cyrilzakka/clinical-trials huggingface dataset:
Risk of Cardiovascular Events in Patients With Type 2 Diabetes Initiating Oral Antidiabetic Treatments

The purpose of this study is to compare the incidence of major cardiovascular events among patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new initiators of oral anti-diabetic drugs (OADs)in classes other than Dipeptidyl peptidase IV (DPP4) inhibitors.

Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Newly prescribed Saxagliptin or an OAD in a class other than DPP4 inhibitors
* Enrolled in the respective database for at least 180 days prior to the first prescription for Saxagliptin or other OAD in a class other than DPP4 inhibitors

Exclusion Criteria:

* Patients identified with a diagnostic code for any of the cardiovascular outcomes of interest within the 180-day baseline period
* Patients prescribed a DPP4 inhibitor during the baseline period
CT Diagnoses in Crohn"s Disease Activity

The study focused on the clinical value of CT in assessing the activity of Crohn's disease.

"Crohn's disease is an inflammatory disease with non-specific clinical manifestations. The lesions are more common in the ileocecal area and the end of the ileum, and also can affect the entire digestive tract. In recent years, the domestic incidence of Crohn's disease has been increasing. At present, CT diagnosis still lacks the gold standard and requirescombination of clinical manifestations, endoscopic examination, imaging examination and laboratory examination results. CT has showed advantages of non-invasive inspection, fast imaging speed, high tissue density resolution, and strong patient acceptability. In addition, the examination can clearly show the internal and external tissue structure of the digestive tract, which has been widely used in the diagnosis and activity evaluation of Crohn's disease.

In order to clarify the clinical value of CT in assessing the activity of Crohn's disease, this study mainly used retrospective analysis of the CT manifestations and clinical data of patients with Crohn's disease to explore the clinical value of CT in assessing the activity of patients with Crohn's disease."

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease patients with confirmed endoscopic or pathological examination results
* Complete laboratory data such as CRP, erythrocyte sedimentation rate, etc.

Exclusion Criteria:

* Related inspection results are not complete
* The interval between endoscopic and laboratory examination results exceeds 2 months
Comparing the Quality of Life Between LADG and TLDG for Gastric Cancer_KLASS07 (CKLASS01)).

The present randomized study is designed to compare the quality of life between the patients undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy to laparoscopy-assisted distal gastrectomy.

The primary endpoint of this trial is the early postoperative morbidity, that is defined as complications that occur within 30 days after surgery.

Early postoperative morbidity is classified as follows:

(1) wound morbidity (2) surgical site morbidity: anastomosis bleeding or leakage, duodenal stump leakage, postoperative bleeding, afferent loop or efferent loop obstruction, etc.; (3) lung morbidity: atelectasis, pleural effusion, empyema, pneumothorax, etc.; (4) intestinal obstruction morbidity (5) urinary tract morbidity (6) intra-abadominal abscess (7) postoperative pancreatitis (8) pancreatic fistula (9) intestinal fistula 10) others: lymphorrhea, diarrhea, etc.

The secondary end point is the questionnaire score regarding QOL. This is assessed by the Korean versions of the EORTC QLQ-C30 (version 3.0) and STO22 questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Histologic proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
* Age between 20 and 80 years old
* Eastern Cooperative Oncology Group performance statu of 0 or 1
* Clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the American Joint Committee on Cancer system10 (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
* Scheduled for laparoscopic distal gastrectomy with D1+ or D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2010 (ver.3).)
* Patients who gave a consent and signed the formal paper permitted by Institutional Review Board (IRB) after hearing a full description of the study (purpose and contents) prior to the participation

Exclusion Criteria:

* Patients who received stomach surgery (i.e. gastrectomy or gastrojejunostomy) in the past
* Patients with intraabdominal adhesion due to previous intraperitoneal surgery
* Patients who recently diagnosed with gastric cancer and received either anticancer treatment or radiation therapy
* Patients who requires combined organ resection due to aggression of gastric cancer or other diseases
* Patients who received surgeries due to primary cancer of other organs, or had anticancer treatment or radiation therapy in the last five years (patients whose skin basal cell carcinoma and insitu cervical cancer are completely cured are exceptions).
* Vulnerable people who can't communicate or are pregnant (or planning to be pregnant)
* Patients who are currently participating or participated in other clinical trials in the last six months.
Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy

The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.

