cyrilzakka/clinical-trials huggingface dataset:
Cervical Length Pre-induction as a Tool to Predict Vaginal Birth

To evaluate the value of measuring cervical length as a predictor of vaginal birth after induction of labor with prostaglandins in pregnancies with 41 weeks of gestation.


Eligibility Criteria:
Inclusion Criteria:

* 41 weeks or more of gestational age
* Cervical length measured by a FMF certified physician

Exclusion Criteria:

* Any condition that could interfere with a possible vaginal birth (previous cesarean section, hypertensive disorders of pregnancies).
Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH

Study type :clinical trial Main purpose :esnsure safety and efficacy of Roflumilast to treat patients with Non-Alcoholic Steatohepatitis Background and aim: Non-alcoholic fatty liver disease is the most prevalent chronic liver disease globally. There is no defined therapy for non-alcholic steatohepatitis (NASH), therefore this study aimed at evaluating the efficacy and safety of Roflumilast in patients with non-alcoholic NASH.

Methods: This randomized controlled parallel study involved 55 patients with NASH who were randomized into vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily for three months.

Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of the homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Cytokeratine level \>240 IU/L.
* Adult patient (age \> 18 years old).
* Both sex.
* Overweight and obese.
* Patients with evidence of steatosis through imaging.
* Patient with mild to moderate elevation in aminotransferase activity (\>2 ,but \<5 times upper limit of normal ).
* Patient with Hepatic steatosis index (HSI) \> 36.
* Patient with HAIR ( hypertension ,alanine aminotransferase level ,insulin resistance ) of 2 or 3.
* Fibroscan score \>7Kpa and \< 12.5 Kpa (F2 - F3).

Exclusion Criteria:

* Alcohol consumer and smokers
* Patients with Wilson's disease and hemochromatosis .
* Patients with viral hepatitis.
* Patients with cirrhosis .
* Patients with inflammatory diseases .
* Patients with other comorbid disease that elevate transaminases (congestive heart failure and malignancy).
* Patients on medications that interfere with lipid and carbohydrate metabolism..
* Patients on stateogenic medications.
* Pregnancy and lactating women.
* Females on oral contraceptive pills.
An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice

The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).


Eligibility Criteria:
Key Inclusion Criteria:

* MS patients with any disease subtype who are ≥18 years of age and must have been newly prescribed Fampyra but not yet started the treatment.
* Patients who are willing and able to provide written informed consent.

Key Exclusion Criteria:

* None

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Determining the Impact of Shunting and CerebroVascular Reactivity on 7T MRI (DISCoVeR 7T MRI)

The purpose of this study is to use transcanial doppler (TCD) ultrasound to look for possible risk factors for ischemic brain injury. We will perform contrast TCD with agitated saline contrast to identify and contrast right-to-left shunt (RLS) and breath holding to assess cerebrovascular reactivity (CVR) in the elderly.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 60 years of age.
2. Fluent in English.
3. Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with consensus conference designation of cognitively normal, Mild Cognitive Impairment, or probable/possible Alzheimer's disease.
4. Has consented to participate in the ADCC high-resolution MRI sub-study.
5. NACC longitudinal visit must be within 6 months of the TCD study and brain MRI study.
6. Women: post-menopausal or surgically sterile.
7. Willing and able to complete all required study procedures.
8. Completed 6 grades of education.
9. Geriatric Depression scale less than 6 (assessed within 6 months at the NACC longitudinal visit).

Exclusion Criteria:

1. Prior clinically symptomatic ischemic or hemorrhagic stroke.
2. Inability to tolerate or contraindication to TCD study in the opinion of an investigator or treating physician.
3. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

To demonstrate the efficacy/safety of Fosamax Plus D


Eligibility Criteria:
Inclusion Criteria:

* Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
* Patient has been diagnosed with osteoporosis
* Patient has been postmenopausal for more than 6 months
* Patient has no contraindication to taking oral bisphosphonates
* Patient is eligible for dual energy x-ray absorptiometry in spine or hip

Exclusion Criteria:

* Patients with esophageal dysfunction
* Patients who can not sit or stand at least 30 minutes
* Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
* Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
* Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months
Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis

Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage liver diseases. However, the critical shortage of donor organs, high cost, and the problem of immune rejection limit its clinical application, and even some patients on the waiting list will never survive to receive a matched liver. Stem cell transplantation instead of conventional medical therapy or orthotopic liver transplantation will be a promising alternate approach to regenerate damaged hepatic mass. Adult mesenchymal stem cells (MSCs) are generally thought of as an autologous source of regenerative cells in previous studies.In this study, the safety and efficacy of menstrual blood-derived stem cells transplantation for patients with liver cirrhosis will be evaluated.

