cyrilzakka/clinical-trials huggingface dataset:
A Roll-over Observational Study for the Extended Follow-up of the Volunteers of the ISS T-003 Trial

A roll-over observational study (ISS T-003 EF-UP) is being conducted to extend the follow-up of the volunteers of the ISS T-003 trial in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat.

An open label, non-interventional study roll-over study (ISS T-003 EF-UP) is being conducted to follow-up the persistence of vaccine humoral responses as well as of the immunological and virological effects induced by the therapeutic immunization with Tat.To this aim volunteers of the ISS T-003 study are included in one year study, with visits at weeks 0 and 24 and 54.

To assess the anti-Tat humoral immune response by the determination and titration of IgM, IgG and IgA anti-Tat antibodies (primary endpoint) and to evaluate CD4+ T cell counts and HIV-1 plasma viraemia (as secondary endpoint).

In addition, depending on the availability of residual specimens (PBMC, serum and plasma), further laboratory tests (i.e. HIV DNA copies in blood) to investigate in-depth the immunological and virological profile of the volunteers is being performed.

Physical examination is being performed to monitor the clinical status of the volunteers and to record the appearance of clinical signs and symptoms of disease progression as well as AIDS-defining events, data or records related to ARV treatment compliance. Pregnancy onset for female participants will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* previous participation in the ISS T-003 trial without withdrawal of consent;
* availability to participate in the extended follow-up study;
* signed informed consent.

Exclusion Criteria:

* The absence of any of the above criteria will exclude the participants from the study
Practice Patterns Among Gynecologic Oncologists on Tumor Genetic Testing in Endometrial Cancer

In order to formulate strategies to improve adherence to best practice guidelines, as well as utilization of novel therapies, investigators must understand current practice patterns surrounding tumor genetic testing in endometrial cancer. The aim is to survey a representative sample of gynecologic oncologists who belong to the society of gynecologic oncology, via an email survey, to better understand current practices surrounding tumor genetic testing as well as determine if there have been any changes to practice since the publication of recent trials on the use of immune-checkpoint inhibitors in endometrial cancer.

Primary Objective: Proportion of physicians reporting the use of different tumor genetic testing strategies among newly diagnosed endometrial cancer patients.

Secondary Objectives:

* Explore the use of informed consent in tumor genetic testing in endometrial cancer
* Explore clinician confidence in utilizing tumor genetic testing to guide treatment decisions.
* Explore the impact of recent publications regarding immunotherapy on the use of tumor genetic testing in endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

* Member of the Society of Gynecologic Oncology
* Gynecologic Oncologist or Gynecologic Oncology Fellow-in-Training
" Patients Attitude Towards Physicians and Health Screening Issues Among First Generation Asian-Indian Immigrants to United States".

Aim - To better understand expectations and attitudes of first generation immigrants from India to USA.

Background - The is large difference in healthcare system as practiced in India and in USA. Most people who have lived in India for certain period of their life have basic understanding of health-care system in India. In general it is the physician who makes choices for patients there , also the concept of health screening is less prevalent. After immigrating to USA these immigrants are exposed to new healthcare system. We donot have any data showing their attitudes to some specific questions and physician preference in general. We also have significant concentration of these ethnic group in the central valley.

With this questionnaire study we hope to get better understanding of their beliefs and expectations. We have tried to keep the questions simple and straightforward.


Eligibility Criteria:
Inclusion Criteria:

* First generation immigrants from India to USA
* Currently living in USA
* Planning to live in USA and utilize local healthcare facilities

Exclusion Criteria:

* Age \< 18
* People born in USA
Optimizing IVF Treatment - the Impact of Time-lapse Culture and Preimplantation Factor (PIF) on Embryo Development.

The aims of this study are to evaluate:

1. the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on fertilisation rates and embryo quality in standard IVF.
2. the association between PIF status in embryo culture medium and embryo quality assessed by standard subjective parameters and morphokinetic development.


Eligibility Criteria:
Inclusion Criteria:

* Standard IVF treatment
* Body mass Index (BMI) between 18 and 30
* couples in which the male partner has normal sperm concentration and motility according to the World Health Organization (WHO, 2010)

Exclusion Criteria:

- Patients with less than four oocytes
Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes

The purpose of this protocol is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Adults with obesity (BMI \>30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e. unstable angina).
* Age: 18-65 years.
* Gender: Men or women.

