cyrilzakka/clinical-trials huggingface dataset:
Transport of Satiety Factors Into the CSF

The blood-brain barrier regulates the passage of peripheral built appetite-suppressing hormones from the blood to the brain and informs the brain about the nutritional- and energy status.

The aim of this study is to investigate in which extent the hormones are able to overcome the blood-brain barrier and how long it takes after food intake. Relating thereto indications to the effect of peripheral hormones in the central nervous system and the role of these hormones in the development of overweight are provided.

In this study 30 patients (10 per intervention group) will be recruited. The patients are hospitalized in the local neurosurgery and they have a CSF-drainage due to their neurological primary disease or due to neurosurgical interventions. The patients are examined in each case on the same day.

Simultaneous samplings of blood and CSF are taken from 10 patients after an oral glucose tolerance test. These interventions are carried out to investigate in which extent the appetite-suppressing hormones (e.g. Leptin, Insulin, GLP 1 and Glucagon) reach the liquor and so the central nervous system.

In order to understand the temporal sequence, simultaneous samplings of blood and CSF are taken from 10 other patients at certain points throughout the day.

In a further group of 10 patients will be investigated how the central effective insulin modulates the transport of the other appetite-suppressing hormones. Therefore samplings of blood and CSF are investigated before and after intranasal insulin administration.


Eligibility Criteria:
Inclusion Criteria:

* patients with cerebrospinal fluid drainage

Exclusion Criteria:

* Women during pregnancy and lactation
* Participation in other interventional clinical trials
* severe infection within the last 4 months
* intake of central effective substances which may interact with the transport processes to be investigated
* hypersensitivity to any of the substances used
* diabetes mellitus
* Patients with CSF results indicative of infectious diseases within the central nervous system
* subjects with hemoglobin Hb \<10 g / dl
* Patients with a neurosurgical disorder suspected of having a blood-brain barrier disorder
Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture

The aim of this study will be to evaluate the non-inferiority of implants produced by additive manufacture loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up

This randomized Split-mouth clinical study of non-inferiority will monitor for one year partially edentulous patients in the posterior region of the mandible or maxilla, rehabilitated with 2 implants (AM) in the same Arch to evaluate the success rate of the implant, one loaded at 30 days after installation and the other at 90 days. Changes in marginal bone level and osseointegration success will be evaluated, with visits and data collection in 0 days (baseline), 30 days, 90 days, 6 months and 1 year

Eligibility Criteria:
Inclusion Criteria:

* Patients treated and referred by the Dental Clinic of the School of Dentistry of the University of São Paulo;
* Individuals over 18 years and under 70 years of age;
* Good general health;
* signed Informed Consent Form;
* Need for rehabilitation with dental implants in areas of mandible or posterior maxilla (premolars and/or molars);
* bacterial plaque index ≤ 20% (Silness \& Loe, 1964);
* bleeding rate of ≤ 20% (Loe \& Silness, 1963);
* Sufficient alveolar bone volume for an implant of:

  * Length: 8 or 10mm
  * Diameter: 3.5mm, 4. 00mm or 4. 5mm
* Bone quality type I-III;
* No associated bone regeneration.

Exclusion Criteria:

* Pregnant and lactating women;
* Uncontrolled diabetes;
* History of chemotherapy or radiotherapy in the last 5 years;
* Radiotherapy in areas of the head and neck;
* Use of immunosuppressants, bisphosphonate or prolonged use of corticosteroids;
* Smokers;
* Alcohol or drug abuse;
* Untreated periodontitis;
* History of previous bone increase in the implant installation region;
* Presence of residual roots at the site receiving the implant;
* Bone density type IV
* Individuals with connective tissue disorders or metabolic diseases;
* Postmenopausal osteoporosis or other systemic diseases that may affect bone metabolism;
* Need for guided bone regeneration at the time of implant installation.
Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients

The purpose of this study is to determine the efficacy of antioxidant cocktails on the alleviation of oxidative stress and iron overload in beta-thalassemia/Hb E patients.

60 cases of beta-thalassemia/Hb E patients. All patients will be diagnosed with hemoglobin typing of beta-thalassemia/Hb E disease and not receive blood transfusion or any treatment at least 3 months prior study. The study will be randomized controlled trial that designed before and after treatment with antioxidant cocktail. The antioxidant cocktail consists of vitamin E 400 IU/day, curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day. All patients will receive antioxidant cocktail daily for 12 months. The patients will be regularly followed up and analyzed biochemical parameters every two months during treatment and after withdrawal for 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18-50 years
2. hemoglobin level between 6-9 g/dL during screen visit
3. WHO performance status grade 0-2
4. signed in informed consents prior to the study entry.

