cyrilzakka/clinical-trials huggingface dataset:
The Effects of Meditation on Stress and Fatigue

A randomized controlled trial was conducted with nurses practicing meditation for six weeks, compared to a control group with no intervention. Stress and fatigue levels were measured using validated scales at baseline and post-intervention.

Participants in the intervention group underwent a meditation practice for 20 minutes, three times a week for six weeks. The meditation sessions were led by a meditation expert with 8 years of experience and conducted online via WhatsApp in a group setting. No intervention was given to the participants in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Intensive care nurses with at least 1 year of experience in the intensive care unit.
* Nurses without chronic obstructive pulmonary disease, heart failure, asthma, or other conditions that could hinder breathing exercises.
* Nurses without hearing and communication issues, psychiatric diagnoses (e.g., major depression).
* Nurses who have not attended meditation, yoga, or breathing exercise classes in the past six months.
* Nurses willing to participate in the study were included in the sample.

Exclusion Criteria:

* Nurses who do not attend at least one of the meditation sessions conducted by the meditation expert.
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC)

To evaluate the efficacy of TAI combine toripalimab in advanced HCC.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* not previous treated for tumor;
* cannot accepted hepatectomy;
* the lab test could meet:

  * neutrophil count≥2.0×109/L;
  * hemoglobin≥100g/L;
  * platelet count≥75×109/L;
  * serum albumin≥35g/L;
  * total bilirubin\<2-times upper limit of normal;
  * ALT\<3-times upper limit of normal;
  * AST\<3-times upper limit of normal;
  * serum creatine\<1.5-times upper limit of normal;
  * PT≤upper limit of normal plus 4 seconds;
  * INR≤2.2;
* sign up consent;

Exclusion Criteria:

* cannot tolerate TAI or toripalimab;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy;
Intraoperative Examination of Sentinel Node in Endometrial Cancer (TRSGO-SLN-003)

More than half of the cases with macrometastatic sentinel lymph node (SLN) have non-SLN metastasis and leaving these nodes in-situ may impair the survival. This study assessed the diagnostic accuracy of intraoperative SLN frozen section examination and scrape cytology as a possible solution for management of SLN positive patients. Clinical early stage endometrial cancer patients who underwent SLN algorithm and intraoperative frozen section or scrape cytology to evaluate SLN status for metastasis were analyzed retrospectively. Intraoperative examination findings were compared with final pathology results and diagnostic accuracy of frozen section and scrape cytology were evaluated.

Frozen section: Lymph nodes up to 2 mm were embedded as a whole. Lymph nodes between 2-5 mm were cut in half along their long axis and nodes larger than 5 mm were sliced in neat, parallel slices at 2-3 mm intervals-slicing was perpendicular to the long axis of the node. Then whole of the SLNs were stained with hematoxylin and eosin (H\&E) and examined by frozen section.

Scrape Cytology: SLNs were cut into 3-mm-thick pieces along their long axis. If the lymph node was smaller than 3 mm, it was cut in half. Both sides of the pieces were scraped separately by an edge of a glass slide or a lancet gently. Obtained materials were smeared immediately onto a slide and placed in ethanol for fixation. Then, all slides were stained with H\&E and examined.

The results were reported to the surgeon as positive (metastatic) or negative with the numbers of lymph nodes. After intraoperative examination, lymph nodes were put into formalin solution and sent for final pathologic examination.

Data analyses were performed using SPSS Version 21.0 (IBM Corporation, Armonk, NYC, USA). Shapiro-Wilk test was performed to determine whether the data were normally distributed. Descriptive statistics of continuous variables were compared between groups using Mann-Whitney U test. The Chi-square test or Fisher's exact test (when chi-square test assumptions do not hold due to low expected cell counts) were used to compare categorical variables between groups. Continuous variables were presented as median and min-max values, whereas categorical variables were presented as number and percentage. A p value of \<0.05 was considered statistically significant. Performance of each protocol to predict treatment success was assessed using confidence intervals with respect to sensitivity, specificity, positive predictive value, and negative predictive value.

Eligibility Criteria:
Inclusion Criteria:

* Patients with apparently early stage endometrial cancer whose SLNs were evaluated intraoperatively were included to this study

Exclusion Criteria:

* Patients with gross metastatic disease
* Patients who had contraindications to dyes (iodine allergy or hepatic impairments)
Evaluation of OE-MRI in Patients With H&N Cancer

Assessment of the use of oxygen enhanced MRI scanning in a cohort of patients with head and neck squamous cell carcinomas to identify areas of hypoxia with tumours and relate this to treatment outcomes.

