cyrilzakka/clinical-trials huggingface dataset:
The Effect of H. Pylori Infection on Iron Metabolism

The purpose of this study is to determine if Helicobacter pylori (H. pylori) gastritis results in abnormal iron metabolism in patients with iron deficiency anemia (IDA), and to determine if this is due to strain variations in the H. pylori organism.

There is suggestive evidence that H. pylori gastritis (without peptic ulcer disease) is a cause of IDA. There have been individual case reports and case series describing patients with refractory IDA that resolved following successful H. pylori treatment. The effect of H. pylori on iron metabolism will be studied through specific aims: 1. To assess whether H. pylori results in abnormal oral iron absorption 2. To assess if differences in H. pylori strains are associated with iron deficiency due to: a. genetic differences in H. pylori strains or b. differences in the pattern of gastritis which could be due to host, bacterial or environmental factors 3. To assess if H. pylori infection results in storage of iron in the gastric mucosa and an elevated gastric iron concentration. The study will consist of three aspects: 1. Determining whether oral iron absorption is abnormal for H. pylori-positive IDA patients, and comparison of oral iron absorption for H. pylori positive and negative IDA patients. This will also include an experimental component in which oral iron absorption will be repeated after H. pylori treatment for H. pylori-infected IDA subjects (and after an equivalent time period for H. pylori negative controls to exclude changes in iron absorption that occur over time). 2. Comparison of H. pylori strain characteristics for IDA patients and non-anemic H. pylori-infected controls. Characterization of H. pylori strains will include: genetic analysis using a whole genome microarray technique that assesses the presence or absence of H. pylori genes, evaluation of expression of genes related to iron metabolism, and comparison of pattern of gastritis (pan gastritis vs. antrum-predominant). 3. Determination of whether H. pylori stores a significant quantity of iron in the gastric mucosa in vivo. This will be assessed by measuring the iron concentration in mucosal biopsy specimens and comparing results for H. pylori-infected IDA patients to H. pylori-uninfected IDA controls.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* iron deficiency anemia (IDA) defined as: Hgb \< 14 g/L for men and 12 g/L for women, and a serum ferritin level less than 45 ug/L

Exclusion Criteria:

* Obvious non-GI cause of blood loss
* Chronic renal failure (BUN\>60, Creatinine \> 4)
* Hemolytic anemia, thalassemia, aplastic anemia
* Known alcoholism or cirrhosis of the liver
* Regular use (\>3x weekly) of NSAIDS
* Prior gastric resection
* Celiac disease
* Known GI or hematologic malignancy
* Known inflammatory bowel disease
Prevention of Type 2 Diabetes With Vitamin D

The work plan will have the following S\&T components. Component 1: Cross-sectional Study

Cross-sectional study will be of 1.5 years where 400 women from rural will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure.

Component 2: Prospective Study

This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women with vitamin D deficiency. The women will be recruited from cross-sectional study, out patient department and health camps and they will be followed up for 2 years. The women will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women aged 20-60 years.

Exclusion Criteria:

* Received Vitamin D or calcium supplementation in the previous six months.
* On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (e.g. metformin, thiazolidenediones, steroids etc.) and on any medication that activate steroid and xenobiotic receptors, and drugs used in transplantation
* Pregnancy and lactation at time of study
* Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
* Known case of HIV infection.
* Known case of diabetes mellitus and other endocrine disorders.
Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery

The aim of this study was to compare between the safety and efficacy of the harmonic shears and the commonly used clip technique in achieving safe closure and division of the cystic duct in the laparoscopic cholecystectomy in day surgery setting


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Cholelithiasis
* Age under 65 yr old
* BMI under 35
* ASA I or II

Exclusion Criteria:

* Acute cholecystitis
* Suspect of common bile duct stones
24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG

A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.