The purpose of this study is to show whether menstrual blood-derived stem cells can improve the disease conditions in patients with liver cirrhosis.

One of two treatment arms will be assigned to the patients. One group will receive 2 weeks of conventional therapy plus MenSCs treatment; The other group will receive 2 weeks of conventional therapy plus placebo treatment.

MenSCs will be cultured and collected in a GMP lab. Patients were strictly monitored after the cells injection via i.v.. Patients are followed up at intervals up to at least 2 years.Clinical parameters such as ascites volume,serum alanine aminotransferase,total bilirubin,prothrombin time,albumin,MELD score,and Child-Pugh score will be evaluated at each timepoint.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Aged 20 to 50years
* Liver cirrhosis
* Negative pregnancy test

Exclusion Criteria:

* Pregnant or lactating women
* Malignancies
* Sepsis
* Vital organs failure
* Severe bacteria infection
* Vascular thromboses in the portal or hepatic veins
Iron in Patients With Cardiovascular Disease

It is now recognized that iron deficiency in cardiovascular disease contributes to impaired clinical outcome.

The clinical trial is designed as a prospective, multi-centre, double-blind, randomised, controlled, interventional trial to investigate whether a therapy with i.v. iron (iron carboxymaltose) compared to saline can improve functional status across a subset of cardiovascular disease -namely acute myocardial infarction, atrial fibrillation, and heart failure with reduced ejection fraction.

Iron administration will be carried out according to summary of product characteristics. Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg iron carboxymaltose (over 15 minutes), except when haemoglobin is \> 16.0 g/dL or ferritin is \> 600 µg/L.

Eligibility Criteria:
Inclusion Criteria:

1. Cohort A (acute myocardial infarction): Acute Myocardial Infarction within 10 days (randomization/ first iron supplementation/ MRI must be performed within 10 days after AMI), without prior heart failure (defined as any known previous report of LVEF ≤ 45%) Cohort B (atrial fibrillation): Paroxysmal Atrial fibrillation or persistent AF Cohort C (heart failure): Left-ventricular ejection fraction ≤ 45 % (documented within the last 12 months prior to screening), all NYHA classes allowed
2. Confirmed presence of iron deficiency (ferritin \< 100 ng/mL or ferritin 100 - 299 ng/mL with transferrin saturation \< 20 %)
3. Haemoglobin ≤ 15.5 g/dL
4. Written informed consent

Exclusion Criteria:

1. Evidence of iron overload or disturbances in the utilisation of iron
2. History of severe asthma, eczema or other atopic allergy
3. History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
4. Use of renal replacement therapy
5. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 4 weeks prior to randomisation.
Aspirin and Enoxaparin for VTE in Trauma

The purpose of this study is to determine if the addition of antiplatelet therapy (i.e. aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of venous thromboembolism (VTE) in high-risk critically injured patients. The investigators further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and enoxaparin for decreasing the incidence of VTE after trauma.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Blunt or penetrating trauma
* Requires VTE thromboprophylaxis
* High-risk for VTE

Exclusion Criteria:

* Presence of VTE upon admission
* Pregnant or nursing
* Inability to give informed consent by patient or healthcare proxy
* Contraindication to enoxaparin
* Contraindication to aspirin
* Epidural or subdural hematoma
* Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or recent (within the last 12 hours) epidural or spinal anesthesia/procedures
The Effect of Education on Nurses' Knowledge About High-flow Nasal Cannula Oxygen Therapy

This study was conducted to evaluate the oxygen therapy methods used in pediatric services and to specify the roles and responsibilities of nurses in the application of HFNC, which is one of these methods. Although the decision to implement this treatment method is under the responsibility of the physician in Turkey, the use of the device, observing the effectiveness of the treatment, monitoring and recording the changes in the vital signs of the children are under the responsibility of the nurses shows the importance of the nursing perspective on HFNC.

