite an optimal symptom management.

Treatment of cancer pain is generally based on the WHO analgesic ladder according to 3 steps. Patients with advanced cancer are often treated at WHO step 3 analgesics, i.e. morphine and its derivatives, at high dosages. But increasing the dosage of opioids also leads to accentuation of their adverse events and the corresponding risks.

At this stage of the disease, in patients with failure of conventional analgesic therapy, intrathecal injection of analgesics can be decided in order to relieve pain. 2 types of pumps allow intrathecal morphine administration : continuous or programmable flow. In this study, we want to compare the quality of analgesia obtained through these 2 flows.

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old.
* Patient with advanced cancer.
* Patient with severe pain, i.e. a mean daily pain score \> or = 5 on an numeric rating scale.
* Failure of optimal conventional analgesic therapy : either due to intolerable adverse events or to lack of efficacy, i.e. after having tried opioid rotation techniques, different way of administration, use of rapid-acting narcotics to control acute episodes of pain, use of intravenous morphine by PCA pump.
* Possibility of return home
* Dated and signed informed consent form.

Exclusion Criteria:

* Patient's refusal to participate in the study.
* Ongoing pregnancy.
* Ongoing systemic infection.
* Injection site infection.
* Estimated survival less than 90 days.
* Allergy or intolerance to morphine.
* Contraindication to implantation of an intrathecal catheter.
* Patient treated with a powerful CYP1A2 inhibitor, such as fluvoxamine or enoxacin.
* Intrathecal chemotherapy planned.
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra

This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation.

The objective of this clinical investigation is to establish the feasibility, efficacy and safety of the TiLOOP® Bra.


Eligibility Criteria:
Inclusion Criteria:

The TiLOOP®Bra is designed to assist oncologically indexed skin sparing mastectomy or subcutaneous mastectomy with preservation of the nipple-areola-complex during primary breast reconstruction, secondary breast reconstruction or corrective breast surgery. Patients shall be included if they meet all of the following criteria:

Clinical Criteria (reason):

* women with indication of prophylactic operation or oncoplastic operation with support of a mesh implant
* women with histologically confirmed breast cancer or precancerosis or genetic pre-existing conditions with increased risk of breast cancer or with a family history
* the health of women must comply with ECOG (Eastern Cooperative Oncology Group) performance status 0-2

Study-related inclusion criteria - Legal reasons:

* Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
* Patient information has been handed out and all written consents are at hand.
* Patient is between 18 and 70 years old.

Exclusion Criteria:

Patients must be excluded if any of the following conditions exist or cannot be excluded:

Device-related exclusion criteria (contraindications):

Pathological or physical condition precluding such as:

* Pregnancy or breast-feeding patients
* Known intolerance to the mesh-implants under investigation.

Study-related exclusion criteria - Medical reasons:

* metastatic breast cancer
* medicamentous regulated diabetes with blood sugar level \>250
* inadequate bone marrow function with neutrophil granulocytes \<1500 and blood plates \< 10000/µl
* patient with known contraindication to mesh-implants or plastic-reconstructive breast operations

Study-related exclusion criteria - Legal reasons:

* Lack of written patients informed consent.
* Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
* Patient is institutionalized by court or official order (MPG§20.3).
* Participation in another operative clinical investigation.

It is thought that the study-related exclusion criteria will not significantly influence the sample of the population under investigation.