cyrilzakka/clinical-trials huggingface dataset:
Thin Catheter for Hysterosalpigography

Hysterosalpingography is usually painful and the use of thin catheters of IUI could be an attractive alternative . we conducted a randomised controlled trial to compare the standard metal cannula to the thin catheter originally manufactured for intrauterine insemination. Pain assessment was done using visual analogue scale

HSG is widely practiced in our country, however, for cost effective reasons, the standard metal cannula is the only method used at our hospital. It is painful procedure because it requires grasping the cervix with a tenaculum and inducing some cervical dilatation during introduction of the cannula. The aim of this pilot study was to modify the technique of HSG using a thinner than normal catheter, and without grasping the cervix with a tenaculum. Leakage of the dye through the cervix was prevented by pressing on the portiovaginalis of the cervix using the vaginal speculum.

Eligibility Criteria:
Inclusion Criteria:

* infertile women seeking evaluation of fallopian tubes

Exclusion Criteria:

* any woman with allergy to the iodine dye or condition contraindicating pregnancy
Evaluation of the Immediate Effect of Acupuncture on the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain.

The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy subjects will be enrolled in a randomized, single-blind, crossover study. Each patient will receive two forms of treatment in random order: a single session of traditional acupuncture and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine motor control in the upper trapezius muscle before and after treatment. The outcome measures in the group with neck pain will be a numerical pain rating scale (range: 0 \[no pain\] to 10 \[maximum pain\]), documentation of the pain area on a body chart and cervical range of motion. Linear regression analysis will be applied for each individual to investigate associations between the sEMG variables and force (excluding the sixth step). The slopes of the regression lines will be used to measure the sensitivity of the sEMG variables regarding changes in force. The Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS and MDF values in the third and sixth step of the step contraction. Paired samples (Student's t-test or Wilcoxon test) will be used to test differences between third and sixth contraction step. A mixed linear model will be used to analyze and compare the sEMG data during sustained contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2) evaluations. These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the activity of the upper trapezius muscle, as hypothesized. The pain (NRS, PPT and area) and cervical ROM data collected during the four evaluations will also be compared using a mixed linear model. The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows) will be employed for the statistical analysis, with the level of significance set to 5% (p \< 0.05).


Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years
* male and female volunteers

Exclusion Criteria:

* history of neurological disorders
* neck surgery
* chronic neck pain resulting from a traumatic incident
* chronic musculoskeletal condition
* medical diagnosis of fibromyalgia; systemic disease
* connective tissue disorder
* non-tolerance of needles; current pregnancy
* having undergone physical therapy use of analgesic, muscle relaxant.
Predicting Outcomes of GPOEM Using Gastric Electrical Mapping

Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted \<1 month prior to GPOEM. All subjects will then be followed up for 12 months.

This protocol proposes no change to the clinical management of patients which is left to the discretion of the patients' primary clinical team.

Patients as part of this study will undergo a baseline assessment via Gastric Alimetry, and concurrent symptom, quality of life, and health psychology questions.

GPOEM will be performed as per standard site protocol, with data captured in RDCap.

Patients will be followed up at 1-month, 3-month, 6-months, and 12-months using the myCap (REDCap) app.

Participants and clinicians can opt-in for a repeat Gastric Alimetry test at 6 or 12 months following their GPOEM procedure.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Indicated for GPOEM

Exclusion Criteria:

* Pregnant or breast-feeding
* Inability to perform Gastric Alimetry test: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); patients unable to remain in a relaxed reclined position for the test duration.
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study

Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB use, in patients with cystic fibrosis and exocrine pancreatic insufficiency.

Study Entry (Day -14): Baseline blood samples collected for plasma and erythrocyte concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA). Baseline characteristics collected included BMI and cystic fibrosis related diabetes.

Observation Period (Day -14 to Day -8): Subjects followed their usual enteral nutrition regimen with pancreatic enzyme replacement therapy (PERT).

Run-in Period (Day -7 to Day -1): Subjects used Peptamen 1.5 enteral formula at their normal volume of administration from 500 mL to 1,000 mL per feeding with usual PERT regimen.

