cyrilzakka/clinical-trials huggingface dataset:
Iron Bioavailability From MyPyramid Menus

This study will measure nonheme iron absorption from each of the 7 daily MyPyramid menus. Such measurements will confirm whether modifications are needed to meet dietary iron recommendations and will provide data useful for validation algorithms to calculate dietary iron bioavailability.

Nonheme iron absorption is measured with 59Fe tracer added to a 1-day menu, with iron retention detected two weeks later in a whole body scintillation counter. Each subject has iron absorption measured from each of 7 1-d menus formulated to meet the US dietary guidelines (MyPyramid menus), with the order of menus randomly assigned. Each subject participates for 14 wk to test all 7 menus.

Eligibility Criteria:
Inclusion Criteria:

* Women 21 to 50 years old

Exclusion Criteria:

* Anemia,
* High blood pressure,
* Disorders affecting iron absorption or retention,
* Underlying medical conditions,
* Taking medication other than birth control pills or hormone replacement therapy,
* Pregnancy,
* Daily use of analgesics
A Study for PD-1 Antibody JS001 in MSI-H Advanced or Recurrent Colorectal Cancer

To observe the efficacy of PD-1 antibody JS001 in the treatment of participants with microsatellite instability-high (MSI-H) advanced or recurrent colorectal cancer, so as to provide sufficient evidence for MSI-H as a biomarker of PD-1/PD-L1 inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand the study and sign informed consent voluntarily;
* Histologically confirmed advanced or recurrent colorectal cancer, and MSI detection identified MSI-H;
* Patients who have previously received first-line or above chemotherapy or targeted therapy and failed to the treatment or experienced recurrence;
* At least one measurable lesion (RECIST 1.1);
* Agree to provide tumor tissue samples and Pathology reports related to the specimens;
* Aged 18 to 75 years, gender not limited;
* Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1; 8. Expected survival ≥3 months;
* Laboratory test values must meet the following standards within 7 days before enrollment;
* Women of reproductive age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the study drug use

Exclusion Criteria:

* Uncontrolled or symptomatic hypercalcemia;
* Had major surgery or had not fully recovered from previous surgery within 4 weeks before enrollment;
* central nervous system(CNS) metastases;
* Bone metastases;
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently) allow the patient to have a catheter indwelling;
* Having a history of idiopathic pulmonary fibrosis, organic pneumonia;
* Uncontrolled active infection, including but not limited to acute pneumonia;
* Have other malignant tumors at the same time;
* The patient has any active autoimmune diseases or a history of autoimmune diseases;
* Liver diseases of known clinical significance, including active viral viral hepatitis, alcoholic hepatitis or other hepatitis, cirrhosis, fatty liver and hereditary liver diseases.
* Previous use of anti-PD-1 antibody, anti-PD-l1 antibody, anti-PD-l2 antibody or anti-CTLA-4 antibody;
* Patients with active tuberculosis (TB);
* Received systemic immunosuppressive within 4 weeks prior to day 1 of the first cycle;
* Pregnancy test positive;
* Known human immunodeficiency virus (HIV) infection;
* A history of severe allergy, anaphylaxis or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;
* Those who are known to be allergic to biological drugs produced by hamster ovary cells in China, or to citric acid monohydrate, sodium citrate dihydrate, mannitol and polysorbate (components of the experimental drugs);
* Patients who have previously received allogeneic stem cells or parenchymal organ transplantation.
The Effects of Therapeutic Recreation Activities on Emotional Adjustment of Individuals With Intellectual Disabilities

The aim of this study was to determine the effect of Therapeutic Recreation Activities on Emotional Adjustment of Adolescents With Intellactual Disabilities. The research was carried out at Meram Melike Hatun Special Education Vocational School in Konya. The study took place between March 2019 and May 2019. The parents of the participants who participated in the study consisted of the experimental group (n = 17) and the remaining parents (n = 17) formed the control group and the sample group (n = 34). The personal information form which measures demographic characteristics developed by the researchers according to the literature, and Hacettepe Emotional Adjustment Scale were used. Data were analyzed in SPSS 22 program. According to Kolmogorov-Smirnov Z test, sample group was not normal. For this reason, non-parametric tests were performed. In descriptive data, the mean, number, percentage will be used; Comparative statistics were made according to the assumptions of non-parametric test (Wilcoxon test, Mann Whitney U test). Therapeutic Recreation Activities was applied as total of 16 sessions, consisting of two sessions per week and each session lasting about 1 hour. The program was implemented by researcher.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Having a physical disability,
* Having Down syndrome
Prediction of Acute Kidney Injury in Patients With Sepsis Using Venous Excess Ultrasound Score

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis and septic shock are major healthcare problems, killing between one in three and one in six of those they affect. organ dysfunction can be represented by the Sequential Organ Failure Assessment (SOFA) score of 2 points or more (respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less), which is associated with an in- hospital mortality greater than 10%.

Septic shock is defined as a subset of sepsis in which profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone. Patients with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (\>18 mg/dL) in the absence of hypovolemia. This combination is associated with hospital mortality rates greater than 40%.