The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.

Eligibility Criteria:
Inclusion Criteria:

* Between age 18 and 70 years
* Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.

Exclusion Criteria:

* Evidence of skin conditions other than psoriasis
* Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or disease-modifying antirheumatic drugs (DMARD) with 28 days of screening
* ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin
* Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
* Corticosteroid dose of prednisone \>10 mg/day
* Serious infection
* Receipt of any live vaccine
* Abnormal hematology or chemistry
* Body mass index (BMI) \> 38
* Pregnancy or Breastfeeding
* Significant concurrent medical conditions
Well-Being and Health-Related Quality of Life in Melanoma Patients During COVID-19 Pandemic

The primary purpose of this study is to gain an understanding of how experiences during the COVID-19 pandemic, regardless of COVID-19 status, may have impacted multiple domains of health-related quality of life and other areas such as COVID-19 specific psychological distress, and disruptions to health care, finances and social interactions. We will also evaluate the extent to which resiliency factors such as social support, perceived benefits under times of stress, and ability to manage stress may buffer associations between COVID-19 experiences and HRQoL. To meet these objectives, we have developed a 10-minute questionnaire that taps into these areas and is based on prior work addressing concerns of other pandemics or national crises. Participants will have previously consented to protocol PA15-0336 and have provided prior lifestyle data. This will allow us to connect the COVID-19 survey data with prior existing data.

PRIMARY OBJECTIVES:

I. Assess experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends); COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms); health, financial and social disruptions; perceived benefits and social support; and health-related quality of life (HRQoL) in melanoma patients who participated in protocol PA15-0336.

II. Evaluate the extent to which COVID-19 experiences are associated with COVID-19-specific psychological distress, health, financial and social disruptions, perceived benefits and social support, and HRQoL.

III. Evaluate the extent to which resiliency factors such as social support and perceived benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL.

IV. Explore the association between prior lifestyle data collected as part of PA15-0336 and COVID-19-specific psychological distress and HRQoL.

OUTLINE:

Patients complete a survey over 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have signed consent for PA15-0336
* Has an active email address and can be contacted via MyChart
* Documentation of being alive per the cancer registry
Transcranial Alternating Current Stimulation

To investigate the efficacy of using transcranial alternating current stimulation (tACS) to enhance the regaining of neurological function among post-stroke patients.

Sixty post-stroke patients were randomly assigned to receive 15 sessions of the usual rehabilitation programme with or without tACS. The NIH Stroke Scale (NIHSS) and the mean blood flow velocity (MFV) and Gosling pulsatility index (PI) captured for the middle, anterior, and posterior cerebral artery were the outcome measures.

Fifteen 30-minute sessions of tACS appear to be effective for enhancing post-stroke patients' neurological function. The haemodynamic measures taken indicated that the regaining of function among the patients was largely attributed to a lowering of the vascular autoregulatory activity together with an increase in blood flow velocity at the middle cerebral artery. Future studies should explore the underlying mechanisms mediating the positive effects brought about by tACS in post-stroke rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as first onset intracerebral haemorrhage or infarction (according to ICD-10 I61.0-I61.6 or I63.3-I63.6, with or without I69, i.e.: sequelae of cerebrovascular disease)
* between 15 and 60 days after the onset
* right handedness
* no previous neurological or psychiatric disorders
* positive transtemporal windows for bilateral middle, anterior, and posterior cerebral arteries insonation (according to the standards set by the Transcranial Doppler Ultrasonographic Device (TCD))
* NIH Stroke Scale (NIHSS) scores between 14 and 24
* not receiving rehabilitation before admission

Exclusion Criteria:

* medical comorbidity preventing the patient undergoing the intervention
* preceding epileptic fits
* having metallic implants in the brain or a pacemaker
* history of surgery to the brain
Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content

This study is designed to demonstrate that cherry juice is effective in treating insomnia, and to show that it works by inhibiting an enzyme that will be measured in the blood.