Treatment Period (Day 0 to Day 90): Subjects used Impact Peptide 1.5 up to a maximum volume of 1,000 mL per feeding with RELiZORB for the 90 day treatment period. Blood screening measurements were repeated at start of treatment period (Day 0), Day 30, Day 60 and Day 90. PERT use with enteral feedings was prohibited. Safety and tolerability were assessed with GI symptom diaries and systematic assessments of adverse events and unanticipated adverse device effects.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of cystic fibrosis
2. Documented history of exocrine pancreatic insufficiency
3. Enteral formula use a minimum of 4x/week, using PERT, consuming an unrestricted fat diet, and willing to use Peptamen 1.5 and Impact Peptide 1.5
4. Written informed consent or assent.

Exclusion Criteria:

1. Uncontrolled diabetes mellitus
2. Signs and symptoms of liver cirrhosis or portal hypertension
3. Lung or liver transplant
4. Active cancer currently receiving cancer treatment
5. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerance, inflammatory bowel disease
Genome Wide SNP Array-based Approach to Detect Micro-cytogenetic Lesions and KIT Mutation to Improve Treatment Outcomes in Patients With Core-binding Factor Positive Acute Myeloid Leukemia

Core binding factor (CBF) positive acute myeloid leukemia (AML) consist of 15% of patients in overall AML, expected to harbor a favorable prognosis. However, around a half of cases relapses. Accordingly, more sophisticated classification in CBF positive AMLs is essential to achieve further improvement in the treatment outcome. The current study is designed to evaluate CBF positive AML patients with genome-wide SNP array and KIT mutation study in CBF positive AML patients diagnosed at the Samsung Medical Center and Hwasun Chonnam National University Hospital, Korea between 1994 and 2008.

1. Construction of the CBF positive AML patient cohort: clinical database establishment (including treatment outcomes and prognosis) and extraction/storage of tumor cell DNAs from marrow samples, then processing of Affymetrix SNP array 6.0.
2. Construction of prognostic predictive model using pharmacogenomics with the results of genotypes and copy number variations (CNVs).
3. Detection of hidden microscopic cytogenetic lesions with SNP array technique, and correlation with clinical outcomes in CBF positive AML.
4. Detection of KIT, FLT3/ITD, and NPM1 gene mutation and its correlation with clinical outcomes in CBF positive AML.

The current study attempts to analyze genetic data of core binding factor (CBF) positive acute myeloid leukemia (AML) using genome wide SNP array technique with tumor DNAs collected at the time of diagnosis.

1. To detect microcytogenetic lesions and will analyze its prognostic significance
2. To analyze genome-wide genotypes and copy number variations (CNVs) using pharmacogenetic approach and will construct a prognostic predictive model
3. To detect KIT, FLT3/ITD and NPM1 mutation and evaluate its prognostic significance. The present study will establish individualized therapy for CBF positive AML, will provide a basis for molecular marker guided clinical trial in CBF positive AML.


Eligibility Criteria:
Inclusion Criteria:

* patients with core binding factor positive acute myeloid leukemia
* 18 years or older
* patients were treated with standard chemotherapy
* patients with available medical record and stored bone marrow specimen at time of diagnosis

Exclusion Criteria:

* no definive criteria
Tight Achilles Tendon, Hyperpronation and Anterior Knee Pains

The purpose of the study is to investigate the prevalence of pain in the anterior part of the knee, amongst youngsters between 16 and 18 years of age.

Furthermore, this trial intends to study the connection between the pain, hyperpronation of the foot and tight Achilles tendon.

We want to find out if there is a need of an early effort in terms of information, training and/or support for the shoes.

All students (around 300) between 16 and 18 years of age from one Gymnasium, receives a questionnaire. They are asked to answer whether they have had pain in the anterior part of their knee within the last month. If so they are invited to participate in a scientific study. An equivalent group with no pain are invited to participate as a control group.

