cyrilzakka/clinical-trials huggingface dataset:
The Effect of Self-Management Support Provided to Hypertension Patients Affected by the Earthquake Via Tele-Nursing on Patients' Treatment Compliance and Self-Care Management

This important research includes a randomized controlled trial evaluating the potential of self-management support provided via telenursing to earthquake-affected hypertension patients to improve patients' treatment adherence and overall self-care management. This study will be carried out at Fırat University Hospital and will cover a wide range of effects on health outcomes in individuals receiving hypertension treatment. The sample selected from hypertension patients, which constitute the population of the research, was based on predetermined power analysis criteria. It has been determined that at least 51 hypertension patients should be included in each of the intervention and control groups, and accordingly, a total of 150 hypertension patients will be included in the study.

. The results obtained within this framework may provide guidance in the development and implementation of Turkey's health policies, and may also shed light on strategies for the management of other similar health problems. On the other hand, strengthening the digital health infrastructure and effective management of chronic diseases, which are among the health-related targets of the Development Plan, further emphasize the importance of this research. The success of the self-management model supported by tele-nursing can serve as an example in the integration of digital health technologies into Turkey's healthcare system and be an important step towards achieving strategic goals in this field.


Eligibility Criteria:
Inclusion Criteria:

* Being followed for at least 6 months with the diagnosis of essential hypertension,

  * Patients diagnosed with hypertension who suffered financial or moral loss after the earthquake
  * Located in Elazığ at the time of the February 6 earthquake
  * Continuing to live in Elazığ after the earthquake
  * Using antihypertensive medication,
  * No change in antihypertensive drug treatment has been made in the last month,
  * Computer/tablet/smartphone etc. to watch videos. having technological devices,
  * Having internet access,
  * Being over 40 years old,
  * Education level must be at least primary education level

Exclusion Criteria:

* Being pregnant or breastfeeding
* Presence of another accompanying chronic disease (Diabetes mellitus, cancer, chronic renal failure, chronic obstructive pulmonary disease, heart failure, etc.),
* Having physical (speech, hearing impairment, etc.), neurological and psychological problems that prevent filling out research forms and participating in training.
Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy

OBJECTIVES: I. Characterize the effect of prednisone on muscle protein metabolism in patients with Duchenne muscular dystrophy.

II. Determine whether prednisone changes levels of insulin-like growth factor 1, growth hormone, and insulin.

III. Characterize the effect of prednisone on muscle morphometry and muscle localization of utrophin.

IV. Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen in normal individuals and in patients with facioscapulohumeral dystrophy.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to prednisone or placebo. Therapy is administered daily for 12 weeks; prednisone is then tapered.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

* Ambulatory males with Duchenne muscular dystrophy
* No medical/psychiatric contraindication to protocol therapy
* No requirement for regular use of prescription medication
Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy

To date, few studies have addressed the link between gut microbiota and breast cancer chemotherapy, and previous studies have only provided a link between the gut and breast cancer.

To date, few studies have addressed the link between gut microbiota and breast cancer chemotherapy, and previous studies have only provided a link between the gut and breast cancer.At present, studies on the interaction mechanism between intestinal flora and breast cancer mainly focus on two aspects: first, intestinal flora affects the occurrence and progress of breast cancer by affecting estrogen metabolism;Second, intestinal flora can influence the occurrence and treatment of breast cancer by affecting the regulation of the immune system.However, the specific types (or groups) of bacteria that promote the occurrence, development and mechanism of breast cancer still need to be further studied.In addition, since most of the current clinical studies on microorganisms and breast cancer are small sample studies, the accuracy of their conclusions remains to be studied.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years
* First use of chemotherapy after breast cancer

Exclusion Criteria:

* Pregnancy
* Lactation
* Cigarette smoking
* Alcohol addiction
* Hypertension
* Diabetes mellitus
* Lipid dysregulation
* BMI \> 27
* Recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
* History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
* History of malignancy or any gastrointestinal tract surgery
Assessing Physical Activity Levels of Patients Following HTO.

