cyrilzakka/clinical-trials huggingface dataset:
The Effect Of E-Mobıle Traınıng Gıven Postnatal Perıod On Postnatal Comfort And Breastfeedıng Self-Effıcıency

The period until the 42nd day after birth is called the postpartum period by the World Health Organization (WHO) Especially the first week of the postpartum period is the transition period both physiologically and psychologically, and the period when postpartum problems are at the highest level.This study was planned as a two-group control and e-mobile application in order to determine the effect of e-mobile training given in the postpartum period on postpartum comfort and breastfeeding self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

The ages of 18-35, Primiparous and multiparous pregnancy, Not clinical diagnosis of risky pregnancy, Able to understand and speak Turkish, Without communication difficulties and mental disabilities The mother and the baby have not developed any complications during pregnancy, delivery and postpartum period, Having a smart phone in the mobile application group, Those who have not attended childbirth preparation classes,

Exclusion Criteria:

* Preterm birth
* Postterm birth
Screening for Bleeding Disorders in Children

The investigators try to improve the screening of bleeding disorders in children by identifying symptoms, laboratory abnormalities and clinical scores discriminating patients congenital bleeding disorders in order to create a simple screening algorithm applicable in pediatrics, aiming for use in pre-anesthetic consultation and in consultation by pediatricians and general practitioners.

Objective : To determine simple clinical and biological factors that can improve the screening of hemostatic diseases at risk of hemorrhage in children.

Method:

* Retrospective inclusion of all patients \<18 years referred to the CRTH in pediatric consultation for the reason of exploration of a hemorrhagic syndrome or exploration of an anomaly in the hemostasis assessment.
* Data collected (by collection in the medical file):

Patient data: Age, sex, personal and family history of hemorrhagic disease

Clinical data: hemorrhagic symptomatology (epistaxis, gingivorrhagia, etc.) Biological data: PT, TCK, factor assay, platelet function Medical data: complete diagnosis if diagnosis of hemorrhagic disease

* Scores: HEMOSTOP, PBQ, ISTH, TOSETTO score
* Analyzes: calculation of the Odd Ratio, AUC, Se, Sp, VPP, VPN for different clinical / biological factors and each score.

Eligibility Criteria:
Inclusion criteria:

* referred by their general practitioner or another caring physician for evaluation of bleeding symptoms
* abnormal laboratory test results or family study
* the patient being the first-degree relative of a patient with a known bleeding disorder.

Exclusion criteria:

- older than 18 years old.
Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome

Gluten free diet (GFD) is now being tested in patients affected by schizophrenia, autism and multiple sclerosis, making GFD a possible therapeutic weapon not only for celiac disease or gluten sensitivity. In this protocol we investigate the effect of GFD in patients affected by burning mouth syndrome (BMS), a disease of unknown origin characterized by oral and especially tongue burning sensation, deeply decreasing the quality of life of patients


Eligibility Criteria:
Inclusion Criteria:

-Primary BMS

Exclusion Criteria:

* Celiac Disease
* Psychiatric Disorders
* intestinal autoimmune diseases
* Ongoing cancer
Roflumilast as add-on Therapy in Early Cases of ARDS

* Mild cases of ARDS will be included in a two-arm protocol, to receive 500 mcg of roflumilast daily up to 28 days (FDA approved dose for COPD) plus standard of care versus standard of care alone.
* Approximately 76 hospitalized patients with ARDS will be enrolled in this study.
* Eligible patients will be randomized at ratio of (1:1) to receive either roflumilast plus standard of care or standard of care alone.

• Methodology in details:

* Informed consent will be obtained from included participants.
* Mild cases of ARDS will be included in a two-arm protocol, to receive 500 mcg of roflumilast daily up to 28 days (FDA approved dose for COPD) plus standard of care versus standard of care alone.
* Approximately 76 hospitalized patients with ARDS will be enrolled in this study.
* Eligible patients will be randomized at ratio of (1:1) to receive either roflumilast plus standard of care or standard of care alone.
* Randomization:

Randomization will be in 1:1 ratio using permuted blocks of different sizes. Random.org website will be used for random selection of a sequence of blocks. The latter will be used to generate a randomized list which will be generated and stored by a third party independent of the study team. For allocation concealment, the list will be used to make sequentially numbered sealed opaque envelopes, each containing the sequential randomization number and allocation of subsequent cases. Envelopes will be handed to the study team member responsible for medication preparation. Each envelope will be opened only after:

1. Screening for eligibility
2. Obtaining consent
3. Recording baseline characters The treatment allocation dictated in the envelope will be documented in the case record form and will be subject to audit to assure correct randomization according to the original list.