This study will consist of 4 visits - 1 screening visit and 3 treatment visits. Screening visit will consist of a fasting chemistry panel, a health questionnaire, an Insomnia Severity Index, the Epworth Sleepiness Scale, the Pittsburgh Sleep Quality Index, the Beck Depression Inventory, the State-Trait Anxiety Inventory, and the Fatigue Severity Scale.

Ten subjects passing screening will take for 2 weeks between dinner and bedtime in a blinded and balanced order: 1. Eight ounces of cherry juice standardized to its proanthocyanidin content in the morning and 8 ounces of cherry juice standardized to its procyanidin content 1-2 hours before bedtime for 14 days; 2. A similar amount of placebo juice with the same timing for the cross-over. There will be a 2-week washout between each of the treatment periods. Subjects will be scheduled for two overnight PSGs, one at the end of each two-week treatment period. On the morning following each test the insomnia severity index and other questionnaires will be repeated. The order of the placebo juice and cherry juice will be random and balanced.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female with a usual bedtime between 9 pm and midnight.
* 65 years of age or older.
* Sleep problem \>3 nights per week, meeting the International Classification of Sleep Disorders (ICSD-2\*) diagnostic criteria of insomnia for at least 6 months.
* An insomnia severity index ≥ 10 and a minimum of 30 minutes of either sleep-onset latency (SL) or wake after sleep onset (WASO).

  \*ICSD-2 general criteria for insomnia:
* A complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early, or sleep that is chronically non-restorative or poor in quality.
* The above sleep difficulty occurs despite adequate opportunity and circumstances for sleep.
* At least one of the following forms of daytime impairment related to the nighttime sleep difficulty is reported by the patient:
* Fatigue or malaise.
* Attention, concentration, or memory impairment.
* Social or vocational dysfunction or poor school performance.
* Mood disturbance or irritability.
* Daytime sleepiness.
* Motivation, energy, or initiative reduction.
* Proneness for errors or accidents at work or while driving.
* Tension, headaches, or gastrointestinal symptoms in response to sleep loss.
* Concerns or worries about sleep.

Exclusion Criteria:

* Diabetes.
* Sedating or hypnotic medications.
* Any chronic medication that has not had a stable dose for 1 month or longer.
Efficacy Study of Outpatient Therapy for Lymphoma

This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.

Lymphoma has been increasing in incidence annually for the past several decades and the majority of patients relapse after first line therapy. A variety of 'salvage chemotherapy' treatments are available that are usually inpatient-based treatments associated with significant haematological toxicity. Furthermore, all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done. During 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs, vinorelbine and gemcitabine. Over 75% of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls. We now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features, that is, patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
* ECOG 0 - 2
* written informed consent

Exclusion criteria:

* Intention to proceed with any form of transplant therapy following fewer than 2 cycles of protocol salvage therapy
* bilirubin \> 50μmol/litre unless secondary to lymphoma
* creatinine \> 2 x upper limit of normal unless secondary to lymphoma, absolute neutrophil count \<0.5 x 109/litre and / or platelets \< 50 x 109/litre unless secondary to lymphoma
* relapse within 6 months of a prior transplant procedure (autologous or allogeneic)
* known sensitivity to E coli derived preparations
Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy

Hysterectomy is one of the most commonly performed gynecologic surgeries in the USA. It is used for many benign conditions such as leiomyoma and abnormal uterine bleeding. Surgery may involve the removal of the cervix (total hysterectomy, TH) or its preservation (supracervical or subtotal hysterectomy, SH). Whether TH or SH is the best procedure for benign conditions is a matter of debate. Considering the lack of evidence, this study aims to evaluate long-term sexual dysfunctions, urinary dysfunctions and pelvic organ prolapse in women who underwent laparoscopic subtotal versus total hysterectomy for benign conditions.


