cyrilzakka/clinical-trials huggingface dataset:
Improving Gynecological Examination Skills with the Use of a Model

Vaginal, abdominal, and breast examinations are among the essential gynecological examination skills for midwifery students and are crucial steps that need to be learned. However, due to the privacy of genital areas, there are some debates regarding the teaching of these skills. Low-fidelity mannequins and models are particularly effective and cost-efficient in acquiring basic psychomotor skills. Thus, midwifery students can gain clinical experience, make mistakes in a safe environment, and enhance their skills. The sample of this study consists of 64 midwifery students (experimental=32, control=32) using a pre-test, post-test design with an observational randomized controlled trial. Data collection instruments include a Personal Information Form (PIF), Learner's Guide (LG), Self-Confidence Scale (SCS), and Self-Confidence in Learning Scale (SSSCLS. In the experimental group, after providing theoretical knowledge, students will receive practical training on a gynecological examination model, including bimanual examination, vaginal examination with a speculum, pap smear for cervical screening, and pelvic palpation. Each student will then perform the examination individually, with approximately 15 minutes allocated per student. Two weeks later, the same students will be asked to perform all examination steps again. During the examinations, the researcher will mark complete and incomplete procedures in the learner's guide, and any deficiencies will be explained to the students for completion. The CS and SSSLS will be administered for the post-test. In the control group, after theoretical knowledge is provided, students will be shown visual and video demonstrations of the steps of a gynecological examination. The PIF and SCS will be administered for the pre-test, and two weeks later, students will be asked to perform the examination steps in a laboratory setting, followed by the post-test.

Gynecological examination is an important step for women's health. Early diagnosis, treatment, intervention, and follow-up are the foundation of a healthy life. Midwives play an important role in maintaining women's health, especially in conducting detailed gynecological and obstetric evaluations. They should receive quality theoretical education and improve their practices. Practical training is important in learning, especially in the health field where models and simulation applications play a significant role in clinical practices. Therefore, clinical examination skills are sometimes taught to students using different materials, making it easier for students to learn medical knowledge and reducing the time spent on education. The aim of this planned study is to improve midwifery students' gynecological examination skills with model support.

Eligibility Criteria:
Inclusion Criteria:

* Being a 3rd or 4th year midwifery student at Karabük University Faculty of Health Sciences

  * Being between the ages of 18-25
  * Voluntarily agreeing to participate in the study
  * Being a citizen of the Republic of Turkey

Exclusion Criteria:

* Leave whenever you want without working.
The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy

This is a prospective, double blind randomized controlled trial. In this study we will investigate the influence of hyaluronic acid injection to knee after knee arthroscopy, when known or discovered cartilage damage greater than International Cartilage Research Society score (ICRS) grade 2 is found. The indication for arthroscopy is not necessarily the cartilage damage. A set of 3 consecutive injections will be administered and follow up of physical examination and questionaries will be done.

Our null hypothesis is that the administration of hyaluronic acid will show decrease pain and quicker rehabilitation and return to normal activity in patients with grade 2 and higher cartilage damage that had gone through knee arthroscopy.

The use of hyaluronic acid is well known as one of the treatment modalities for knee osteoarthritis (OA) .Arthroscopy is a controversial treatment option for knee OA but in some cases, during knee arthroscopy done for other indication, cartilage damage is noted. This cartilage damage may slower the healing and rehabilitation process after knee arthroscopy. Therefore we will evaluate the influence of hyaluronic acid injection on the healing and rehabilitation process following knee arthroscopy.

All patients will be recruited prior to the arthroscopy. All patients will sign a concent form.Patients will be randomly divided to 2 groups which are the 2 arms of this study - treatment group and control group. All patient will be examined by a senior orthopedic surgeon and will fill the pre operative questionnaires. MRI scan of the operated knee prior for the surgery will be collected and evaluated.Knee arthroscopy will be performed by 2 senior orthopedic surgeons. Data and arthroscopic findings will be collected and documented during surgery. 2 weeks after surgery patients will be evaluated in the hospitals' outpatients clinic. The treatment group will be given a series of 3 injections of Sodium Hyaluronate 1%(ARTHREASE, TM) - one injection per week. The control group will be given a series of 3 injections of placebo (BPS - Buffer Phosphate Solution - the buffer solution of the hyaluronic acid regular injections). The syringes will be blinded to the patients and the physician.

questionnaires will be given at 2 weeks, 6 weeks, 3months and 6 months post operatively

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* signing a concent form
* Assigned for knee arthroscopy.
* Known chondral lesion of at least ICRS grade 2 in one or mor of the knee compartments per MRI prior to knee arthroscopy.
* Cartilage lesion of at least ICRS grade 2 in one or mor of the knee compartments that was found during the knee arthroscopy.