In both groups navicular drop and drift will be measured together with the dorsal flexion. The investigations are made single-blinded as the investigators do not know if the "patient" has pain or not.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent, and for those being under 18 years of age, their parents signature.
* Anterior knee pain syndrome and for the control group: no knee pain syndrome

Exclusion Criteria:

* Former knee surgery
* Any form of arthritis
* Diagnosed meniscus or other injuries in the knee
Validation the Artificial Intelligence System for Automatic Evaluation of the Extent of Intestinal Metaplasia

The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. But its clinical application is limited for at least biopsy samples. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. The investigators designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.

Gastric intestinal metaplasia(GIM) is an important stage in the gastric cancer(GC). The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. However, its need to take at least 4 biopsies is not clinically feasible. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. An EGGIM score of 5 was the best cut off value for identifying OLGIM stage III/IV patients. The investigators have designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 40-75 years who undergo the IEE examination

Exclusion Criteria:

* patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric
* disorders who cannot participate in gastroscopy
* patients with previous surgical procedures on the stomach
* patients with contraindications to biopsy
* patients who refuse to sign the informed consent form
RecurIndex Guided Avoidance of Regional Nodal Irradiation for Node Positive Breast Cancer

The purpose of this study is to validate whether clinically low-risk, and RecurIndex high-risk N1 patients receiving regional lymph node radiotherapy can further improve clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, ≤ 70 years old.
* Eastern Cooperative Oncology Group (ECOG) ≤ 2.
* Postoperative pathology is clearly diagnosed as invasive breast cancer.
* Meet the clinical definition of low risk: ①Axillary lymph node micrometastasis (N1mic) or ②N1 patients who meet the following conditions at the same time, a）Age ≥ 40 years old, b）Vascular tumor thrombus (LVI) negative or allow few positive LVI (excluding extensive or massive LVI), c）Three subtypes are allowed (Lumina A, Lumina B/HER2 negative, Lumina B/HER2 positive) , namely ER positive (ER ≥ 1%), HER2 negative (HER2 expression negative or + by IHC, or 2+ but negative by FISH) or ER positive (ER ≥ 1%), HER2 positive (3+ by IHC, or 2+ but positive by FISH).
* Postoperative pathological diagnosis of axillary lymph node status is any of the following: a. Sentinel lymph node biopsy or axillary lymph node dissection for micrometastasis (N1mic), b. Sentinel lymph node biopsy for 1-2 lymph node macrometastasis (N1sln), c. Sentinel lymph node biopsy + axillary lymph node dissection or simple axillary lymph node dissection for 1-3 lymph node metastasis (N1).
* The primary tumor and breast undergo breast-conserving surgery or total resection ± breast reconstruction (autologous/prosthetic).
* There must be adequate systemic examination (such as chest X-ray, B-ultrasound, CT, etc.) within 3 months before randomization of radiotherapy to confirm that there is no distant metastasis.
* No contralateral breast cancer must be confirmed by molybdenum target and/or MRI within 12 months before randomization of radiotherapy.
* At least 4 courses of adjuvant chemotherapy with anthracycline or taxane should be completed after surgery.
* Radiotherapy must be performed sequentially after the completion of adjuvant chemotherapy, starting no later than 8 weeks after the end of chemotherapy.
* The patient must have sufficient primary fresh frozen specimens or post-paraffin tissue sections for RecurIndex testing.
* No previous history of malignant tumors, except for basal cell carcinoma of the skin.
* Signed an informed consent form.

Exclusion Criteria:

* Postoperative radiotherapy was confirmed as T3-4, N0, N2-3, M1 lesion staging before enrollment.
* Receive any new adjuvant therapy before surgery, including chemotherapy, endocrine therapy, targeted therapy or radiation therapy.
* Patients who underwent total mastectomy and only sentinel lymph node biopsy.
* Have a history of contralateral breast cancer.
* History of chest radiotherapy.
* combined with severe heart, lung, liver, kidney, hematopoietic, neurological diseases, and mental illness.
* History of autoimmune diseases such as scleroderma or active lupus erythematosus.
* pregnant and lactating patients.
* Unable or unwilling to sign an informed consent form.
Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension

This study aims to determine the possible effects of inspiratory muscle training on cardiovascular, respiratory, physical and psychosocial functions in patients with PH.