Exclusion Criteria:

* Weight change greater than 3% in the previous 3 months (weight stable).
* History of bariatric surgery including lap band and bariatric endoscopy.
* Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.
* Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM
* A positive score on the AUDIT-C questionnaire as judged by an investigator.
* Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence
The Significance of a Timely Food Allergy Diagnosis and Optimal Surveillance of Nutritional Status in Children

The aim of this study is to gain more knowledge on the nutritional and immunological aspects of allergy to milk and eggs in children.

Food allergy in children is an emerging problem in many countries. Milk and eggs are important sources of nutrition in childhood. Restricting these products in children's diets can affect the quality of child's life and nutrition, which is paramount to good physical and mental child development during this vulnerable period of life. The aim of this study is to gain more knowledge on the nutritional and immunological aspects of immunoglobulin E (IgE) mediated allergy to milk and eggs in children. In this study we will analyze parent perceived child's quality of life, factual nutrition (assessed by 3-day food diaries), food allergy self efficacy measure for parents, parent perceived quality of life will be assessed using Food Allergy Quality of Life Questionnaire - Parent Form, anthropometric measures of children (height and weight), serum nutritional markers (vitamin D, calcium, magnesium, iron and phosphorous), sensitization tests (specific Immunoglobulin E (sIgE) to milk and egg and their components) as well as markers of allergic inflammation (interleukin 10, 13, 17, 25 and 33, eosinophil count and serum Immunoglobulin E). Food allergy will be confirmed by an oral food challenge (OFC), variables will be compared between different OFC outcomes (sensitized-allergic/sensitized-non-allergic).

Eligibility Criteria:
Inclusion Criteria:

* Subjects from 6 months to 12 years of age and their parents / guardians.
* Subjects with suspected or confirmed allergy to chicken's egg and/or cow's milk. Suspected food allergy is defined as sensitization to a food that has not been consumed recently (in the last 3 months) without symptoms or sensitization to a food that has never been consumed. A confirmed food allergy is defined as a food allergy that has previously been confirmed by a positive result of an oral food challenge.
* Legal guardians of the subject are capable to sign a written informed consent form.

Exclusion Criteria:

* Subjects to whom food allergies are unlikely (who have recently eaten a suspected food without symptoms or who have not eaten food recently but have never had symptoms and are not sensitized).
* Subjects to whom an oral food challenge is contraindicated.
* Subjects with comorbid chronic diseases affecting the child 's nutrition and growth.
* Legal guardians of the subject do not wish to participate in the study or are unable to sign a written consent form.
Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography

This randomized study investigates the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient's electroencephalograms during general anaesthesia to assess the level of consciousness during anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation

Exclusion Criteria:

* Missing informed consent
* ASA V
* Preexisting neurological deficit
* Known pregnancy
* Hypotension (RRsys\<90mmHg), bradycardia (HR\<50/min), hypoxia (SaO2\<90%)
Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

Study Type and Design Prospective, Observational Study Rivaroxaban in Elderly AF patients with or without renal impairment in Korea

This study will investigate effectiveness and safety in elderly patients, the result from well-designed and high-quality prospective clinical registry collected through real-world clinical practice is expected to resolve current medical unmet needs of rivaroxaban in Korean elderly patients.

Primary Study Objective(s) To investigate the effectiveness of rivaroxaban in elderly patients with NVAF, with or without renal impairment in Korea real-world clinical practice settings Secondary Study Objective(s) To see safety outcome including major bleeding, clinically non-major bleeding, all-cause mortality rivaroxaban in subgroup based on risk factor(eg. Renal impairment) physicians' treatment pattern in rivaroxaban

Study Population Elderly patients with age ≥ 65 years with treatment naïve or treatment-experienced patients who are diagnosed with NVAF Expected number of patient enrollment is about 1200 patients, Samsung Medical Center is aim to enroll about 200 patients

Eligibility Criteria:
Inclusion Criteria:

1. Patients with consent given
2. Elderly patients with age 65 ≥ years old
3. NVAF patients first time prescription to rivaroxaban or patients who started rivaroxaban treatment within 3 months

Exclusion Criteria:

1. Refusal to participate in this study or to give an informed consent
2. Patients with moderate to severe mitral stenosis
3. Patients with mechanical valve
4. Contraindication from rivaroxaban Korea SmPC
Sweetheart-Register: Risk Management of Diabetics with Acute Myocardial Infarction

The Sweetheart register (Risk management of Diabetics with acute myocardial infarction) documents both the prevalence of pathologic glucose metabolism in consecutive high-risk patients with STEMI and NSTEMI in daily hospital routine as well as the anti-diabetic acute and long-term therapy. Furthermore the register will provide data about the implementation of new guidelines for the interventional and adjuvant medical therapy of STEMI and NSTEMI.