High tibial osteotomy (HTO is often indicated in physically active patients. The insertion of a bone graft during surgery has been shown to have good clinical and biomechanical outcomes, however objective data regarding post-surgery physical activity (PA) levels in patients who have undergone HTO with and without bone grafts does not exist in the literature.

Using accelerometers and questionnaires, this study will be the first to investigate this in an objective way.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing unilateral medial opening wedge high tibial osteotomy at Basingstoke \& North Hampshire Hospital, UK

Exclusion Criteria:

* Concurrent procedures during HTO surgery
* The use of an off-loader knee brace in the 3 weeks leading up to surgery
* Revision surgery
Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection

Study to evaluate the safety, tolerability and antiretroviral activity of a new therapeutic strategy, based on the administration of dasatinib, an ITK, in patients with recent (3-12 months) asymptomatic HIV-1 infection.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years.
* Documented asymptomatic HIV-1 infection of 3-12 months duration (all patients must have a positive Western blot, including the p31 band whose appearance indicates infection of more than 90 days duration).
* Not having received ART
* CD4 T-lymphocyte count\> 350 / μl
* Patient giving written informed consent

Exclusion Criteria:

* Active HBV (HBsAg+ or DNA+) and/or HCV (RNA+) infection in screening.
* ALT\> 2 UNL, glomerular filtration rate \<70 mL / 1.73 m2, leukocytes \<4000 / mm3, total lymphocyte count \<1000 / mm3, platelets \<100,000 / mm3 or Hg \<12g / dL.
* Pregnancy or active breastfeeding
* Ongoing or previous pleural effusion
* Chronic obstructive pulmonary disease, bronchial asthma or recent chest trauma.
* History of gastrointestinal or other bleeding.
* Any concomitant treatment with potentially dangerous drug interaction with dasatinib.
* Any clinical condition, at the opinion of the investigator, contraindicating participation (for example,
* Active neoplastic disease, active concomitant infection, etc.)
Clinical and Comparative Evaluation of the Treatment Results of Arthroscopic Reconstruction of Cartilage Defects in the Knee Joint With the Use of Autogenous Cartilage Graft With PRP GF (Platelet-rich Plasma With Growth Factors)

Clinical and comparative evaluation of the treatment results of arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage graft with PRP GF (platelet-rich plasma with growth factors)

The main goal of the research project is to evaluate the results of the treatment of arthroscopic reconstruction of cartilage defects in the knee joint with the use of an autogenous PRP GF cartilage graft. The specific objectives are: to compare the results of treatment of analogous areas of the cartilage defects of the knee joint obtained in the study groups using two methods: microfracture and autogenous PRP GF cartilage graft (Auto Cart-Arthrex method). The results on the operated limb will be compared in both groups both between the groups and with the results of clinical and biomechanical tests on non-operated limbs.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years;
* Surgery for ACL damage to the knee joint;
* Arthroscopic surgery;
* No prior knee surgical interventions;
* No additional pathologies in this anatomical area;
* Informed consent of the patient to participate in the study.

Exclusion Criteria:

* Age under 18 or over 65;
* Previous surgical interventions in the examined anatomical area;
* Additional pathologies in this area identified as part of preoperative diagnostics;
* Damage to the second knee joint;
* Failure to comply with the rigor of the same rehabilitation treatment protocol.
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus

The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310
* Did not have a uterus
* Met the inclusion and exclusion criteria for Protocol 15-50310
* Had completed Protocol 15-50310 without any clinically significant abnormal findings at the end-of-study visit for Protocol 15-50310
* Provided written informed consent to participate in the study and agreed to follow dosing instructions and complete all required study visits

Exclusion Criteria:

* Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310
* Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures
The Role of Short Chain Fatty Acids in Microbiota-gut-brain Axis

The role of short chain fatty acids (SCFA) in the microbiota-gut-brain axis is examined in a sample of healthy volunteers. SCFA are the major products of bacterial fermentation of dietary fiber in the colon, and are hypothesised to mediate the bidrectional communication between the gut and the residing microbiota on the one hand, and the central nervous system on the other hand. We perform a 1-week intervention with SCFA and measure their effects on a range of affective outcomes in healthy male volunteers.