Oxygen-enhanced MRI (OE-MRI) is a technique being actively investigated for imaging hypoxia within cancer tissues. Preliminary clinical data demonstrates the feasibility of using this methodology to study patients with head and neck squamous cell carcinoma (HNSCC). The investigators wish to investigate using this methodology to identify hypoxic subvolumes within HNSCC that may have greater resistance to standard radiotherapy treatment and investigate the association of such hypoxic regions with treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

Non-patient Volunteer Inclusion Criteria:

* Age 18 years and above
* Signed written informed consent

Patient Inclusion Criteria:

* Histologically proven or strong clinical suspicion of squamous cell carcinoma of the head and neck
* Suitable for undergoing radical radiotherapy or chemoradiotherapy according to local protocols within the head and neck Cancer MDT
* Age 18 years and above
* Adequate physical fitness (WHO performance status 0 to 2)
* Signed written informed consent

Exclusion Criteria:

Non-patient Volunteer Exclusion Criteria:

* Contraindications to MRI scans as identified following completion of the Nottingham University Hospitals NHS Trust (NUH) standard MR safety screening protocol
* Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen
* Volunteers who are pregnant as identified through the NUH standard MR safety screening protocol

Patient Exclusion Criteria:

* Poor physical fitness (WHO performance status greater than 2)
* Contraindications to MRI scans as identified following completion of the NUH standard MR safety screening protocol
* Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen
* Patients who are pregnant or breast-feeding (due to IV contrast use in the routine clinical scan) as identified through the NUH standard MR safety screening protocol
Clinical and Molecular Study of CHARGE Syndrom

1. Clinical description of a French cohort of patients with CHARGE syndrome.
2. Search any phenotype-genotype correlation in typical, atypical or incomplete form of the syndrome
3. Using Next generation Sequencing, try to identify other genes involved in this syndrome, as the CHD7 gene is involved in only 40-60% of cases


Eligibility Criteria:
Inclusion Criteria: Clinical criteria

Major criteria:

* Ocular coloboma
* Chonamal atresia and/or cleft palate
* Semi-CircularCanals hypoplasia

Minor criteria:

* Cranial nerves
* Hypothalamic-pituitary deficiency
* Internal or external ear malformation
* Cardiac, esophageal malformations
* Intellectual Deficiency

Diagnosis criteria:

* Typical CHARGE: 3 major criteria or 2 major + 2 minor
* Partial CHARGE: 2 major + 1 minor
* Atypical CHARGE: 2 major without minor or 1 major + 2 minor

Exclusion Criteria:

* Absent consentment for genetic analysis
Determination of the Validity of One-Minute Sit-to-Stand Test in Obese and Overweight Children and Adolescents

Obese individuals need to be evaluated comprehensively before exercise programs are determined. Determination of exercise intolerance is important for the detection of functional limitations. One minute sit to stand test (1MSTST) can be used as an alternative to cardiopulmonary exercise tests (CPET) or field tests. It is easy to use, quick to apply, valid and reliable, and applicable even in small areas. In addition, it is a simple assessment adequate for children's needs and behaviors and can be easily applied both in the clinic and at home, making it easier to use in children. Studies have shown that 1MSTST is a valid test in chronic obstructive pulmonary disease (COPD), cystic fibrosis, interstitial lung disease, and, healthy children and adolescents. However, no study has been found regarding the validity of its use in obese children and adolescents.The aim of our study is to investigate the validity and reliability of 1MSTST in overweight-obese children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Being in the 8-18 age range.
* Being overweight (between 85 and 95 according to the Body Mass Index percentile).
* Being obese (over 95 based on the Body Mass Index percentile).
* Not doing any vigorous exercise two hours before the test.