   * Intervention:

Drug: Roflumilast

1. Roflumilast 500 mcg daily for up to 28 days
2. Total follow up time will be 28 days.
3. Proinflammatory parameters will be assessed at baseline, day 7, day 14, and at the end of treatment.
4. Roflumilast will be combined with standard of care for ARDS.
5. During hospitalization, clinical and laboratory data will be recorded daily in the medical history of the patient and in data collection table of the study.
6. During hospitalization, adverse drug reaction will be monitored clinically and by laboratory tests.
7. In case of an adverse effect or a need to discontinue the treatment, roflumilast should be suspended.

Eligibility Criteria:
Inclusion Criteria:

* Ability to sign informed consent
* Patients \>18 years old male or female
* Mild cases of ARDS according to the Berlin criteria (PaO/FiO 200 to 300 mmHg)

Exclusion Criteria:

* Pregnancy and breast feeding
* History of hypersensitivity to roflumilast
* Patients with mechanical respiratory assistance (severe ARDS)
* Patients under treatment with roflumilast for COPD
* Patients with psychiatric diseases
* Hepatic cirrhosis (Child-Pugh score B or C)
* Refused to sign informed consent
Prevalence of Occult HBV Infection Among Anti-HBc Alone Group in Northern Taiwan

Atni-HBs to HBsAg and Anit-HBc was interpreted based on three hepatitis markers for clinical detection of HBV-infections. HBAg and Anti-HBs were negative and the Anit-HBc-positive referred to as Anti-HBc alone. When the Anti-HBc alone occurs, patients may be due to mutations in HBV HBsAg can not be detected due to (1), but if by the molecular diagnostics by polymerase chain reaction (PCR) technology can detect HBV DNA present. When Anti-HBc alone in patients with serum HBV DNA can be measured, then there may be occult HBV infection. In different countries, Occult HBV infection in the Anti-HBc Alone group had significant differences in the prevalence (2.9 \~ 22.8%) (2), but prevalence survey in Taiwan there are very few studies on this , It is hoped to be able to investigation the prevalence of occult HBV infection Among Anti-HBc Alone.

The main use of this program, Taipei Medical University - Wan Fang Hospital in clinical specimens using the Roche system (Corbas e601) operating HBsAg, Anti-HBs, Anti-HBc to screen for the Anti-HBc alone group. Recycling Roche molecular system (Taq48) Real-time PCR to detect all anti-HBc alone population to understand their serum HBV-DNA viral load, in order to understand Occult HBV infection in the Anti-HBc alone group, the prevalence and viral load changes in these studies through the clinical units to provide occult HBV infection as a reference basis.

Eligibility Criteria:
Inclusion Criteria:

HBsAg(-)；Anti-HBs(-)；Anti-HBc(+)

Exclusion Criteria:

None
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.

OBJECTIVES: I. Determine the activity of cisplatin and vinorelbine in terms of response rate, duration of response, time to treatment failure, and survival in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix.

OUTLINE: This is a multicenter study. Patients receive vinorelbine IV over 6-10 minutes on days 1, 8, 15, and 22 and cisplatin IV over 4 hours beginning after completion of vinorelbine infusion on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within approximately 20 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven advanced, persistent, or recurrent squamous cell carcinoma of the cervix that failed local therapy and is considered incurable Bidimensionally measurable abdominal, pelvic, or other lesion by palpation, x- ray, or ultrasound If sole site of measurable disease previously irradiated, then documented disease progression at that site required

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Karnofsky 60%-100% Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 50 mL/min if creatinine greater than 1.2 mg/dL Other: No clinically significant infection No preexisting, clinically significant peripheral neuropathy unless due to cancer No other prior or concurrent malignancy except nonmelanomatous skin cancer No psychological, familial, sociological, or geographical condition that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except for radiosensitization Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Recovered from the toxic effects of any recent radiotherapy Surgery: Recovered from the toxic effects of any recent surgery
A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies

To establish the safety and efficacy of HTL0018318 compared with placebo when administered once daily for 12 weeks to patients with dementia with Lewy bodies.

To assess the safety, tolerability and efficacy of HTL0018318 at 3 dose levels (once daily) compared with placebo over a 12-week treatment period in patients with dementia with Lewy bodies (DLB). Approximately 140 DLB patients who have not received donepezil (Aricept®) and/or other acetyl cholinesterase inhibitors (AchEi) and approximately 32 DLB patients who have had prior treatment experience with donepezil but have stopped usage will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with probable DLB according to the fourth revision of consensus diagnostic criteria for DLB.
* Clinical imaging evidence from either SPECT or MIBG cardiac scintigraphy that is consistent with a clinical diagnosis of DLB.
* Partner or caregiver able to support the patient for the duration of the clinical trial.