The study is an interventional double-blind, placebo-controlled, parallel group design with 3 arms (placebo, high-dose of SCFA, and low-dose of SCFA). The high and low doses of SCFA are equivalent to 20 and 10 grams of fiber respectively. Healthy male participants follow a low-fiber diet for the study duration (11 days). On day 4, baseline measurements are taken in the lab, including biological samples and psychophysiological measurements. Participants then consume placebo or SCFA for one week and revisit the lab on day 11 for a second measurement of the outcomes of interest. Specifically, we investigate the effect of SCFA supplementation on affective processing, including stress sensitivity, fear-related processes (e.g. extinction learning), and attentional bias to emotional stimuli. Volunteers also respond to questionnaires in relation to mood, and provide biological samples (blood and faecal samples) for analysis of circulating short chain fatty acids and microbiota composition, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Male participants
* Age range 20-40 years
* BMI range 18.5-27
* Dutch as native-language

Exclusion Criteria:

* previous or current neurological, psychiatric, gastrointestinal or endocrine disorders, or other relevant medical history
* current or recent regular medication use
* previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
* one or more diagnoses based on the mini-international neuropsychiatric interview
* smoking
* night-shift work
* adherence to vegan or vegetarian diets
* use of pre- or probiotics within one month preceding the study
* use of antibiotics within 3 months preceding the study
* previous experience with one of the tasks used in the study
Optimal Tailored Treatment for H. Pylori Infection

The efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was introduced and made commercially available. The primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. Specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.

Patients are randomly assigned to the empirical therapy group and tailored therapy group.

The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy group receives treatment based on their DPO-PCR results.

Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7 or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth quadruple therapy for 7 or 14 days.

Eligibility Criteria:
Inclusion Criteria:

* consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of H pylori infection

Exclusion Criteria:

* subjects younger than 18 years old
* subjects with a history of H pylori eradication
* subjects who had previous gastric surgery
* subjects who were pregnant or lactating
* subjects with serious concurrent illness
* subjects who were administered antibiotics, bismuth, or PPIs in the 8 weeks preceding the study
* subjects with a history of allergy to any one of the compounds in this study
A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).

This four-year, pragmatic, prospective study will compare the effectiveness of licensed egg-based inactivated influenza vaccines to the effectiveness of two other types of licensed vaccines, the cell-culture based inactivated influenza vaccine and the recombinant influenza vaccine, in the prevention of laboratory-confirmed influenza infection in active duty members, military retirees, and other DoD beneficiaries. Military treatment facilities (MTFs) in the United States will participate in this protocol. Enrollment will be restricted to adults (≥18 years and older) who are preparing to receive seasonal influenza vaccination at participating DoD sites. Subjects will be randomized to receive one of the three licensed influenza vaccines types for evaluation of effectiveness. There is no exclusion for pregnancy, as none of these licensed products are contraindicated in pregnant women.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible for care in Department of Defense medical facilities (Defense Enrollment Eligibility Reporting System eligible)
2. ≥18 years of age.
3. At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination.
4. Able to speak English and able to provide informed consent
5. Able to receive and respond to texts and/or emails, or a military recruit

Exclusion Criteria:

1. Adults intending to receive or who have received the current seasons FluMist Vaccine (LAIV)
2. Adults who have already received a flu vaccine within the current season
3. Individual who cannot receive a flu vaccine or standard dosing due to another medical condition
4. Allergic to gentamicin, polymyxin and/or neomycin
5. Individuals who fail to meet the inclusion criteria
The Change of the Tetanus Antibody Titer After Single Injection of Td and Simultaneous Injection of TIG With Td

The investigators want to determine whether TIG influences the formation of tetanus antibody after simultaneous tetanus vaccination according to age and the time-interval of the last tetanus vaccination.