Exclusion Criteria:

* History of hospitalization in the last month for a reason that may affect physical performance.
* Having neurological, musculoskeletal disease that prevents exercise tests.
* Uncontrollable medical conditions (Cardiovascular, pulmonary disease, etc.).
* Visual and/or vestibular disorders.
An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

Open-label exloratory pharmacodynamic and pharmacogenomic study to evaluate teh biologic effects of 3 dose levels (1mg, 5 mg, and 15 mg) of temsirolimus administered orally once daily for approximately 4 weeks (+/- 2 weeks) before prostatectomy


Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed diagnosis of adenocarcinoma of the prostate gland via a minimum of 6 core biopsy samples.
* Subjects must be a candidate for radical prostatectomy
* No evidence of metastatic disease as determined by CT scans and bone scans

  * More criteria apply

Exclusion Criteria:

* Subjects from whom sufficient diagnostic biopsy material is not available for full characterization of the tumor
* Active Infection requiring antibiotic therapy, or serious intercurrent illness, active bleeding, or ongoing urinary tract infection necessitating rapid or emergent surgical resection
* Subjects who have had hormonal injection or implants which will last longer than 6 months

  * More criteria apply
Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery

The investigators aimed to show the renal damage caused by increased intra-abdominal pressure in laparoscopic surgeries and to investigate whether its reflection on NIRS would be clinically effective.The main question it aims to answer are:

Does pneumoperitoneum cause renal damage?

NRS monitoring will be performed in patients undergoing laparoscopic surgery. Preoperative and postoperative blood tests will be performed at certain hours. N-GAL, urea and creatinine values will be recorded.

Renal NIRS monitoring will be performed in patients undergoing laparoscopic cholecystectomy surgery. Age, gender, BMI, ASA scores, hemogblin/hematocrit values, intraoperative hemodynamic parameters, NIRS values, N-GAL (preoperative, 2nd hour and 24th hour), urea/creatinine (preoperative, postoperative 24th hour) values of the patients will be recorded. .

Before the general anesthesia is performed, the renal tissues of the patients will be visualized by ultrasound, the skin-renal cortex distances will be measured, and suitable patients will be included in the study. Basal rSO2 values will be recorded by placing NIRS probes under the 10-11. intercostal space in the bilateral posterior lateral flank region.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergoing elective laparoscopic cholecystectomi surgery lasting longer than 60 minutes
* BMI:18-25
* skin-renal cortex distance measured less than 4 cm on ultrasound
* ASA I-III

Exclusion Criteria:

* patient who did not give consent
* patient who had renal operation before,
* infection, abscess, catheter in the perirenal region
* hemodynamically unstable patients,
* patients with renal pathology and abnormal kidney function tests,
* emergency cases
Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion

Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion

This is an interventional study designed to gather data on real world utilization of Acoustic Resonance Therapy for treating moderate to severe nasal congestion

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Present with symptoms of chronic nasal congestion
* Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening

Exclusion Criteria:

* Head, nasal or sinus surgery within 3 months
* Pregnancy
One MORE for Chronic Pain

This study will be a single-site, two-arm randomized controlled trial conducted among chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually via a HIPAA compliant virtual meeting platform.


Eligibility Criteria:
Inclusion Criteria:

* men/women ≥18 years of age
* current chronic pain diagnosis
* reporting pain ≥3 on 0-10 scale

Exclusion Criteria:

* unstable illness judged by clinician to interfere with study participation
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.

This study evaluated whether or not tolvaptan is potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total kidney volume increase, while impacting the onset, severity, and progression of other important consequences of ADPKD.

During the 3-week titration phase, tolvaptan or placebo was titrated in weekly intervals from lowest to highest tolerated levels given in split-dose regimens of 45/15 mg, 60/30 mg and 90/30 mg orally upon awakening and approximately 9 hours later. As soon as a subject could not tolerate a given dose, the titration phase was over and the maintenance phase began at the dose level tolerated. The maintenance phase lasted to Month 36. Subjects were able to titrate down at any point during the study. Subjects were able to titrate up during the maintenance phase with Medical Monitor approval.

Eligibility Criteria:
Inclusion Criteria:

* Legal adult age and able to give Informed Consent.
* Adult subjects with a diagnosis of ADPKD. A diagnosis of ADPKD (age 18 or 20-50) required several cysts in each kidney (3 if by sonography, 5 if by CT or MRI) in those with a family history of ADPKD and 10 cysts (by any radiologic method) in each kidney and exclusion of other cystic kidney diseases if there was no family history.
* Willingness to comply with reproductive precautions, if female.
* Estimated creatinine clearance ≥ 60 mL/min. Estimated from serum creatinine during screening using Cockcroft-Gault with correction for gender and race, where possible.
* Rapidly progressive kidney growth (total volume ≥ 750 cc) by magnetic resonance imaging (MRI) at randomization.