Exclusion Criteria:

1. receiving iron chelator and blood transfusion.
2. pregnancy or breastfeeding
3. receiving other drugs except folic acid at least 30 days before study.
XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI

The investigators will use EEG, structural MRI, and resting-state functional connectivity MRI to assess neuronal responses in 28 healthy subjects to different somatosensory stimulations.

To develop a better understanding of the cerebral response to a complex somatosensory intervention with XNKQ acupuncture and to build a foundation for future studies with stroke patients our study aims to evaluate changes of brain activity and brain structure in healthy subjects after XNKQ acupuncture in comparison to three control interventions. We will use EEG, structural MRI, and resting-state functional connectivity MRI to assess neuronal responses in 28 healthy subjects to a) strong manual needle-stimulation of the acupuncture points DU26, PC6 and SP6 (XNKQ acupuncture), b) insertion of needles on the acupuncture points DU26, PC6 and SP6 without stimulation (control 1), c) strong manual needle stimulation of three non-acupuncture points (control 2), and d) insertion of needles on three non-acupuncture points without stimulation (control 3). With this, our study aims to create results which inform future studies in patients and might be helpful for the rehabilitation of deficits after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (18 to 40 years of age) health status confirmed by a comprehensive neurological examination
* Right-handed (evaluated by "the Edinburgh inventory")
* Informed consent
* No acupuncture treatment in the last 12 months
* No medical knowledge about acupuncture

Exclusion Criteria:

* History of neurological and/or psychiatric diseases
* History of brain injury
* Cognitive handicap and severe speech disorder
* alcohol or drug abuse
* History of neurosurgical intervention
* Chronic disease (e.g., asthma, diabetes mellitus etc.) with regular use of medications
* Usage of acute medication
* Pregnancy (tested by urine pregnancy test before the measurement) or planned pregnancy
* Any contraindication for acupuncture (e.g., anti-coagulation therapy)
* Any exclusion criteria for MRI scanning (metal implants (e.g. pacemaker), claustrophobia, etc.)
* Participation in another interventional trial.
The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)

This clinical trial aims to explore the effectiveness and safety of gait improvemen of Neuclare, a science medical device, for patients with Idiopathic Normal Pressure Hydrocephalus (iNPH) Through methods such as Timed Up \& Go Test (TUG), 10m gait , iNPH grading scale), etc, gait improvement before and after using Neuclare will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 60 to 90, regardless of gender
* Individuals exhibiting gait disturbances along with at least one of the following symptoms: cognitive impairment or urinary incontinence
* Evans' index \> 0.3)
* When the symptoms in 2) and 3) cannot be fully explained by other neurological or non-neurological diseases
* Diagnosis of INPH based on the Investigator's clinical judgement based on criteria as described in the INPH Guidelines

Exclusion Criteria:

* Patient with pathological lesions in the brain identified by MRI
* A person who is confirmed to have organic brain lesions (e.g., cerebral edema, cerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.) on a brain MRI.
* Patients with metabolic disorders such as thyroid dysfunction, hyperglycemia, hypoglycemia, liver or kidney dysfunction, and long-term use of drugs that will cause cognitive decline (e.g., anticholinergic drugs)
* History of psychiatric disorder other than the inclusion criteria.
* A person with a severe history of cancer/tuberculosis
* A person who has contact dermatitis or sensitive skin abnormalities
* Patients with a high fever of 40 degrees Celsius or higher based on eardrum body temperature
* A person whose bleeding is identified due to a common procedure or surgery that may affect vital signs
* A person who is unable to perform MRI tests
* A person with an allergic reaction to MRI contrast agents such as Definity or Gadovist.
* Other cases where the investigator judged that it is difficult to participate in the study
* Patient with behavioral and psychological symptoms of dementia (BPSD) that make cooperation in the clinical trial difficult
* Patients with severe cognitive impairment, defined as an MMSE score of 17 or below
* Patients who have undergone shunt surgery in the past year
* Patients with a history of uncontrolled thyroid, liver, or kidney dysfunction
* Patients taking medications that affect gait, cognition, or urinary tract function and who have had a change in medication regimen within the past 3 months.
* Patients who have undergone a cerebrospinal fluid drainage test within the past 1 month.
Isometric Handgrip Exercise for Blood Pressure Management

The aim of this project is to conduct a randomised controlled trial to assess the effect of performing isometric exercise using a handgrip dynamometer on blood pressure.

Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic exercise for lowering blood pressure. A randomised controlled study will be conducted with participants who are either pre-hypertensive, blood pressure between 120/80 and 140/90, or on medication to control their blood pressure. Previous studies have utilised a sedentary control so we intend to use a sham group to determine if it can be used as a working control for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Those within the required age limits, both normotensive, pre-hypertensive, and those medicated for blood pressure management.

Exclusion Criteria:

* Younger than 30 years and older than 70 years; those deemed not to have the capacity to voluntarily participate, unable to participate under their doctor's recommendation, or with arthritis or carpal tunnel syndrome who may aggravate their condition with handgrip exercise.
Anesthesia Awareness in Pediatric Gastrointestinal Endoscopy Nurses

Background and Aim: Pediatric gastrointestinal (GI) endoscopy is an increasingly common procedure performed to investigate and diagnose problems in the GI tract in children. Procedures in pediatric endoscopy units are routinely performed under sedation and general anesthesia, unlike adult endoscopy. Nurses working in pediatric gastroenoscopy units where sedoanalgesia is applied have important duties and responsibilities in terms of quality standards in preoperative, intraoperative and postoperative periods. Considering the increasing need for high-quality pediatric endoscopy applications, the attitudes and behaviors of nurses about sedation in pediatric patients are important as a member of the team. There is almost no literature on the experience and awareness of pediatric endoscopy nurses in clinical practice, and this encourages our team to conduct a survey across our country and to develop knowledge and clinical practices. With this questionnaire survey, it was aimed to evaluate the experience and attitudes of the endoscopy nurses working in the pediatric endoscopy unit in our country on sedation/general anesthesia management for pediatric patients

Design: This research is a questionnaire survey. There will be no scaling in survey questions. The volunteers who will participate in the survey are nurses working in the pediatric endoscopy unit throughout Turkey, and the sample size was not calculated because it was desired to study in the whole universe and sampling was not used. Approximately 80 endoscopy nurses work in the pediatric endoscopy unit in Turkey. The universe consists of about 80 volunteers. Power analysis of the research will be done after the study is completed.

Methods: For this study, pediatric endoscopy nurses working in different clinics across our country will be invited. Questionnaires will be delivered to nurses through hospital visits or electronic media. The prepared questionnaire consists of a total of 33 questions evaluating nursing services on demographic data and sedation practices in pediatric endoscopy nurses' units. Of the 33 questions, 7 of them question the information about the socio-demographic data and professional experience of the pediatric endoscopy nurses, 16 of which will be answered as "yes" or "no" about the nursing services and approaches related to anesthesia management, the remaining 10 will consist of questions to be answered as "I agree" "I am undecided" "I do not agree".

Eligibility Criteria:
Inclusion Criteria:

* All pediatric endoscopy nurses working in the pediatric endoscopy unit in our country

Exclusion Criteria:

* Pediatric endoscopy nurses who will not want to participate in this questionnaire survey
A Multi-center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-up of LSIL Cases

The aims of this study are:

1. Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors.
2. Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases.

Carcinoma of the uterine cervix is by far the most prevalent cancer of women in Taiwan and worldwide. In 1994, it ranked the top of female cancer incidence with 3000 new cases annually and claimed nearly 1000 lives. The major cause of this malignant disease is now pointed to the infection of oncogenic types of human papillomavirus (HPV). HPV infection is sexually transmitted, affects the immature metaplastic cells of uterine cervix and, in an unknown proportion, results in squamous intraepithelial lesion (SIL) of differing severity. The natural history of HPV infection is by far elusive. It is not clear how the virus get into the cell, how the immune system respond to it, and how the epithelial cell get transformed. An average estimation holds that about 60% of low grade SIL will regress, 30% will persist, 10% will progress to high grade lesions and less than 1% become invasive lesions.

The aims of this study are:

1. Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors.
2. Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases.

Through a consensus of management of patients with abnormal Pap smear in TGOG, a standard protocol of specimen collection, clinical follow-up has been established. Patients with a Pap smear of ASCUS, AGCUS or SIL will be arranged with a repeat Pap smear and a colposcopy with or without biopsy. A cervical swab will be taken and sent to the core laboratory for HPV DNA detection and genotyping. Pap smear and biopsies were then panel-reviewed by Pathologists. Cytology-or pathology-proved LSIL cases will be followed every three months with Pap smear, colposcopy and HPV test until disease progression or two consecutive negative results of all the three data. One thousand cases fulfilling "aim 1" will be analyzed during the first year, and the nature course of about 300 LSIL cases will be followed at the end of the third year.

Eligibility Criteria:
Inclusion Criteria:

* Women visiting the gynecologic clinic of the participating medical centers and have a recent (within three months) Pap smear result of ASCUS, AGCUS, LSIL and HSIL of during the study period will be invited to this study.
* An informed consent signed.