Eligibility Criteria:
Inclusion Criteria:

* consecutive patients with acute (no older than 24 h) ST-Elevation Myocardial infarction
* consecutive patients with acute (no older than 24 h) Non-ST-Elevation Myocardial infarction

Exclusion Criteria:

* missing informed consent
Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF patients with volume overload despite having received diuretics other than vasopressin antagonists


Eligibility Criteria:
Inclusion Criteria:

* Patients who are currently on treatment with any of the following diuretics

  1. Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
  2. Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
  3. Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
* Patients with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
* Patients who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion Criteria:

* Patients with acute heart failure
* Patients who are on a ventricular assist device
* Patients who are unable to sense thirst or who have difficulty with fluid intake
Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries

The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises 24 patients; included in it 6-8 weeks after natural delivery. The planned participation of each patient in the study is up to 4 weeks and three visits will take place at that time.

After obtaining written consent, at the screening visit (V0) each patient will undergo a physical examination, blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected.

On the second visit (V1), after the final verification of inclusion/exclusion criteria, impedance spectroscopy using tested device will be performed in each patient, the electrical impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage will be evaluated. Full gynecological and proctological examination (including a gynecological speculum, two-handed examination, rectal examination and anoscopy) will be carried out.

On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected data will be used to select the optimal therapeutic method for each participant individually.


Eligibility Criteria:
Inclusion Criteria:

* after natural delivery and post-partum period (6-8 weeks after delivery)
* physiological pregnancy
* observed a perianal tear of grade 1-4 in the OASIS classification
* signed informed consent

Exclusion Criteria:

* presence of acute diseases during treatment
* presence of chronic diseases untreated or insufficiently treated (e.g. poorly controlled hypertension),
* presence of diseases, with symptoms of fecal incontinence,
* previous proctological operations,
* the presence of inflammatory bowel diseases in the stage of exacerbation,
* treatment in the last year due to severe, progressive, uncontrolled cardiac, pulmonary, nephrological, infectious or psychiatric disease, which course could affect the patient's risk due to participation in study,
* significant deviations from the norm in a physical examination during V0 visit or laboratory tests taken during the same visit,
* significant disease symptoms so far undiagnosed and reported during the V0 visit
* presence or suspected malignant disease or previous oncological treatment during the last 5 years,
* presence of a cardiac stimulator or cardioverter-defibrillator,
* severe surgery or severe trauma in the last year.
Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia

Objective to investigate the protective effect of preoperative electroacupuncture on lung function in patients with mechanical ventilation for more than 2 hours under general anesthesia

Randomized parallel control study. From September 1, 2021 to December 31, 2022, patients with mechanical ventilation time more than 2 hours will be randomly divided into electroacupuncture pretreatment group and blank control group. The blood gas index, ventilator parameters and serum inflammatory factor concentration of patients will be evaluated to evaluate whether electroacupuncture has protective effect on lung function of patients with mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia in our hospital;
* Ages 18-60;
* American Society of Anesthesiologists (ASA) grade ⅱ \~ III , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
* Expected duration of operation \>2h;
* Surgical grade 2-4;
* No serious lung infection and lung disease;
* Body mass index (BMI) 18\~30 kg/m2; There are no contraindications for electroacupuncture stimulation.

Exclusion Criteria:

* Patients with severe circulatory or other system dysfunction;
* Patients with pulmonary and one-lung ventilation;
* Unwilling to cooperate with the patient;
* Patients with low compliance.
DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health

A lifestyle intervention study in infertile males of couples seeking fertility treatment with a DNA fragmentation index (DFI) above 15 percentage. A reduction in DNA fragmentation index of 10 percentage points is expected after 3-4 months of intervention.