Exclusion Criteria:

* Prior exposure to tolvaptan or other experimental PKD therapies.
* Currently taking medication for purpose of affecting PKD cysts.
* Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
* In the opinion of the study investigator or sponsor may present a safety risk or confound study objectives.
* Patients who are unlikely to adequately comply with study procedures.
* Patients having contraindications to MRI.
* Patients taking medications or having any illnesses likely to affect ADPKD outcomes.
AMH Predicts Postchemotherapy Menopause in Premenopausal Breast Cancer Patients

To determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause

For early breast cancer women who are premenopausal, after receiving chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy), not using OFS as ovarian suppression, AMH, E2 and FSH levels will be measured by blood sampling before chemotherapy, at the end of chemotherapy and 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after chemotherapy. The menstrual status of patients will be also followed up. At several timing, investigators will analyze AMH level, E2 level, FSH level, proportion of unmeasured AMH (AMH≤0.02ng/ml), proportion of E2 that conforms to menopausal status (E2≤30ng/L), proportion of FSH that conforms to menopausal status (FSH \> 30U/L), proportion of persistent amenia (no menstruation from the end of chemotherapy to the evaluation time) and incidence of adverse reactions

Eligibility Criteria:
Inclusion Criteria:

1. Age over 40(include 40 years old), or before 60, female
2. Primary invasive breast cancer diagnosed by histopathology, except of occult breast cancer, inflammatory breast cancer and Paget's disease
3. Operable patients with no distant metastases at diagnosis (stage T1-T3, any N, M0)
4. The patient was at premenopausal status when first diagnosed (had menstruation in the last 12 months or hormone levels not reached menopause when diagnosed, E2 \> 30ng/L, FSH≤30U/L)
5. The patient has used chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) after diagnosis

Exclusion Criteria:

1. Age before 40, or over 60(include 60 years old)
2. Patient who accepted bilateral ovariectomy or ovarian radiotherapy
3. Patient who used gonadotropin-releasing hormone agonist ( GnRHa)
4. Stage IV (metastatic) breast cancer
5. The patient was at postmenopausal status when first diagnosed (no menstruation in the past 12 months or hormone levels reached menopause when diagnosed, E2≤30ng/L, FSH \> 30U/L)
6. The patient has not used chemotherapy (neoadjuvant or adjuvant chemotherapy) since diagnosis
7. The investigator determines that the patient has any other condition that make her unfit to participate in the study
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the health of patients with human Chronic Obstructive Pulmonary Disease.

This will be an open-label, non-randomized multi-center patient sponsored study of Autologous SVF (AD-SVF) implantation after liposuction using an IV delivery system and Inhalation infusion. AD-SVF will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered intravenously.

The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for IV delivery. The number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process.

Eligibility Criteria:
Inclusion Criteria:

* A prior diagnosis of moderate or severe COPD
* GOLD III and IV
* Age between 25 and 80 years
* Up to date on all age and gender appropriate cancer screening per American Cancer Society

Exclusion Criteria:

* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* Severe asthma that would contraindicate surgery
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Unwilling and/or not able to give written informed consent.
Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia

This study evaluates the use of AMAG-423 (Digoxin Immune Fab) in addition to expectant management in the treatment of severe preeclampsia as compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Fetal gestational age 23 0/7 to 31 6/7 weeks
* Treated with expectant management
* Meets modified ACOG criteria for severe preeclampsia
* Willing and able to provide written, informed consent

Exclusion Criteria:

* Decision to deliver within 24 hours has been made
* Weight \> 150 kg
* Eclampsia
* Significant antecedent obstetrical problems
* Clinically significant fetal anomaly or chromosomal abnormalities
* Chronic renal disease
* Active hepatic disease, antiphospholipid antibody syndrome, or lupus
* Unstable medical or psychiatric disorder
* Need for use of digitalis like products
* History of anaphylactic allergic reactions
* Prior use of antibodies/fab fragments from sheep
* Serum creatinine ≥ 2.0 mg/dL
* Platelet count \< 50,000
* Pulmonary edema
* Estimated fetal weight \< 5th percentile