cyrilzakka/clinical-trials huggingface dataset:
A Research Study Examining the Use of Olanzapine for the Prevention of Migraine

Olanzapine (o-lan-zah-peen) is a medication that has been approved by the Food and Drug Administration (FDA) for the treatment of patients with schizophrenia and/ or bipolar disorder. The trade name for this drug is Zyprexa®. Olanzapine has not been approved by the FDA for the prevention of migraine and is experimental for the purposes of this research study.

The Jefferson Headache Center at Thomas Jefferson University has developed this clinical study to evaluate the safety and effectiveness of Olanzapine in preventing migraine headaches.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are male or female between the ages of 18 and 65, inclusive
* Subjects who have a history of migraine with or without aura as defined by IHS criteria, for at least one year prior to screening
* Subjects who experience between 3 and 10 migraine attacks per month, for the three months preceding screening
* Subjects who have no more than 15 headache days per month
* Subjects who have been on a stable dose (no clinically significant changes) of all daily medications, for any indication, from 28 days prior to screening through the duration of the trial.
* Women who are using, or agree to use for the duration of the study, a medically acceptable form of contraception (as determined by the investigator), if female of childbearing potential.
* Subjects who are able to understand and comply with all study requirements
* Subjects who provide written informed consent prior to any study procedures being performed.

Exclusion Criteria:

* Women who are pregnant or lactating
* Subjects with an abnormal ECG that, in the investigators opinion, would expose them to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability (subjects with QTC interval greater than 450ms will be excluded)
* Subjects currently taking, or have taken within the thirty days prior to screening, any neuroleptics \> 1 day per week (such as Geodon, Zyprexa, Compazine, Phenergan, Seroquel and other drugs in the same class)
* Subjects currently taking or have taken within 4-weeks prior to screening any medication for the prevention of migraine
* Subjects who have failed more than two adequate trials of migraine prophylaxis, as determined by investigator
* Subjects who experience significant orthostatic hypotension, as determined by the investigator
* Subjects who, in the investigators opinion, have a history or have evidence of a medical condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
* Subjects who, in the investigators opinion, have a history or have evidence of a psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial.
* Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
Information for Patient Controlled Analgesia Device

This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device

Postoperative pain is still a challenge for anesthesiologist. Patient controlled analgesia is an effective method for postoperative pain management. However, most of the patient can not use the device properly. The important cause of inabilities about device usage is insufficient information.In the patient information, visual, oral or written communication methods can be chosen. However, which method is suitable for our patient group is not clear.This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* Elective hysterectomy

Exclusion Criteria:

* Opioid abuse or Chronic opioid usage
* opioid allergy
* obesity(BMI\>30)
* psychiatric disease
* more than American Anesthesiologist Score 2
TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients.

This study aims at analyzing the therapeutic activity of TPO-mimetics Eltrombopag and Romiplostim as bridge therapy for splenectomy in adult patients with primary immune thrombocytopenia.

Adult immune primary thrombocytopenia is an autoimmune malignancy characterized by platelet destruction and inadequate platelet production. Its incidence is of three cases per 100,000 people a year, with a prevalence in women in young and older adults.

Splenectomy is, still today, the therapeutic approach that offers a bigger guarantee of a long term response (around 60+70%). Nevertheless, splenectomy may be accompanied by peri-operative complications in almost 10% of patients, which in rare cases may be fatal. These are normally hemorrhagic complications due to low platelet count. Thus, a previous therapy to increase platelets is advisable before any splenectomy.

In patients who are refractory to corticosteroids and immunoglobulins or when its use is not indicated, splenectomy has a potential risk of more complications. Since the last few years, we count with TPO-mimetic drugs, specific for c-MPL receptor, able to stimulate platelet production, such as romiplostim and eltrombopag.