Pulmonary Hypertension (PH) is a hemodynamic finding related to increase in pulmonary artery pressure. Because PH disease is a progressive, rare disease, it is important for this disease group to prolong the life span and to increase the quality of life and functional capacity. PH patients have been shown to have weakness in peripheral and respiratory muscles.

Patients will be randomly assigned to the inspiratory muscle training and control group. Inspiratory muscle training will be initiated in accordance with the patient at a range of 40-60%. İnspiratory muscle training will be given based on the assessments by the physiotherapist. Patients with PH who come to the routine outpatient clinic and volunteer will be included in the study. The first session will be the evaluation session and the 8-week inspiratory muscle training will be given, the other group will be the control group only. Dyspnoea, diaphragm thickness, pulmonary function, respiratory and peripheral muscle strength, blood pressure, arterial stiffness, physical activity, anxiety, depression and quality of life assessments will be repeated before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Pulmonary Hypertension
* According to the New York Heart Association functional class II - III
* Cases receiving stable medication for 3 months

Exclusion Criteria:

* Conditions which can limit the assessments
* Severe ischemic heart disease
* Acute cor pulmonale
Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL

Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia

This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome negative B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).

Eligibility Criteria:
Inclusion Criteria:

* Age≥15 years old
* Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification
* The immunophenotype of leukemia cells were CD19 and CD22 positive
* Ph- or Ph- like negative
* Anticipated survival time more than 12 weeks;
* Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria:

* History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
* Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
* Pregnant (or lactating) women;
* Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
* Active infection of hepatitis B virus or hepatitis C virus;
* Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
* Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
* Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
* Other uncontrolled diseases that were not suitable for this trial;
* Patients with HIV infection;
* Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs. This study is being conducted to confirm the performance of the Archimedes System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor is conducted.


Eligibility Criteria:
Inclusion Criteria:

1. Age 21-75 years at screening
2. Highly suspicious pulmonary nodule(s), defined as distinct nodule with a diameter of ≥8mm in its largest dimension
3. No known endobronchial tumor
4. Tumor located anywhere in parenchymal tissue \>1 cm from pleura and accessible bronchoscopically through a POE.
5. Willing to participate in all aspects of study protocol for duration of study
6. Able to understand study requirements
7. Subject or legally authorized representative signs study-related informed consent document

Exclusion Criteria:

1. Any contraindication to bronchoscopy, for example:

   1. Untreatable life-threatening arrhythmias
   2. Inability to adequately oxygenate the patient during the procedure
   3. Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)
   4. Recent myocardial infarction
   5. Previously diagnosed high-grade tracheal obstruction
   6. Uncorrectable coagulopathy
2. Known coagulopathy
3. Platelet dysfunction or platelet count \< 100 x 103 cells/mm3
4. History of major bleeding with bronchoscopy
5. Suspected pulmonary hypertension: additional testing required, such as echocardiogram
6. Moderate-to-severe pulmonary fibrosis
7. Severe emphysema or COPD: additional testing and PI consent is required
8. Bullae \>5 cm located in vicinity of target nodule or tunnel
9. Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:

   1. ASA class \> 3
   2. \> stage 3 heart failure
   3. severe cachexia
   4. severe respiratory insufficiency or hypoxia
10. Ongoing systemic infection
11. Contraindication to general anesthesia
12. Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure
13. Participation in any other study in last 30 days
14. Prior thoracic surgery on the same side of the lung as the SPN.
15. Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
16. Life expectancy of less than one year.
17. Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy
18. Prior radiation therapy treatment in the target lobe
A Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders of Consciousness

The research contains two parts. Part 1: To explore whether EEG responses to zolpidem can assess consciousness circuit integrity and predict the evolution of consciousness in patients with prolonged disorders of consciousness; Part 2: To explore if quantitative EEG reactivity might predict the prognosis of disorders of consciousness.


Eligibility Criteria:
Inclusion Criteria:

* presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission;
* time since onset \> 4 weeks;
* no history of neurodegenerative or psychiatric diseases.

Exclusion Criteria:

* allergic to zolpidem;
* currently receiving zolpidem or related benzodiazepines;
* diagnosed with seizure or status epilepticus.