Eligibility Criteria:
Inclusion Criteria:

* Patient has XFG and is older than 29 years
* The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
* Patient can be safely washed out without risk for significant deterioration
* Distance best corrected Snelen visual acuity better than 0.1
* No contraindication to prostaglandins or β-blockers
* No history of lack of response (\<10% reduction) to any medication
* Patient can understand the instructions and comply to medications
* Open normal appearing angles
* No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Exclusion Criteria:

* History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
* Patient is a female of childbearing potential or lactating mother
Robotic Urogynecological Surgery: Hospital Stay and Perioperative Complications

The purpose of this study is to assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery.


Eligibility Criteria:
Inclusion Criteria:

* The first 21 women who underwent DaVinci-assisted robotic sacrocolpopexy and who did not complete postoperative QA questionnaires from 09/01/2007 through 09/01/2008.

Exclusion Criteria:

* Any women not meeting inclusion criteria.
Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)

This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.

Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. Toripalimab is a humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. In the present study, we design a single-arm, single center Phase II trial to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, UICC stage IV gastric cancer;
* no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;
* at least one measurable lesion;
* received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;
* ECOG performance status 2;
* the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN), ALT and AST \<2.5 × ULN and if liver metastases, BIL \< 3 × ULN, ALT and AST \<5 × ULN; Serum Cr ≤ 1.5 × ULN;
* Patient's written declaration of consent obtained;
* Estimated life expectancy \> 3 months;

Exclusion Criteria:

* harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;
* dMMR/MSI-H;
* Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);
* have received anlotinib or other immune checkpoint inhibitor ;
* with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;
* severe wounds or surgery 4 weeks before recruitment;
* received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents;
* History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively.
* pregnancy or breast feeding;
* absent or restricted legal capacity;
* a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
Correlation Between PTP1B Expression and Organ Failure During Sepsis

Despite major advances in the treatment and understanding of the pathophysiological mechanisms, mortality of severe sepsis remains high, ranging from 25 to 50%. With a prevalence \> 20% in intensive care units, it is now in a population increasingly aging with many co-morbidities, a real public health problem. Thus, changes in treatment to physiological axes could change the prognosis of these patients. Protein Tyrosine Phosphatase 1B (PTP1B) is involved in the negative regulation of many cellular pathways such as the response to insulin, leptin and certain growth factors and endothelial nitric oxide production. PTP1B appears to be particularly involved in the control of endothelial function and insulin secretion. Under these conditions, encouraging results have been obtained in a model of insulin resistance (obesity, diabetes) and as part of pro-angiogenic therapy by inhibition of PTP1B on models of heart failure. Recent advances have broadened the pathophysiological implications of PTP1B conferring a potential role in the regulation of inflammatory processes. In an experimental model of septic shock (Inserm 1096), the investigators demonstrated a significant improvement in survival and cardiovascular function in genetically deficient mice PTP1B (PTP1B - / -). Finally, PTP1B is involved in the downregulation of the signaling pathway of insulin via a feedback phenomenon. Septic shock induces many changes in carbohydrate metabolism. These changes result in hyperglycemia associated with insulin resistance, an independent risk factor of morbidity and mortality. Taken together, these data suggest that the expression of PTP1B could be useful in septic patients by modulating insulin resistance and thus the prognosis of these patients. This justifies the investigator clinical research project on the relationship between the expression of PTP1B levels, glycemic status and prognosis evaluated by the SOFA score in patients with septic shock with multiple organ failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients in ICU for septic shock
* Person belonging to a social security system
* Informed patient who signed consent
* Contraceptive method in women of reproductive age

Exclusion Criteria:

* Pregnancy
* Patient not able to take a decision because of an administrative or legal decision
* Patient participating to an other interventional study
* BMI \> 30 kg/m2
* Diabetes with specific treatment
A Study For Patients With EGFRm (Epidermal Growth Factor Receptor Mutant) Lung Cancer