When an injured patient visits the ED, unnecessary injection of tetanus immunoglobulin (TIG) may cause side effects and also increase the medical expense.5 Further, the opportunity of assessing a rising tetanus antibody titer may be missed after simultaneous injection of tetanus-diphtheria vaccine (Td) and TIG. According to age, the elevation of the tetanus antibody titer after tetanus prophylaxis might be not equivalent because of different levels of basal immunity and the time-interval of the last tetanus vaccination. Therefore, we wanted to determine whether TIG influences the formation of tetanus antibody after simultaneous tetanus vaccination according to age and the time-interval of the last tetanus vaccination.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult volunteers

Exclusion Criteria:

* immunocompromised
* febrile
* allergy to the vaccine constituents
* previous tetanus immunization within 5 years
* medical and non-medical employees
The Effect of Royal Vaginal Gel Compared to IUI Technique on Fertility Rate of Women With Low-fertility Husbands

The present Pocock clinical trial study was conducted In the city of Mashhad in Iran between 2015 and 2016. The study inclusion criteria were men with low fertility of sperm motility\<25% and total motility \<50% (asthenozoospermia), no history of endocrine diseases, no diabetes men, no hormonal problems in their wives, and a healthy salpingography in their wives. The study subjects were voluntarily assigned to royal gel and IUI groups. In royal gel group, 5 grams of royal gel was used after menstruation and every other night before and after intercourse. IUI group received 75 units of FSH from the second day of the cycle. Then vaginal ultrasound was performed from the sixth day of menstrual cycle to determine the right size of follicle. 10000 units of HCG was administered when follicle diameter reached 16mm, and the study subject was prepared for IUI 32-36 hours later. Each subject alternately swapped groups following fertility failure.

After selection of subjects and obtaining their informed consents, the quality of royal gel was examined.

The quality of royal gel is determined by the amount of polyphenol it contains. Polyphenol in royal gel was assessed in the following stages: first, the sample was diluted with ethanol 50% to 1:10 ratio, and then, 100µl of this preparation was poured into a test tube, and 750µl of 1:10 diluted solution of FCR (Folin Ciocalteau Reagent) was added and left at room temperature for five minutes. Then, 750µl of sodium carbonate 6% solution was added to each tube, and after keeping these tubes in the dark for one hour, absorption was measured at 780nm wavelength. Negative control consisted of all reaction compounds, except the sample, for which, ethanol 50% was used instead. The sample concentration was determined using the gallic acid standard. By definition, the desirable quality of polyphenol in natural royal gel ranges from 0.15mg (minimum) to 0.75mg (maximum) in every 100 grams, and this was determined 0.5 mg for the sample used in the present study, indicating a good quality (15).

Eligibility Criteria:
Inclusion Criteria:

* Male-factor infertility (defined as total sperm motility\<40% and sperm motility\<20%)
* Normal hormonal profile in women
* Normal hysterosalpingography report
* Regular sexual relationships

Exclusion Criteria:

* Ovulation dysfunction
* History of sexually transmitted diseases in women and men
* Hormonal disorders in men and women
Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data

This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia.

Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self monitoring of glucose levels is an important component of achieving and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can become less aware of it. This reduced aware of hypoglycaemia has significant risks including seizures, coma and even death, and has an impact on people's ability to drive and function.

The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14 days and is non-adjunctive (does not require calibration to capillary blood glucose).

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age
* Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide \<200 pmol/L
* Severe hypoglycaemic event in the last 12 months requiring third party assistance OR a Gold Score ≥ 4
* Type 1 diabetes for greater than 3 years
* On an intensified multiple dose insulin injection regimen for \> 6 months (MDI)
* Previous type 1 diabetes structured education (either group or 1:1)

Exclusion Criteria:

* Use of CGM or Libre device within the last 6 months (except short periods of diagnostic blinded use under clinic supervision)
* Use of regular paracetamol
* Pregnant or planning pregnancy
* Breastfeeding
* Enrolled in other clinical trials, except at the discretion of the chief investigator
* Have active malignancy or under investigation for malignancy
* Severe visual impairment
* Reduced manual dexterity
* Unable to participate due to other factors, as assessed by the Chief Investigators
Hormonal Influences on Diuresis

The aim of this study was to observe the effect of hormonal treatment (oral or transdermal substitution therapy) on diuresis (salt and water diuresis) and lower urinary tract symptoms (LUTS) in postmenopausal women


Eligibility Criteria:
Inclusion Criteria:

* Patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc)

Exclusion Criteria:

-