Eligibility Criteria:
Inclusion Criteria:

* DNA fragmentation index above 15 %

Exclusion Criteria:

* TESA/PESA
Sex Impact on Long-term Outcomes of LDKT

The impact of donor and recipient gender combination on kidney transplant outcomes has been reported in several studies. The results vary greatly due to different factors, such as minor histocompatibility antigens, nephron overload, sex hormones, etc. Despite advancements in clinical practice, no large-scale studies exploring this question in living donor kidney transplantation have been conducted in the subsequent two decades. Our study aims to address this research gap and provide updated information on outcomes in relation to the gender combination following living donor kidney transplantation.

The impact of donor and recipient gender combination on kidney transplant outcomes has been reported in several studies, but with inconclusive results. From an immunologic perspective, the transplantation of male donor kidneys into female recipients was associated with an increased risk of graft failure and mortality due to H-Y minor histocompatibility antigens. Another theory, based on nephron overload and hyperfiltration, suggests that male recipients of female donor kidneys tend to experience worse outcomes due to the smaller size of female kidneys. Additionally, the influence of sex hormones has been explored. Aufhauser et al. found that estrogen acts as a protective factor against ischemia-reperfusion injury (IRI), resulting in a significantly lower incidence of delayed graft function (DGF) in female recipients compared to male recipients. These findings seem conflicting, and most of studies have primarily focused on deceased donor kidney transplantation.

In addition, Kayler et al. analyzed a transplant database encompassing 30,258 living donor kidney transplantations between 1990 and 1999. Their study revealed a significant advantage in graft survival for male recipients of male donor kidneys compared to the other combinations. Another study involving 5,716 HLA-identical sibling kidney transplantations between 1985 and 2000 demonstrated that female recipients tend to have better graft survival rates regardless of the donor's gender. Despite advancements in clinical practice, no such large-scale studies exploring this question have been conducted in the subsequent two decades. Our study aims to address this research gap and provide updated information on outcomes in relation to the gender combination following living donor kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing living donor kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.

Exclusion Criteria:

* Recipients who were under 18 years at transplant or had no follow-up.
The Effect of Using Music and Natural Landscape Paintings on Pain Level, Anxiety and Analgesic Use of Women During HSG

The study was planned as a randomized controlled study in order to evaluate the use of music and natural scenery paintings in women who underwent HSG procedure, their pain level, anxiety and post-procedure analgesic use.

The universe of the research; Women who apply to Dicle University Hospital's Obstetrics and Gynecology Polyclinic will be recommended to have an HSG.

Sample of the research:

Women who applied to the Dicle University Hospital Obstetrics and Gynecology Outpatient Clinic and recommended to have an HSG will participate in the study.

In the calculation of the sample size of the research, in the calculation made in line with the data taken from the reference studies; The sample size was used at the 95% confidence interval, the effect size was 0.80, and the alpha was 0.05, and it was seen that at least 29 individuals should be included in each group.

Application of Research The study was planned to be conducted on women who were recommended to have an HSG, who applied to the Dicle University Hospital Obstetrics and Gynecology Clinic between January 2022 and July 2023 in a randomized controlled manner. The Socio-Demographic Data Questionnaire, Visual Pain Scale, State-Trait Anxiety Inventory, and the Socio-Demographic Data Questionnaire, prepared by the researcher for the women who were selected in accordance with the sample selection criteria and accepted to be a participant, in line with the recommendations of the academicians specialized in the field of Gynecology and Gynecology Nursing. Analgesia Follow-up Form will be applied.

After the control group study is completed, the case group study will begin. The reason why the control and case groups were not studied at the same time was because it was thought that women saw each other and would be affected by each other.

In the control group, only the pre-test before the procedure, the post-test after the procedure and the use of analgesics within 24 hours after the HSG will be questioned with data collection tools and no attempt will be made.

Case groups will be pre-tested before the procedure, they will be listened to music or shown pictures of natural landscapes during the procedure, and after the procedure is completed, the post-test will be applied and 24 hours after the procedure, they will be contacted and questioned whether they use analgesics.

Eligibility Criteria:
Inclusion Criteria:

* In the research be over 18 years old
* At least primary school graduate
* Not have a diagnosed psychiatric illness
* Not having mental deficiency and communication problems
* No drug sensitivity or allergy
* Not having received infertility treatment before
* Being diagnosed with primary infertility

Exclusion Criteria:

* To be illiterate be under the age of 18
* Having a diagnosed psychiatric illness
* Mental disability and communication problems
* Having drug sensitivity and allergy
* Being diagnosed with secondary infertility