Exclusion Criteria:

* Patients with a diagnosis of Parkinson disease at least 1 year prior to onset of dementia.
* Patients with the presence of severe extrapyramidal symptoms
* Patients with the presence of an illness/condition apart from DLB that could contribute to cognitive dysfunction
* Patients with poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy, who are currently on more than 2 different antihypertensive treatments
* Patients with prominent, recurrent episodes of syncope are related to orthostatic hypotension
* Patients with pulmonary disease or evidence of clinically significant moderate or severe pulmonary symptoms
* Patients who are taking a range of prohibited and restricted medication
* Patients who have been prescribed individualised cognitive rehabilitation, stimulation or training that was performed under medical supervision in the 6 months prior to the screening visit
* Patients who have any known condition(s) that may be contraindicated or interfere with the completion of the nuclear imaging scans.
Planned Semi-Elective Lung Tx Study

When suitable donor lungs become available for a consented recipient, and the donor cross clamp time occurs between 6pm and 4am, the transplant procedure (anesthesia starting time) will be allowed to be moved to a 6am start or later with the lungs being preserved at 10C cold static preservation upon organ arrival to our hospital using a specific refrigerator. The maximum allowed time between donor cross clamp and recipient anesthesia initiation will be 12h.


Eligibility Criteria:
Inclusion Criteria:

* Primary lung transplantation
* Informed consent provided

Donor Inclusion: Age\<70

Exclusion Criteria:

* Re-transplantation
* Multi-organ transplantation

Donor exclusion criteria:

* Age \>70y
* Concerns with organ preservation technique
Chronic Low Back Pain Randomized Controlled Trial

Chronic low back pain is a common condition that can negatively impact quality of life and that lacks highly effective treatment options. The YMCA developed different iterations of a stretching exercise program as a community based treatment for low back pain from 1974-2004. Though anecdotally successful, the YMCA stretching exercise program(s) was not scientifically evaluated for efficacy and became obsolete. The purpose of the study is to test the efficacy of a previously popular YMCA stretching exercise program(s) for back pain. The stretching exercise program that will be studied is a collection of all the resources available for the YMCA stretching exercise program(s). The most recent criteria from a National Institutes of Health sponsored Task Force to study chronic low back pain were applied to this study.

The study will employ a two arm parallel group stratified controlled trial. Statistics were prospectively formulated to compare outcomes of 60 people who completed the study, 30 participants in each intervention group. Subjects from 18 through 64 years old with low back pain on at least half the days over the previous 6 months will be recruited by the Wilton Family YMCA and New Canaan Community YMCA to participate in the study. The participants within each recruitment cohort will be randomized by a sub-investigator who is a statistician to the two treatment arms in a ratio of 1:1 (stretching exercise experimental arm: self-care book active comparator arm). Seven cohorts will receive the intervention stretching exercise program at the Wilton Family YMCA and New Canaan Community YMCA from January 2015 to December 2017. The stretching exercise program consists of 12 standardized weekly stretching exercise sessions that incrementally increase in duration from 15-30 minutes. Participants who receive the stretching exercise intervention will be asked to practice the identical stretches that they did in class on non-class days and will be given handouts and a companion CD to assist in this. Thirty control subjects will receive a self-care book. All analyses will be conducted assuming intent-to-treat principles using SAS statistical software. All P values and 95% CIs will be 2-sided with statistical significance at the P = 0.05 value.

Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 through 64 years old who have had low back pain on at least half the days over the previous 6 months

Exclusion Criteria:

* We will exclude persons whose back pain is attributed to systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis.
* Patients with complex conditions will not participate in the study (eg, sciatica, medicolegal issues, or a previous back surgery).
* We will also exclude persons who do not speak English.
* Finally, persons who are unable to attend classes or unwilling to do home practice will be excluded.
The Value of PET/CT in Diagnosing Residual Disease in Patients With Spinal Infection

MRI has shoved little correlation with the clinical finding during treatment of spondylodiscitis (infection in the vertebrae and/or discs). Since PET/CT is almost as good as MRI in diagnosing spondylodiscitis the hypothesis and this study is that PET/CT is better in predicting residual disease in patients with spondylodiscitis.

Preliminary study.

In the last years there has been reported increasing incidence of spondylodiscitis. The increase is mainly thought to be caused by the increasing elderly population and the increasing amount of spinal instrumentation in this population. The symptoms range from backache to severe neurological deficits. Up to 1/3 of cases are reported to be culture negative and cases can therefore be difficult to diagnose.