Nowadays, TPO-mimetics are allowed in Italy when patients refuse splenectomy or when splenectomy is not contraindicated, but being ITP with a low platelet count (\< 20-50.000/mmc) a potential contraindication to splenectomy due to hemorrhagic events, these drugs should be considered. Nevertheless, there are no data on therapeutic risks and safety of these agents when used for this indication. The aim of the present study is to verify, on an Italian national scale, the frequency of use, its impact and the safety profile.

Eligibility Criteria:
Inclusion Criteria:

* Persistent or chronic ITP in symtomatic phase.
* 18 years of age or older.
* Indication for splenectomy due to refractory response to a previous therapy.
* Have used eltrombopag or romiplostim to increase platelet count before splenectomy.
* Have undergone splenectomy.

Exclusion Criteria:

* No informed consent.
Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy

Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to predict pancreatic fistula using the C-reactive protein-albumin ratio (CAR). The total number of participants expected to be included in this research comprises patients who underwent PD between 2017 and 2023 and developed pancreatic fistula. The participants invitation is based on the detection of a pancreatic fistula. This study is conducted for research purposes and participation is voluntary. No interventions will be performed on the participants as part of this study; however, we have prepared this form to obtain participant permission to gather certain information. If the participants consent to the use of information for scientific purposes with the guarantee of confidentiality, they will be asked to sign a consent form.

Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality rates. Despite dramatic advancements in surgical techniques and perioperative management, reported morbidity and mortality rates following PD are 41.56% and 2.88%, respectively, which remain unsatisfactory. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. Therefore, accurate and timely prediction of POPF after PD is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions. The C-reactive protein-albumin ratio (CAR) is an inflammatory marker calculated by dividing serum CRP levels by albumin levels and has been associated with poor prognosis in sepsis patients. This study aimed to investigate the predictive significance of CAR for POPF.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 80 years
* Diagnosed with pancreatic cancer
* Patients without recurrence

Exclusion Criteria:

* Patients who underwent total pancreatectomy
* Data were not available
* Patients outside the specified age range
Changes in the Risk Factors of Coronary Heart Disease Observed After Scaling and Root Planing

The purpose of this study is to determine whether scaling and root planing as a periodontal intervention helps in improving the overall health of patients suffering from coronary heart disease.

This study is a randomized, outcome assessor blinded, parallel group, trial to evaluate the effect of non surgical periodontal treatment in the form of scaling and root planing on coronary heart disease patients. 70 clinically defined coronary heart disease (CHD) patients with mild to moderate periodontitis, were allocated into two groups- experimental and control, in a ratio of 1:1. Scaling and root planing was provided as the intervention to the experimental group. To the control group no periodontal intervention in any form was provided. The primary outcome assessed is the changes in C-reactive protein level at baseline and after 1, 3, and 6 months of periodontal intervention. The secondary outcomes assessed are lipid profile, white blood cells (WBC) profile, and blood pressure (systolic and diastolic) at baseline and after 1, 3, and 6 months of periodontal intervention. Periodontal parameters including plaque index (PI), gingival index (GI), bleeding on probing (BOP), periodontal probing depth (PPD), and clinical attachment loss (CAL) is also assessed at baseline and after 6 months. All these parameters were also compared with their corresponding values in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Male and female \> 35 yrs of age
* Clinically diagnosed stable CHD cases
* No other systemic disease
* Non-smoker
* Advanced chronic gingivitis and mild to moderate chronic periodontitis (≥ 4 teeth with probing depth ≤ 5 mm) and ≥ 14 teeth (excluding third molars)
* No periodontal therapy in the last 12 months.

Exclusion Criteria:

* Not fulfilling criteria of the defined CHD case
* Present smoker
* Pregnant or lactating females
* Suffering from any other systemic disease like diabetes
* Taking systemic antibiotic therapy in the last 3 months
* Advanced chronic periodontitis (probing depth \> 5mm) and \<14 teeth (excluding third molars)
* Received any periodontal therapy within last 12 months.
A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.

This is an open-label follow up study to evaluate the efficacy and safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial (ALLO-ASC-EB-101) for 24 months.