Phase 1 - open label, multi-center, non-randomized, safety, pharmacokinetic and pharmacodynamics dose escalation study of PF-06459988 as a single agent in patients with advance EGFRm NSCLC (del 19, L858R, +/- T790M). The resulting PF-06459988 dose selected from the phase 1 portion will undergo a series of sub-studies to fully characterize the impact of food, antacid and CYP3A4 inhibitors/inducers. The PK studies are in addition to the MTD expansion and will be completed prior to the initiation of Phase 2. Phase 2 is an open label, multi-center single-arm study of PF-06459988 for the assessment of antitumor activity in patients with advanced EGFRm (del 19 or L858R) NSCLC with T790M.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of histological or cytologically confirmed diagnosis of locally advanced or metastatic EGFRm (del19 or L858R) NSCLC that is resistant to standard therapy. Patients must have progressed on treatment with an EGFR TKI, and may have also received other line of therapy.
* Tissue available (formalin fixed paraffin embedded (FFPE) block or 10 unstained sections (5 micron)
* Patients must be willing to participate in additional PK studies as required (cohort dependent); patients will be informed of which PK studies are required prior to consenting for study participation
* Adequate Bone Marrow Function (Complete Blood Count laboratory test results)
* Adequate Liver Function (Laboratory test)

Exclusion Criteria:

* Previously diagnosed brain metastases, unless the patient has completed their treatment and has recovered from the acute effects of radiation therapy or surgery prior to the study registration, have discontinued corticosteroid treatment for these metastases for at least 2 weeks and are neurologically stable
* Systemic anti-cancer therapy within 4 weeks of starting study treatment excluding EGFR TKIs. Patients on EGFR TKIs must discontinue the agent for a minimum of 5 days prior to starting study drug
* Hypertension that cannot be controlled by medication (150/100 mmHg despite optimal medical therapy).
Supporting the Mental Health Workforce

Emotional Health Association will engage Los Angeles County Department of Mental Health providers that employ peer workers in a training and technical assistance intervention designed to support, increase, and retain an effective peer workforce. This intervention consists of a Co-Learning Collaborative, several training sessions, and the creation of Implementation Teams. Peer workers will also be encouraged to attend Recovery International, an established network of self-help support groups for mental health. Dr. Louis Brown will lead an evaluation of the efficacy of the intervention. This study will inform the use of peer workers as a component of the mental health workforce.

Evaluation of the the intervention with the peer workforce will be conducted through administration of web-based surveys of peer workers and peer supervisors at baseline and follow-up (10 months post-baseline). These two surveys will be administered to peer workers and peer supervisors at sites enrolled in the study. A letter of informational detailing the risks of participation will accompany the survey. Individuals who do not complete the web-based survey will be invited to complete a telephone interview with the same questions. Sites (where one or more peer supervisors and peer workers are located) will be randomized to either the intervention group or standard practice control group. The intervention group will engage in Co-Learning Collaborative, several training sessions, and the creation of Implementation Teams. Peer workers from the intervention group will also be encouraged to attend Recovery International, an established network of self-help support groups for mental health. Analysis of the surveys collected from both study groups will be conducted to assess the efficacy of the intervention and provide Emotional Health Association with a final report.

Eligibility Criteria:
Inclusion Criteria:

* All service providing sites within the Los Angeles Department of Mental Health will be invited to participate in the study. Sites not affiliated with the Los Angeles Department of Mental Health will be allowed to enroll in the study if they express interest but will not be actively recruited.
* Participants must be a peer worker or supervisor of peer workers at a site participating in the study.

Exclusion Criteria:

* Peers who do not receive pay and volunteer for less that 15 hours per week.
Safety and Efficacy of UC-MSCs in Patients With Psoriasis Vulgaris

The purpose of this study is to investigate the safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis vulgaris. Any adverse events related to UC-MSCs infusion will be monitored and the patients will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) in the baseline and after MSCs infusions.

Psoriasis is considered as an incurable immune-mediated inflammatory skin disease. The widely used treatments include topical agents, systemic medications and biologic agents, but all of them have some drawbacks or limitations. Besides, non-standardized treatment or the disease itself may lead transformation to other diseases, which add more importance to finding improved management strategies.

Mesenchymal stem cells (MSCs) are a heterogeneous population of cells that can differentiate into bone, cartilage and fat cells. They have several functions, such as migration to skin lesions, immunomodulation, limitation of autoimmunity and local paracrine effects. It reported MSCs have already been used in some kinds of autoimmune disease, such as systemic lupus erythematosus (SLE), systemic sclerosis, crohn disease, rheumatoid arthritis et al.