Exclusion Criteria:

* Rheumatic disease
* Synovial disease such as (but not limited to) Pigmented ViloNodular synovitis (PVNS)
* Infection of the operated knee - new or previous
* Pregnant women.
Yoga for Adolescents

Purpose: Specific effects of high-density Hatha Yoga(HY) training in adolescents have not yet been clarified. Aim of our study is to investigate the effects of high-density HY education on physical fitness, pulmonary function and quality of life in healthy adolescents. Methods: 28 female adolescents will be randomly divided into two groups as yoga training and control groups. Training group will receive high-density HY training for 8 weeks, two days a week under the supervision of a physiotherapist and one day a week home program. Control group will not receive any exercise. Flexibility of individuals will be determined by sit-reach, back scratching, lateral flexion tests; muscular endurance by sit-ups, sit down-stand up on chair tests, balance by time up-go test; cardiorespiratory capacity by incremental shuttle walking test(ISWT) and respiratory functions by spirometry, quality of life will be determined by with the Quality of Life Scale for Children.


Eligibility Criteria:
Inclusion Criteria:

- Female adolescents between the ages of 14 and 18

Exclusion Criteria:

- Individuals with recent muscular skeletal, neuromuscular and chronic systemic diseases that could prevent exercise
Expanded Access Protocol to Provide Patisiran to Patients With Transthyretin-mediated Amyloidosis With Cardiomyopathy

The objective of the study is to assess the long-term safety of patisiran in patients with ATTR amyloidosis with cardiomyopathy as assessed by a review of adverse events (AEs).

Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy; AND

  * Had an inadequate response to or could not tolerate standard of care, in the opinion of the investigator.
* Is not eligible for on-label use of commercial patisiran in the opinion of the investigator.

Exclusion Criteria:

* New York Heart Association (NYHA) Class IV
* NYHA Class III AND ATTR amyloidosis disease Stage 3 (defined as both N-terminal prohormone B-type natriuretic peptide (NT-proBNP) \>3000 ng/L and estimated glomerular filtration rate \[eGFR\] \<45 ml/min/1.73 m\^2). \[Gillmore 2018\]
* Current or future participation in another investigational device or drug study, scheduled to occur during this study, or has received an investigational agent or device within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to dosing (Day 1). Patients who have previously participated in a gene therapy trial for hATTR amyloidosis.
* Patients currently enrolled in, eligible for inclusion in, or who have dropped out of an ongoing interventional (therapeutic) clinical trial related to ATTR amyloidosis.
Gut Microbiota in Metabolic Surgery

Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.


Eligibility Criteria:
Inclusion Criteria:

* Be approved and scheduled for metabolic surgery at the Vanderbilt University Medical Center
* Have a history of type 2 diabetes, hypertension, or dyslipidemia
* Be able and willing to provide personal information and biological samples needed for the study

Exclusion Criteria:

* Prior gastric operations
* A history of coronary artery disease, stroke, heart failure, HIV infection, or untreated viral hepatitis
* Chemotherapy or radiotherapy for cancer within 2 years
* Current inflammatory bowel disease or celiac disease
* Vomiting, constipation, or diarrhea within 7 days or use of antibiotics within 2 months
Comparison of Body Dissatisfaction Among Islamic Veil Practicing (IVP), Non-Complete IVP, and Inconsiderate to IVP Women

The aim of this research is to examine the social, psychological and Islamic veil practicing (IVP), non-complete IVP and Inconsiderate to IVP correlates of body mass index (BMI) status in a women population. It is hypothesized that women who are IVP would differ on depression, and social variables compared with their non-practicing peers.