High-flow nasal cannula oxygen therapy (HFNC) which meets the patient's ventilation need is a non-invasive ventilation system in which warmed and humidified oxygen is administered to the patient at varying flows with the help of a nasal cannula.This study will be conducted as a randomized controlled study with the participation of 70 nurses working in the pediatric clinics of a public hospital between December 2021 and May 2022, as an experimental group (n=35) and a control group (n=35). In the study, two-stage sampling method will be used to determine the nurses who will take place in the experimental and control groups. After the nurses are stratified according to their professional years, assignment to the experimental and control groups will be made by simple random sampling method. The experimental group will be given a pre-test before the training and a post-test one month after the training. In order to avoid interaction between the two groups, the data of the nurses in the control group will be collected first. The knowledge level of the nurses in the experimental and control groups will be evaluated with the HFNC Information Form.

Eligibility Criteria:
Inclusion Criteria:

* Nurses working in any of the pediatric emergency departments, pediatric clinics
* No previous training in HFNC treatment
* Follow-up of patients treated with HFNC
* Volunteering to participate in research

Exclusion Criteria:

* Those who have received in-service training on HFNC implementation
* Those who work as responsible nurses or training nurses in the clinics where the research will be conducted
Postoperative Folfox4 Only Versus Folfox4 Plus Transhepatic Arterial Chemotherapy (TAC) in the Treatment Unresectable Liver Metastasis of Colorectal Cancer

The purpose of this study is to investigate whether TAC plus FOLFOX4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.

We administered three cycles FOLFOX4 plus on TAC (oxaliplatin, FUDR and MMC) or FOLFOX4 only to primary colorectal tumor resected patients with unresected liver metastasis. The study endpoints were resection rate of liver metastasis, progression-free survival, overall survival as evaluated by intent-to-treat analysis.

Eligibility Criteria:
Inclusion Criteria:

* age \< 75 years with histologically proven adenocarcinoma of the colon or rectum
* no severe major organ dysfunction
* WHO performance status of 0 or 1
* no prior cancer therapy
* with measurable unresectableliver metastasis
* without other metastasis

Exclusion Criteria:

* age \>= 75
* severe major organ dysfunction
* WHO performance status of \>1
* prior cancer therapy
* with other metastasis
Effects Multimodal Mind and Body Approach for MCI

The aim of this application is to develop a computer-based multimodal mind and body approach (CMMBA) for mild cognitive impairment (MCI). This product will provide a new, cost-effective and easily accessible treatment option for MCI and potentially other age-related dementia.

The goal of this Phase I R41 (STTR) application is to develop a computer-based multimodal mind and body approach (cbMMBA) to improve the cognitive function for mild cognitive impairment (MCI). This application, if successful, will provide a cost-effective and easily accessible treatment option for MCI and other age-related dementia, significantly improve the prevention of MCI development, and directly benefit patients suffering from the highly prevalent disorder, particularly for those who may have limited access to in-person mind and body interventions.

Eligibility Criteria:
Inclusion Criteria:

1. report of cognitive decline / complaint by the patient, the patient's informant, or the physician;
2. cognitive impairment is confirmed by objective cognitive measures (Montreal Cognitive Assessment (MoCA) and neuropsychological testing), where objective cognitive impairment is defined as poor performance in one or more cognitive measures suggesting deficit in one or more cognitive domains;
3. patient has preserved independence in functional abilities (measured by informant report, completion of Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) checklists);
4. not demented;

Exclusion Criteria:

1. has severe visual or hearing impairment;
2. has pre-existing musculoskeletal or other conditions, which prohibit BDJ performance and / or the application of acupressure at the selected points;
3. has suffered from a neurological disorder (e.g., severe head trauma), psychiatric disease (e.g., major depression), or any other major medical disease that could potentially compromise their cognition;
4. has had prior experience with BDJ or acupressure or relaxation techniques in the past year.
Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis

In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and saline injection on pain, stiffness and physical function in patients with osteoarthritis.