All patients with two out of four of Systemic Inflammatory Response Syndrome (SIRS) criteria (heart rate greater than 90, respiratory rate greater than 20, temperature greater or equal to 38 ⁰ C or less than 36⁰ C, altered mental state) and suspected infection and one of the following risk factors ( Age greater than 65 years, Recent surgery Immunocompromised AIDS, chemotherapy, neutropenia, diabetes, renal failure, hepatic failure, cancer, alcoholism)should be considered at risk of sepsis according to emergency department sepsis guidelines 2022.

The VExUS score ranges from Grades 0-3. In Grade 0, a non- dilated IVC (\< 2 cm) indicates that no congestion is present. In Grades 1- 3, the IVC diameter is \> 2 cm. In Grade 1, a dilated IVC and any combination of mildly abnormal flow patterns (but no severe features) indicates mild congestion. In Grade 2, a dilated IVC and one severely abnormal flow pattern indicates moderate congestion. In Grade 3, a dilated IVC and two or more severely abnormal flow patterns indicates severe congestion.

Eligibility Criteria:
Inclusion Criteria:

* All patients with sepsis.
* Patients aged between 21 and 65.
* Both sexes

Exclusion Criteria:

* Patients refused to participate in the study.
* Renal failure.
* Right ventricular dysfunction and dilatation.
* Moderate to severe tricuspid regurge.
* Cases of cirrhosis with liver cell failure.
* Inadequate window.
* IVC thrombus
The Effect of General and Spinal Anesthesia on Neutrophil-to-lymphocyte Ratio

The aim of the study was to evaluate the effects of anesthetic techniques (general and spinal anesthesia) on umbilical cord neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and mean platelet volume (MPV) in patients undergoing cesarean section.

This study was designed to evaluate the effects of anesthetic techniques (general and spinal anesthesia) on umbilical cord NLR, PLR and MPV in patients undergoing cesarean section.

The primary endpoint was to compare the effects of general and spinal anesthesia on umbilical cord NLR. Secondary endpoints were determined the general and spinal anesthesia on routine umbilical cord PLR, MPV and newborn Apgar scores at 1st and 5th min.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 45 years
* American Society of Anesthesiology (ASA) II-III
* elective ceserean surgery

Exclusion Criteria:

* declining to give written informed consent
* under 18 years of age or over 45 years of age
* factors affecting NLR, PLR and MPV such as preeclampsia, HELLP syndrome or premature rupture of membranes
* history of neurological and/or neuromucular disease
* cooperation cannot be established
* emergency surgery
Evaluation of Efficacy of Microneedling and Topical Methotrexate Versus Microneedling and Topical 5-flourouracil in Treatment of Vitillgo Patients

Vitiligo is a depigmenting skin disorder, characterized by the selective loss of melanocytes, which in turn leads to loss of pigment in the affected areas of the skin It considerd as autoimmune disease, associated with genetic and environmental factors together with metabolic, oxidative stress and cell detachment abnormalities The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic . with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide 5-Flourouracil is an antimetabolite analogue of the naturally occurring pyrimidine uracil which is metabolised via the same metabolic pathways as uracil Due to its antimitotic activity, topical 5-Flourouracil is a useful therapy for the treatment of many dermatological disorders characterized by a high mitotic rate Clinically, localized hyperpigmentations have been reported during systemic treatment of various cancers by 5-Flourouracil. Usually, these hyperpigmented lesions are located on the normally pigmented extremities (hands and feet) and tongue.

Methotrexate as an antimetabolite and antifolate drug is a time-tested effective treatment extensively used in various autoimmune disorders in low to moderate doses with good efficacy, safety, and tolerability on a long-term basis .

Methotrexate treatment resulted in the decrease of the number of TNF-α-producing T cells, whereas the number of T cells producing IL-10 after polyclonal activation increased, in another study .


Eligibility Criteria:
Inclusion Criteria:

* • Age :main 18 and above years old.

  * Stable vitiligo (each patient has 3separated patches of depigmentation at least).

Exclusion Criteria:• History of keloid formation.

* Patients with systemic diseases (diabetes, bleeding disorders)
* Patients who are receiving chemotherapy or radiotherapy
Ultrasonic System for Cataract Characterization and Optimal Phacoemulsification Energy Evaluation

This study aims to assess the performance of an ultrasonic system for automatic classification of cataract type and severity, as well as the estimation of the optimal phacoemulsification energy. Ultrasonic signals from the lens will be acquired with the Experimental Medical Device (ESUS) in participants with cataract, and in healthy subjects (control).

The proposed technique may represent an important advance in cataract treatment. The quantitative and automatic classification of cataract type and severity, and the estimation of the optimal phacoemulsification energy is may represent a valuable tool for surgical planning, reducing complications associated to excessive levels of phacoemulsification energy, as well as the times spent on surgeries. This device may be relevant not only for patients, but also for public health systems, reducing waiting lists and associated costs.

This is a prospective, pivotal, non-blinded study. Fifty (50) participants will be recruited at the Coimbra Surgical Center of Portugal. The study will be conducted on subjects with age-related cataract, and on healthy subjects as control group. Since this is a pilot study, no sample size estimation has been implemented. The statistical power will be determined at the end of the study. Only per-protocol participants will be considered on statistical analysis.