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Dystrophic Epidermolysis Bullosa.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101.
2. A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.
rTMS Treatment of Persistent Headache and Post Concussion Symptoms Attributed to Mild Traumatic Injury to the Head

The objective of this study is to investigate the treatment effect of repetitive transcranial magnetic stimulation in patients with a history of both persistent post-traumatic headache and post-concussion symptoms. In this double-blind, sham-controlled, concealed allocation, randomized clinical trial, 20 patients aged 18-65 yrs will be recruited from the Calgary Brain Injury Program (CBIP) and the Calgary Headache Assessment and Management Program (CHAMP) / Calgary Chronic Pain Centre, Calgary, Alberta, Canada. Patients will engage in a two-week rTMS treatment protocol (10 treatments) and will be followed for 6 months after therapy.

Demographic information will be collected two weeks prior to starting the study including age, sex, education, headache history, concussion history, past medical history, medication use, and family medical history. Headache history will be collected including frequency, severity, medication-use, type of headache, associated symptoms (i.e. neck pain, photophobia, phonophobia, nausea, vomiting) and headache triggers. Baseline questionnaires will be completed including headache intensity scale - 6 (HIT-6), Rivermead PPCS questionnaire, British Columbia post-concussion symptom inventory (BC-PSI), Montreal cognitive assessment (MoCA), quality of life after brain injury questionnaire (QOLIBRI), patient health questionnaire-9 (PHQ-9), generalized anxiety disorder scale-7 (GADS-7) and the post traumatic stress disorder checklist for DSM-5 (PCL-5). Patients will keep a two-week baseline headache diary before treatment, 2 weeks during treatment, 2 weeks following rTMS, and for 2 weeks at the 1, 3, and 6 month follow up assessments (total of 12 weeks). Patients will be reassessed at the completion of their rTMS treatment (day 14), and at 1, 3, and 6 months post-treatment. The questionnaires including: HIT-6, Rivermead PPCS questionnaire, PC-PSI, QOLIBRI, PHQ-9 and GAD-7 will be completed at all follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a persistent headache attributed to traumatic injury to the head based on the ICHD-3 criteria
* Diagnosis of persistent post-concussion symptoms based on the ICD-10 criteria
* mTBI occurrence from 3 months to 5 years from study start date

Exclusion Criteria:

* Prior history of TMS therapy
* TMS-related contraindications (pacemaker, metallic implant)
* History of chronic headache (\>15 days/month for 3 months) or migraine prior to most recent trauma
* Other medical conditions such as: structural brain disease, previous seizure, psychotic disorders (schizophrenia, bipolar disorder), liver or kidney disease, malignancy, uncontrolled hypertension or diabetes, and pregnancy
The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment

Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.

It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.


Eligibility Criteria:
Inclusion Criteria:

* At risk of pressure ulcer development based on a Braden score ≤ 17 or pressure ulcer category III or IV
* Bedbound or chair bound
* Aged ≥ 65

Exclusion Criteria:

* Short-stay residents (expected length of stay ≤14 days)
* End of life care
* Medical contraindication for patient repositioning/turning
Child Care Wellness Study on Nutrition and Physical Activity

The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.

The broad, long term goal is to develop a reproducible nutrition and physical activity intervention which utilizes child care consultant nutrition specialists to reduce the risk of overweight among children in regulated out-of-home child care. The objectives are:

1. To train Child Care Health consultants (CCHCs) to become specialists in nutrition consultation in child care such that they will increase their daily consultation activities on nutrition, physical activity, and childhood overweight,
2. To increase child care staff and parental knowledge of and positive attitudes toward providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers.,
3. To strengthen child care center policies, procedures, practices and behaviors, regarding providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers, and
4. To improve dietary intake and levels of physical activity, and to prevent increases in overweight and the risk of overweight as determined by body mass indexes among children in out-of-home child care centers.