Patients with osteoarthritis were randomly allocated into two groups. Group I (n=26) received intra-articular injection of 7 mL 0.5% lidocaine and Group II (n=26) received 7 mL saline into painful knee for 3 times with one week intervals under USG guidance. VAS and WOMAC scale including pain, stiffness and physical function was used for the assessment of patients with osteoarthritis. Analgesic requirements were also recorded.

The primary outcome parameter of this study was the pain scores. The sample size for the primary variable was calculated based on a standard deviation of 20 mm estimated from a previous study. A power analysis with a type II error of 20% at a two-sided 5% significance level estimated 22 patients per group to be included. Investigators included 26 patients per groups for possible missing date. χ2 test for categorical data and independent samples t-test for the comparison of VAS and WOMAC scores between groups were used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* knee pain for more than 25 of the past 30 days, morning stiffness or less than 30 minutes, crepitation in the knee
* pain for more than 25 of the past 30 days and osteophytes on x-ray examination of the knees indicating knee OA

Exclusion Criteria:

* the knees with a history of mechanical derangement, fibromyalgia, skin lesions and other risk factors of infection, therapy with anticoagulants and trauma/surgery
Voiding Log and Fluid Intake Habits

Health practitioners usually instruct patients with complaints of urinary incontinence and urinary tract infection regarding voiding and fluid intake habits. However poor drinking habits develop early in life, even prior to the symptoms presentation. Little is known about the voiding habits and fluid intake routine among healthy young population. The current study aims to assess the habits of drinking and voiding log among such population.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female Adolescent healthy population

Exclusion Criteria:

* History of incontinence Symptoms of urinary tract infection History of any pelvic floor disorder
Nutritional Risk Screening Nutritional Support Gastrointestinal Cancer

The goal of this clinical trial was to compare the effects of different nutritional support methods based on nutritional risk screening on postoperative nutritional status in patients with gastrointestinal tumors.The main question it aims to answer is that different types of nutrition can improve the nutritional status of patients with different nutritional status;Long-term dietary interventions for patients with poor nutrition can make cancer patients better able to tolerate surgery and chemotherapy and improve their quality of life.The intervention group received nutrition + exercise + psychological intervention upon admission, routine parenteral and enteral nutrition support after operation, and continued nutrition + exercise + psychological intervention after discharge.The control group received routine parenteral nutrition support in the department after surgery, and the patients and their families were given diet education during hospitalization.

Purpose: The investigators conducted nutritional risk screening for patients with gastrointestinal tumors, gave different nutritional support methods to patients with different nutritional status, and analyzed the changes of various nutritional indexes of patients before and after nutritional intervention.

Methods: A total of 302 patients with gastrointestinal tumors admitted to the First Hospital of Shanxi Medical University from July 2021 to June 2023 were selected.All patients underwent nutritional risk screening after admission and were divided into intervention group (NRS2002≥3 and PG=SGA≥4, n=204) and control group (NRS2002 \< 3 or PG=SGA \< 4 , n=98) according to the screening results.Different nutritional interventions were given to analyze the changes of NRS-2002 and PG-SGA scores between the two groups before and after propensity score matching, and compare the changes of dietary energy, dietary protein, total energy, total protein, body mass index (BMI), fat-free weight, walking time, grip strength and other nutritional indicators (hemoglobin, albumin, prealbumin) between the two groups.The effects of disease type and age on the results were compared by stratified analysis.

Eligibility Criteria:
* Inclusion Criteria:

  1. Age ≥ 18 years；
  2. The first pathological diagnosis was gastric or colorectal cancer and radical resection of malignant tumor was performed；
  3. Conscious, able to read, write and understand the study；
  4. Sign informed consent and participate in this study voluntarily.
* Exclusion Criteria:

  1. Patients with malignant tumors at other sites；
  2. Patients undergoing neoadjuvant chemotherapy before surgery；
  3. Anastomotic fistula, anastomotic obstruction, gastroparesis and other serious complications occurred after operation；
  4. There are mental disorders, psychological disorders；
  5. Patients who did not cooperate to complete the full intervention or follow-up records were missing；
  6. Patients with missing baseline data and nutritional risk screening results.