In this cross-sectional study, a population-based sample of 1774 female responded anonymously to an aerobic health club administered questionnaire. Body mass index was calculated from height and weight and categorized into four classes of underweight, normal, overweight, and obese. The questionnaire also included questions about social experiences, body dissatisfaction as Body Shape Questionnaire (BSQ), future goals and Islamic Veil Practicing (IVP). Persian version of Beck Depression Inventory (BDI-II Persian) and Rosenberg Self Esteem Scale was also distributed among six groups of women having IVP/regular exercise (RE), IVP/non-RE, Non-complete IVP/RE, Non-complete IVP/non-RE, Inconsiderate to IVP/RE, and Inconsiderate to IVP/non-RE. Correlations of BMI with social, psychological, future goals and IVP were explored

Eligibility Criteria:
Inclusion Criteria:

* Open for all women practicing Islamic veil, Non-complete IV, or Inconsiderate to IV

Exclusion Criteria:

* Overt signs of Anorexia Nervosa, Bulimia Nervosa
Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study

The study will test the efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis. The DEB (paclitaxel eluting balloon) will be used in the intervention group, while the plain old balloon(POB) will be used in the control group. The primary outcome is the effect of blood pressure control.


Eligibility Criteria:
Inclusion Criteria:

* age between 18y and 45y.
* with ≥ 60% stenosis in at least one renal artery.
* with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg).
* patients with no severe renal insufficiency (eGFR\>30 ml/min, length of the kidney ≥ 7cm).
* Good compliance.
* with informed consent.

Exclusion Criteria:

* With apparent atherosclerotic risk factors.
* With renal intervention or surgery history.
* With congenital anatomical anomaly.
* With severe renal insufficiency (length of the target kidney \< 7cm, total
* eGFR\<30ml/min, divided eGFR of the target kidney\<8 ml/min)
* With contraindication for antiplatelet therapy.
* With severe cardiopulmonary insufficiency.
* Allergic to contrast medium
* Being pregnant or preparing for pregnancy
* With active cancer.
* Life expectancy \< 12 month
* Without informed consent
The Lateral Tibial Tunnel in ACL Surgery

The Lateral Tibial Tunnel technique is a new concept in Anterior Cruciate Ligament (ACL) surgery. In this technique a tibial tunnel is drilled from the antero-lateral side of the tibia towards the ACL footprint. This technique allows the surgeon to deal with bone stock problems in the antero-medial part of the tibia as often encountered in ACL revision surgery. In ACL revision surgery it is often impossible to perform a one-stage revision surgery procedure due to bone stock deficiency in the antero-medial side of the tibia. It is hypothesized that the Lateral tibial tunnel technique allows the surgeon to perform a one-stage procedure instead of a two stage procedure. Furthermore the lateral tibial tunnel technique allows better graft fixation in two-stage ACL revision surgery. Several biomechanical studies proved biomechanical superiority of the new technique compared to the classical technique.


Eligibility Criteria:
Inclusion Criteria:

* patients requiring ACL revision surgery
* patients requiring ACL surgery who have bone stock problems at the medial side of the proximal tibia
Gonadal Toxicity in Women With Hodgkin Lymphoma

The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma (HL) since 1988. This archive represents a homogeneous series of consecutive patients with HL. The very long follow up and the availability of clinical and treatment data make it feasible to perform a study on the gonadal toxicity related to treatment for HL.


Eligibility Criteria:
Inclusion Criteria:

* Female patients in complete remission after chemotherapy for Hodgkin lymphoma
* Age ≥ 18 e \< 40 years
* Previous regular menstrual cycle
* No previous or concomitant gynecological diseases affecting reproducing function
* No other chemo-radiotherapy for other neoplasm
* Written informed consent

Exclusion Criteria:

* none
Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma

In patients at risk of increased intracranial pressure (ICP), ICP measurements require invasive transducers, usually with insertion of a catheter into the cranium, or through a spinal tap. These invasive modalities involve risks and pain and they can be done only in specialized care units, with a high associated cost.

A novel method for detecting changes in ICP has developed recently. The auditory hair cells emit sounds and electric signals in response to sound, which can be easily detected and measured non-invasively with the help of a microphone probe placed in the external ear canal or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF) spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within seconds.