Eligibility Criteria:
Inclusion Criteria:

* Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions.

Exclusion Criteria:

* Women with gynecological and non-gynecological cancers.
Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed

To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Female/male aged 18 years and over
3. History of edentulism in the study area of at least 3 months
4. In need for implant(s) replacing missing tooth/teeth in the maxilla
5. Deemed by the investigator to be suitable for one stage surgery
6. Deemed by the investigator to be suitable for loading after 10-12 weeks
7. Deemed by the investigator as likely to present an initially stable implant situation.
8. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.

Exclusion criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator
2. Uncontrolled pathological processes in the oral cavity
3. Known or suspected current malignancy
4. History of radiation therapy in the head and neck region
5. History of chemotherapy within 5 years prior to surgery
6. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
7. Uncontrolled diabetes mellitus
8. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
9. Present alcohol and/or drug abuse
10. Current need for bone grafting and/or augmentation in the planned implant area
11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
12. Previous enrolment in the present study.
13. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.
An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection

This study is being conducted to assess the safety and tolerability of an oral liquid solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected children between the ages 3-16 who are failing or intolerant of current antiretroviral regimen and who are unable to swallow Sustiva capsules.


Eligibility Criteria:
Inclusion Criteria:

* Children 3-16 years of age
* Anti-retroviral naive or experienced
* Failing or intolerant to current Anti-retroviral regimen
* Limited available viable therapeutic options
* Inability to take capsules/tablets

Exclusion Criteria:

* Less than 10kg
* Failure on or concomitant use of other NNRTIs
* An active AIDS-defining opportunistic infection or disease
* More than two episodes of moderate to severe diarrhea or vomiting lasting more than four days within the past three months
Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members

Grand Hôpital de Charleroi (GHdC) had to organize the vaccination of its staff in December 2021 against SARS-CoV-2.On the sidelines of this vaccination campaign, the management committee agreed to document the knowledge of the SARS-CoV-2 serology of all the staff of the establishment before this vaccination campaign, as well as a few weeks after vaccination.

In November 2021, the Belgian government decided to offer a third dose of vaccine against SARS-CoV-2 virus. The GHdC managment committee has agreed to continue monitoring SARS-CoV-2 serology for members who receive their third dose of vaccine.

Grand Hôpital de Charleroi (GHdC) staff were exposed to the risk of SARS-CoV-2 infection during the first half of 2020: a seroprevalence survey, conducted in the summer of 2020, after the "first wave" of the epidemic, and before the "second wave", thus revealed a significant seroprevalence because of its exposure. This study, because of its high participation rate, also showed the sustained interest of the agents in knowing their serology, either for personal reasons, or for the purposes of recognition as an occupational disease.

The GHdC decided in December 2020 to organize as soon as possible the vaccination of its salaried and self-employed employees who wish to take advantage of this opportunity. On the sidelines of this vaccination campaign, the management committee agreed to document the knowledge of the SARS-Cov-2 serology of all the staff of the establishment before this vaccination campaign, as well as a few weeks after vaccination. This knowledge must better organize the disease prevention strategy, both with regard to the staff themselves and the patients for whom they are called upon to treat.

When the Belgian government decided in November 2021 to offer a third dose of vaccine and start it up in hospitals, the GHdC managment committee has agreed to continue monitoring SARS-CoV-2 serology for members who agree to receive their third dose of vaccine.

Eligibility Criteria:
Inclusion Criteria:

* To be an employee or independent collaborator at the GHdC

Exclusion Criteria:

* Refusal to take a blood test for anti-SARS-CoV-2 antibodies

Regarding amendment 1:

* Members who did not receive the third dose of PFIZER vaccine (Comirnaty) during the GHdC vaccination campaign and who did not performed a blood test to measure anti-SARS-CoV-2 antibodies.