MRI is thought to be the main imaging technique to visualise infection. But with the increasing availability of 18-F FDG PET/CT, it is reported to be nearly as efficient to diagnose spinal infection.

During the long antibiotic treatment of spondylodiscitis, the clinicians have no real good imaging technique to predict residual disease since MRI during the remodelling fase of the spine will mimic no difference or worsening.

Since 18-F-FDG PET marks areas with a high amount of inflammatory cells it may also be faster in returning to normal images and therefore correlates better to actual status than MRI.

Some of the purposes of this study are therefore:

* To describe changes on PET/CT and MRI at index and after 4, 8 12 and 26 weeks and compare these to the clinical findings as well as inflammatory biomarkers.
* To investigate the correlation between normalisation of inflammatory biomarkers and changes on MRI and PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* first case of infectious spondylodiscitis
* MRI or 18-F-FDG PET/CT compatible with spondylodiscitis
* overall assessment compatible with spondylodiscitis

Exclusion Criteria:

* previous spinal infection (e.g. spondylodiscitis; epidural abscess)
* spinal operation in the previous 6 months
* spinal foreign body
* current malignant disease
Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Main Trial)

Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a randomized controlled trial to determine whether intermittent intensive insulin therapy is an effective therapeutic strategy that can preserve pancreatic beta-cell function and maintain glycemic control early in the course of type 2 diabetes.

In this study, eligible patients with type 2 diabetes will be randomized to either intermittent insulin therapy or not, on a background of metformin, after first undergoing a short course of intensive insulin therapy. The hypothesis under study is whether intermittent insulin therapy can preserve beta-cell function.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women between the ages of 30 and 80 years inclusive
2. T2DM diagnosed by a physician \</= 5 years prior to enrolment
3. Negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies
4. On either no anti-diabetic medication or on metformin monotherapy, with no change in dose/regimen within 4 weeks prior to enrolment
5. A1c at screening between 5.5% and 9.0% inclusive if on metformin, or between 6.0% and 9.5% inclusive if on no oral anti-diabetic medication
6. BMI \>/= 23 kg/m2
7. Negative pregnancy test at recruitment for all women with childbearing potential

Exclusion Criteria:

1. Current anti-diabetic treatment with insulin, sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 (GLP-1) agonist or dipeptidyl peptidase-4 inhibitor
2. Type 1 diabetes or secondary forms of diabetes
3. History of hypoglycemia unawareness or severe hypoglycemia requiring assistance
4. Any major illness with a life expectancy of \<5 years
5. Hypersensitivity to insulin, metformin or the formulations of these products
6. Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR) \<50 ml/min
7. Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, previous liver transplant) or transaminases \>2.5 X upper limit of normal
8. History of congestive heart failure
9. Excessive alcohol consumption, defined as \>14 alcoholic drinks per week for males and \>9 alcoholic drinks per week for females
10. Unwillingness to administer insulin therapy or perform capillary blood glucose monitoring at least 4 times per day while receiving IIT
11. Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study or the first 3 months after the study. Reliable contraception includes birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide.
12. Non-adherence to the induction phase or any factor likely to limit adherence to the study protocol, in the opinion of the investigator
A Prospective Trial Comparing the Cost of Post Operative X-rays for Fractures Treated With Stable Internal Fixation

The standard post-operative radiographic protocol for the monitoring of fractures at HSC includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. This is in addition to good quality intra-operative radiographs. With current operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal fixation. In fact, patients are often allowed to take weight through the fractured limb immediately post-operatively. In these cases, redundant post-operative radiographs likely represent an avoidable cost to the system financially, and an avoidable cost to the patient in additional time spent in hospital and unnecessary radiation exposure.


Eligibility Criteria:
Inclusion Criteria:

* Femur fracture treated with intramedullary nailing
* Tibia fracture treated with intramedullary nailing
* Ankle fractures treated with standard compression technique
* Humeral shaft fractures treated with standard compression technique
* Forearm fractures treated with standard compression technique
* One or both bones fractured
* Simple fracture or presence of single butterfly fragment treated with lag screw
* Clavicle fracture treated with standard compression technique
* Olecranon fracture treated with standard compression technique

Exclusion Criteria:

* Age \< 17 years, or open growth plates
* Multiple orthopaedic fractures
* History of radiographic appearance of osteoporosis or osteopenia or poor operative bone quality
* Likely difficult with follow-up in first 6 weeks
* Same day surgery case
* Surgeon feels patient should be excluded