In this study, consenting umbilical cords are donated by healthy donors. After several processing steps, UC-MSCs are separated and froze for future infusions. When volunteers are recruited, their condition will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Then MSCs will be infused according to a standard scheme. After all 6 infusions, the patient will be re-assessed by the PASI and DLQI and will be followed up for one year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stable psoriasis vulgaris for at least 6 months
* Baseline Psoriasis Area and Severity Index (PASI) score \>= 8
* Despite systemic or topical treatment, psoriasis is still in active or recurrent condition
* No other psoriasis management (topical or systemic) during the UC-MSCs infusions
* Willing and able to comply with all study requirements and provide informed consent

Exclusion Criteria:

* Other types of psoriasis, such as pustular psoriasis, psoriatic arthritis
* With other disease
* Systemic treatments within 4 weeks before the baseline visit
* Topical treatment within 2 weeks before the baseline visit
* Uncontrolled active infections
* Evidence of infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
* History of severe systemic disease or malignancy
* Pregnant or lactating females, or willing to have a baby in the next year
* Cannot be traced on time
* Any other situations not suitable for this study determined by the investigators
Menopause and Oral Microbiome

The study examines the saliva and dental plaque microbiome of women aged 35-65 in two groups: postmenopausal (case) and premenopausal (control). For this purpose, Illumina Platform to sequence 16S rRNA gene regions will be used. The data will be analyzed using the QIIME2 bioinformatics tool. Serum estradiol levels will be determined by the ELISA method. The investigators will examine the relationship between microbiome data (alpha diversity, beta diversity, and relative abundance) and menopausal status, estradiol levels, and periodontal health status using linear statistical models. Clinical samples of the study will be collected at Ege University, and the laboratory studies and sequence analysis will be conducted at the Forsyth Institute in Boston.

To obtain longitudinal data besides the cross-sectional data, the investigators will contact the participants of a previous study from 2019, whose saliva, dental plaque, and serum samples are currently being stored at -80 °C, and ask them to participate for a second sampling.


Eligibility Criteria:
Inclusion Criteria Regularly mensturating women over 35 years of age Postmenopausal women under 65 years of age

-

Exclusion Criteria:

- Antibiotic useage in last 3 months Being in menopausal transition phase
A PRPCT to Assess the Efficacy & Safety of Chronic Pain Rehab Training Software for Alleviating Chronic Secondary Musculoskeletal Pain

A prospective, randomized, parallel-controlled clinical trial to evaluate the effectiveness and safety of chronic pain rehabilitation training software in assisting in the relief of chronic secondary musculoskeletal pain

A PRPCT to assess the efficacy \& safety of chronic pain rehab training software for alleviating chronic secondary musculoskeletal pain

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥18 years old.
* Average pain intensity≥4 on a 0-10 numerical rating scale (NRS) in the past 24 hours.
* Be able to communicate in Chinese.
* Be able to read and write Chinese.
* Willing to comply with study procedures and restrictions.
* Willing and able to sign informed consent.

Exclusion Criteria:

* Shingles on the eyes, ears, head, face, or hands.
* Trigeminal neuralgia.
* Severe vision impairment. (Patients with clear vision wearing glasses or contact lenses are allowed)
* Severe hearing impairment.
* Disease or medical condition predisposing to nausea or dizziness, such as insufficient blood supply to the brain, vestibular dysfunction,cholecystitis, etc.
* History of severe motion sickness.
* Injury to eyes, ears, face, or neck that impedes comfortable use of mixed reality.
* Injury or dysfunction of hands or upper limbs that impedes comfortable use of mixed reality.
* Diagnosis of cognitive impairment, epilepsy, dementia, migraines or other neurological diseases that may prevent the use of mixed reality.
* History of mental illness, including depression, generalized anxiety disorder, schizophrenia, etc.
* Females currently pregnant.
* Current or completion of participation within 4 weeks before screening in any interventional clinical study
* Patients whom the investigator considers not suitable to participate in this study.