Procedures involved. The ultrasonic system (Experimental Medical Device - ESUS) works in A-scan mode, with an acoustic working frequency of 20 MHz. From the ultrasonic signals backscattered from the lenses, acoustic parameters will be extracted, and used for automatic algorithms implementation. This study will be implemented once.

Slit lamp with LOCS III classification will be used as comparator. Contrast sensitivity test results will be used for incipient cataract detection, where slit lamp may present some limitations. Optical coherence tomography and specular microscopy will help on detecting postoperative complications; other complications identified by the physician will be also considered. Surgical parameters as phacoemulsification energy and surgical time will help on phacoemulsification energy evaluation.

Safety assessment. The system uses an ophthalmic probe. There are not anticipated adverse events related to the procedures involved in the use of the ultrasonic system, or any other procedure in the protocol. The safety conditions will be monitored through the occurrence of unanticipated adverse events or serious adverse events. If these situations occur, the event will be reported to the competent authorities (in agreement with the current regulation) and the corrective actions will be implemented.

Eligibility Criteria:
Inclusion criteria:

Cataract group:

* Patients with age-related cataract;
* Indication of phacoemulsification surgery

Control group:

• Patients without cataract

Exclusion criteria:

• Presence of any other ophthalmological condition or systemic disease that could affect the results
A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervical Cancer

This is a single-arm, single-center phase II clinical study to explore the efficacy and safety of sintilimab combined with concurrent chemoradiation therapy as treatment in women with locally advanced cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* Has high-risk locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3 or FIGO 2018 Stages IIA2-IVA.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1
* Adequate hematological, renal and hepatic functions:Hemoglobin \> 9.0 g/dl; Neutrophils \> 2000 cells/μl; ANC \> 1.5 × 10\^9/L;Platelets \> 100 × 10\^9/L;

Exclusion Criteria:

* Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
* Has a known history of Human Immunodeficiency Virus (HIV) infection.
* Prior malignancies (other than curable non-melanoma skin cancer) within 5 years
Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years

This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 34 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in mental health outcomes (e.g., depression) and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT.

This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 34 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in depression (primary outcome), secondary mental health outcomes (e.g., anxiety, stress, and grief), and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling adults (aged 18 years or older) living with spinal cord injuries sustained within 5 years
* having at least mild depression measured by the Patient Health Questionnaire-9
* having a computer or a smartphone and internet access at home

Exclusion Criteria:

* having cognitive deficits or language barriers that might impede study participation
* having suicidal attempts within 6 months;
* having a prior experience with acceptance and commitment therapy
Contemporary Transvenous Lead Extraction Outcomes

Presentation of procedural safety and outcomes data from a high volume TLE centre

Transvenous lead extraction is crucial procedure in the longterm management of patients with implanted pacemakers or cardioverter defibrillators.

Our study presents the patient and procedural characteristics as well as the outcome data of a cohort undergoing transvenous lead extraction (TLE) with olny mechanical extraction tools at a high-volume TLE centre.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing a lead removal procedure

Exclusion Criteria:

* minors
Clinical Outcome of Birmingham Hip Resurfacing (BHR) Using VISIONAIRE Femoral Alignment Guide

The primary objective of this study is to investigate the accuracy of the femoral implant placement utilizing the VISIONAIRE Femoral Alignment Guide in Birmingham Hip Resurfacing (BHR) surgery postoperatively after total hip resurfacing using the BHR System.

This is a prospective, multi- site, clinical study of clinical outcomes following hip resurfacing using VISIONAIRE Femoral Alignment Guide. The objective of this study is to evaluate the safety and efficacy of the blocks and to assess alignment of the BHR system when using VISIONAIRE Femoral Alignment Guide. This study will also document any device-related surgical complications or adverse radiographic observations.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, at least 21 years of age, inclusive, and skeletally mature.
2. Patient diagnosed with osteoarthritis of the hip requiring primary total hip resurfacing due to:

   * Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
   * Inflammatory arthritis such as rheumatoid arthritis.
3. Patient is willing to consent to participate in the study
4. Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
5. Patient meets medical clearance to have surgery required for this study

Exclusion Criteria:

1. Patient with infection or sepsis.
2. Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
3. Patient is pregnant or plans to become pregnant during the course of the study.
4. Patient known to have insufficient bone stock to support the BHR device including:

   * Subjects with severe osteopenia should not receive a BHR procedure. Patients with a family history of severe osteoporosis or severe osteopenia.
   * Subjects with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT Grade) should not receive a BHR.
   * Subjects with multiple cysts of the femoral head (\>1cm) should not receive a BHR.
   * Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
5. Patient has known moderate to severe renal insufficiency. Subjects on medications (such as high-dose or chronic aminoglycoside treatment) or with co-morbidities (such as diabetes) that increase the risk of future, significant renal impairment should be advised of the possibility of increase in systemic metal ion concentration.
6. Patient has a known sensitivity to materials in the device.
7. Patient is immuno-suppressed.
8. Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
9. Patient has BMI \>40.