A symptom of intracranial pressure (ICP) was observed in glioma patient due to a combination of causes: the inflammatory reaction around the tumor, the mass effect of the tumor, secondary vascular changes, a change in the flow of CSF.

The evaluation of intracranial hypertension by increased ICP (invasive) is not used in the monitoring of intracranial tumors. It is then detected by using routine clinical signs, in combination with a standard imaging method (MRI), but still subjective.

The measurement of noninvasive ICP could allow earlier detection of relapse, and evaluate whether the increase in ICP precedes tumor clinical worsening and / or imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant glioma who underwent a biopsy or a partial surgery of this tumor and a radiotherapy and/or chemotherapy treatment.
* Valid tympanometry test at least for one ear
* Between 18 and 65 years of age
* Cochlear response useful at least for an ear which has validate the tympanometry test
* Written informed consent reviewed and signed by patient
* Affiliation to a social security scheme

Exclusion Criteria:

* Patients who underwent a complete resection of their malignant glioma
* Invalid tympanometry test for the both ears
* Collect of cochlear responses impossible for the ear or both ear which validate the tympanometry test
* Patient refusal after enlightened information
Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm

Observational, prospective, cohort study to evaluate, by an opportunistic screening program based on vascular ultrasound, the prevalence and characteristics of Abdominal Aortic Aneurysm (AAA) and Popliteal Artery Aneurysm (PAA) in a female population as well as the prevalence and characteristics of PAA in male population.

Abdominal aortic aneurysm (AAA) remains a highly topical issue given the potentially dramatic consequences associated with its rupture. In men, the prevalence of AAA is declining, probably due to improved management of risk factors. However, the most recent studies and international recommendations have reaffirmed that screening for AAA in men is still important and cost-effective. In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated. For this reason, the recommendations are contrasting and not univocal. About 35% of patients with AAA have a second aneurysm more distally. Popliteal artery aneurysm (PAA) is the most common. Like AAA, PAA is often asymptomatic and its main complication is thrombotic occlusion resulting in acute/chronic ischemia of the affected limb and a high prevalence of permanent sequelae (mainly amputation). Data on epidemiology and risk factors of PAA are very limited in men and absent in women. In addition, the benefit of PAA screening has never been assessed so far.

The aim of this study is to evaluate, by an opportunistic screening program based on vascular ultrasound, the prevalence and characteristics of AAA and PAA in a female population as well as the prevalence and characteristics of PAA in male population. The project represents the first screening program for popliteal aneurysm. Finally, the results will allow us to better assess need for and modalities of a screening program.

Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥65 years who are current smokers
* Men aged ≥65 years
* Women or Men aged ≥55 years with family history (first-degree relatives) for Abdominal Aortic Aneurysm (AAA) or popliteal artery aneurysm (PAA)

Exclusion Criteria:

* Patient with known diagnosis of AAA or PAA
* Patient already operated for AAA or PAA
* AAA/PAA screening or arterial assessment of lower limbs within the last 12 months
* Inability to understand and/or sign study consent
* Inability to access follow-up controls
Conversion of Evidence and Applied Research on Intermittent Catheterization After Radical Hysterectomy

In this study, the investigators summarize the existing best evidence of intermittent catheterization in patients after radical cervical cancer surgery from the perspective of clinical translation of evidence through systematic search, evaluation and evidence integration, construct a nursing protocol of intermittent catheterization for patients after radical cervical cancer surgery based on the best evidence combined with the clinical context, and explore the clinical application effect of the above nursing protocol. It will provide a reference basis for the development of the standardization and management of intermittent catheterization for postoperative patients with cervical cancer in China, as well as the development of guidelines for intermittent catheterization after radical cervical cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 18 years old
* Radical cervical cancer surgery and intermittent catheterization were performed at the Institute's hospital
* Patients or their family members can operate a smartphone
* No cognitive or psychiatric disorders, and can communicate effectively

Exclusion Criteria:

* People with serious heart, brain, lung and other important organ diseases
* People with water, electrolyte, acid-base balance disorders at the beginning of intermittent catheterization
* People with previous serious renal diseases, bladder and urethra surgery
* People with urinary tract infections
* People who did not complete all interventions or data collection
* People who voluntarily withdrew from the study or died during the study period;
* Refuse to participate in this study