Eligibility Criteria:
Inclusion Criteria:

* In each of the three geographical areas (NC, CA, CT), two pairs of community-based child care centers in urban areas with English-speaking directors, kitchens, and with 50-60 children between the ages of 2 and 5 years, 35% of whom are eligible for subsidy.

Exclusion Criteria:

* If the randomly selected child care center has an open case of child abuse or neglect.
Effect of HBM Based Education on Glycemic Control of Type 2 Diabates Patients

This pre-post-test randomized controlled (parallel group) experimental design study aimed to determine the effect of education based on health belief model and health literacy level of patients with type 2 diabetes on disease management. Study was carried out in Isparta Davraz Family Health Centre between June 17, 2019 and March 02, 2020. Sample consisted of 120 patients with type 2 diabetes, selected by simple randomization method, including 60 patients for the intervention group and 60 patients for the control group.

Patients in intervention and control were also sub-grouped according to their health literacy level. The intervention group was given training based on the health belief model with groups of 10-12-13 people every week for 6 weeks in the Family Health Center, followed by telephone counseling in the following 6 weeks and follow-up for 12 weeks. Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research. "Patient Data Form", "Health Literacy Scale Among Diabetes Patients", "Health Belief Model Scale in Diabetes Patients" and "Type 2 Diabetes Self-Efficacy Scale" used for data collection. Data were collected both on the first day of the study and in the 24th week.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 Diabates Mellitus at least for a year
* Literate

Exclusion Criteria:

* Problems with vision and hearing
Transvaginal Ultrasound As Predictors of Successful Induction of Labour

To compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.

The aim of this prospective study is to compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous or multipara
* Singleton live pregnancy
* Gestational age between 37 - 42 weeks
* Cephalic presentation
* Intact membranes
* Reactive cardiotocograph tracing
* Low risk pregnancy

Exclusion Criteria:

* Previous history of uterine surgery
* Low lying placenta, placenta praevia and vaginal bleeding
* Multiple pregnancy
* Preterm Prelabour rupture of membrane/ prelabour rupture of membranes
* Known allergy towards prostaglandins
* Intrauterine fetal death
* Known fetal anomaly
* Estimated fetal weight \>3.8kg by scan
* Grandmultiparity (more than 5)
* BMI \>40kg/m2
* Diabetes and hypertension on treatment
* Other medical illness on treatment
A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women

Based on the high incidence of cervical cancer and high grade dysplasia and increased progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the effect of cryotherapy among HIV-positive women diagnosed with CIN 1 versus regular 12 month cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have had a colposcopic biopsy for persistent LSIL as per standard of care.

Women with HIV have a higher risk of cervical cancer. Screening and treatment formaly of the disease is limited die to poor access of screening programs and multiple visits. Women with HIV also have high progressions rates of disease amd my need to be treated earliers. Cryotherapy is a low option and very easy to implement especially in low resource provinces.

* It is cheaper and easier to administer than Large Loop electrosurgical excision procedure (LLETZ)
* No histology or transportation costs of specimens
* Less invasive than LLETZ
* It is nurse driven and easily learned
* It decreases loss to follow-up of patients due to reduced waiting time, transportation costs, time off work and HIV stigma

Eligibility Criteria:
Inclusion Criteria:

* HIV -infected women whose biopsy proves CIN1 and who consent to study participants and procedures
* CIN1 with no visible lesion
* The entire ectocervical lesion should cover less than 75% of the cervix and not more than 2 - 3mm into the endocervical canal

Exclusion Criteria:

* Pregnant women
* Known and previous treatment for HSIL by any method (Cryotherapy, LEEP or cone biopsy)
* Women who are menstruating or who have active pelvic inflammatory disease will be deferred from the study until the infection is cleared or the menstrual cycle has ended; the patient may then participate in the study.
* Unsatisfactory colposcopic examination defined as inability to see the extent of the lesion in the endocervical canal and lesions deemed ineligible for cryotherapy by an OB/GYN specialist.
* Previous hysterectomy with removal of the cervix