Exclusion Criteria:

- Women who are not pregnant, had had no previous CIN
Detection of Pattern of Some Unusual Signs and Symptoms of Multiple Sclerosis

Each Multiple Sclerosis patient will be submitted to Cognitive Abilities Screening Instrument (CASI), Expanded Disability Status Scale, Epowrth Sleeping Scale(ESS),Fatigue Severity Scale(FSS), Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Headache Disability Index, specific questionnaire based on International Headache Society (IHS) recommendations


Eligibility Criteria:
Inclusion Criteria:

1. Male or female.
2. Age:30-50 years
3. Accepting all study requirement

Exclusion Criteria:

1. comorbid patient e.g (diabetic, hypertensive.......etc )
2. opposition of the patient or their family
Vitamin D, Cardiovascular Disease, and African Americans

African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D levels; however, there is a lack of interventional trials exploring this connection. The objective of this proposal is to address the hypothesis that treatment of vitamin D deficiency in African Americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.

This study will be a double blinded, randomized controlled trial of vitamin D3 supplementation, 4,000 international units per day versus 600 international units per day, for one year to determine the effects on markers of subclinical cardiovascular disease in African Americans with type 2 diabetes and vitamin D deficiency. Outcome assessment will focus on changes in carotid intima-medial thickness (CIMT - ultrasound of the thickness of blood vessels in the neck), as well as markers of systemic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* African Americans of both genders
* Age 50-70 years
* Type 2 diabetes (A1C \< 9.0%), on stable therapy with oral medications, insulin, or a combination
* 25(OH)D level \< 20 ng/ml
* BP \< 140/90 mmHg; LDL \< 140 mg/dl

Exclusion Criteria:

* Pregnancy
* Cardiovascular disease
* Stage 3 or worse chronic kidney disease
* High urine or serum calcium or history of recurrent kidney stones
* Unstable medical conditions or major systemic diseases such as malignancy
A Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd

Pancreaticoduodenecotmy(PD) is considered as the standard procedure for peri-amplullary or pancreatic head tumors. Laparoscopic pancreaticoduodenctomy(LPD) has been reported with minimal invasive advantages, such as small incision, less blood loss, less pain, et al. Further, some trials showed LPD got less morbidity and shorter length of stay. Pancreatic fistula is the major complication for pancreaticodupdenectomy and associated with numerous serious complications, suffering reoperation or sometimes death. The reported rate was 10% to 55%. A lot of modified procedure have been proposed to reduce pancreatic fistula. Omental flaps around anastomosis have been used to prevent post pancreaticoduodenectomy fistula or hemorrhage. However, the outcomes are controversy. A modified omental patch work has been used during LPD and the initial outcomes are good. This is a pilot study to evaluate the function of the modified omental patch work on decreasing the pancreatic fistula.


Eligibility Criteria:
Inclusion Criteria:

1. . Disease of periampullary or pancreatic head tumor
2. . Age: 18 years or older
3. Distant metastases are not diagnosed preoperatively.
4. . Patients who can provide written informed consent

Exclusion Criteria:

1. . Patients with severe organ disease such as cardiac disease,respiratory illness
2. . Patients with extended LPD or vessels reconstruction
3. Patients with conversion to laparotomy
4. . Patients with pregnancy
The Effect of Exercise and/or Diet on Health Related Parameters

The study evaluates the effect of exercise and/or diet during on body weight, body composition and health related blood parameters. Participants are overweight sedentary females, allocated to four different groups: Normal diet, Low-carb-high-fat diet, Normal diet + exercise, Low-carb-high-fat diet + exercise.

Diet and exercise can both be efficient tools to reduce bodyweight, get healthier body composition and improve many different health related blood parameters such as cholesterol and glucose tolerance.

Exercise has superior effect on skeletal muscle in the context of glucose tolerance, but adherence to exercise program can be a huge challenge for overweight individuals. While exercise has profound effect on metabolic health, diet has been superior when it comes to weight reduction. Previous studies have shown that 5-7% weight loss can improve glucose tolerance, measured as reduced fasting glucose and reduced 2-hour post prandial glucose.

We wish to see if the combination exercise and diet is superior to diet only when it comes to over all health.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Sedentary
* Premenopausal
* Caucasian
* BMI 26.9 - 36.1
* Age 33-4
* Living close to, or in Oslo.

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Smoking or tobacco use
* Previous medical history of cardio-vascular disease (CVD)
* Previous medical history of diabetes
* Previous medical history of endocrine disorder
* Previous medical history of kidney disease
* Use of lipid lowering medication
* Use of diabetes medication