cyrilzakka/clinical-trials huggingface dataset:
Hip Viscosupplementation: What is the Best Dosage?

Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to determine the optimal dosis for hip viscosupplementation

Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. Any osteoarthritic joint is eligible to this treatment modality, but the great majority of studies are for knee viscosupplementation. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. We will prospectively enroll 80 patients with hip osteoarthritis and will randomize them into four groups: Group zero will receive joint lavage with saline injection. Group 1 will receive joint lavage with saline injection and 2 ml of Hylan GF-20 (1 ampoule of Synvisc Classic®). Group 2 will receive joint lavage with saline injection and 4 ml of Hylan GF-20 (2 ampoules of Synvisc Classic®). Group 3 will receive joint lavage with saline injection and 6 ml of Hylan GF-20 (3 ampoules of Synvisc Classic®). The Visual Analogic Scale of Pain (VAS), the Western Ontario and McMaster Universities Index (WOMAC®), and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24. Our objective is to determine the optimal dosis for hip viscosupplementation

Eligibility Criteria:
Inclusion Criteria:

* Met the American College of Rheumatology criteria for hip osteoarthritis
* No hip intraarticular injections in the last 6 months

Exclusion Criteria:

- Severe reaction to the procedure
MSC Therapy in Liver Transplantation

The general aim of the present study is to test a cell therapy with third-party allogeneic ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. MSCs will be prepared accordingly to established protocols , starting from diagnostic samples of bone marrow aspirates (2-5 mL) or using the remnants in the bag and filter at the end of the bone marrow infusions. From these samples, MSCs will be expanded in GMP approved facilities and used for the present study in patients undergoing liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

For this study, the following inclusion criteria should be fulfilled before starting withdrawal of drugs after 1 year post-transplant:

* First liver transplant
* Capable of understanding the purpose and risk of the study
* Written informed consent

Exclusion Criteria:

* Specific contraindication to MSC infusion
* Any clinical relevant condition that might affect study participation and/or study results
* Pregnant women and nursing mothers
* Unwillingness or inability to follow the study protocol in the investigator's opinion.
The Effect of Digital Storytelling Applied to Children in Preoperative Period

Digital storytelling is the craft and art of exploring different media and software applications to communicate stories in new and powerful ways using digital media. Because new digital tools are inexpensive and widely available, digital storytelling tends to be highly personal and at the same time universal. All in all, it is a very powerful form of communication. Digital storytelling applications include short (three to five minute) films with pictures, video clips, soundtrack and narration; storytelling performances and talks supported by media slideshows or interactive presentations; and web-based applications, including streaming media, podcasts, and blogs.

When looking at the literature, different approaches to using digital storytelling are seen: it is used in the education of health professionals, in academic education, for digital story development and research, and as a therapeutic care intervention.

Studies on the use of digital stories in the field of health have just begun to gain popularity, and it is noteworthy that the studies in the health services literature are not yet at the desired level and prevalence. Healthcare is a unique environment to use digital storytelling intervention as a therapeutic purpose in addition to gaining knowledge in all our activities. Using digital stories; It is thought that it will provide significant benefits to parents/children and health professionals by filling the gap in the literature in order to reduce the negative emotional behaviors and anxiety of children undergoing day surgery in the preoperative period, as an informative intervention that can attract the attention of their children while having fun.

The type of study planned is randomized controlled experimental design. The study group is divided into two as intervention and control groups. The intervention and control groups will be selected by simple random sampling method from among the volunteer participants who meet the inclusion criteria. Power analysis was performed to determine the sample size. It was observed that the effect size obtained in the reference study (Chow et al. 2017) was quite strong (d=0.96). As a result of the power analysis we performed, assuming that a lower level of effect size could be obtained (d=0.8), it was calculated that 80% power could be obtained at the 95% confidence level when at least 52 people (at least 26 people for each group) were included in the study. Considering that there may be data losses, the sample size was planned as 72 people (36 people for each group), taking approximately 30% more than the number of samples calculated as a result of the power analysis.

Eligibility Criteria:
Inclusion Criteria:

Admission to hospital for day surgery Having internet Access Written informed consent from family and volunteers to participate in the study

Exclusion Criteria:

Children with neurological development and learning problems Children with chronic illness who require special medical care No internet Access
Single Rising Dose Tolerability Study of BIBN 4096 BS in Healthy Male and Female Volunteers

The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing doses in healthy male and female volunteers


Eligibility Criteria:
Inclusion Criteria:

* Participants should be healthy males and females
* Age range from 21 to 50 years
* Within +- 20% of their normal weight (Broca-Index)
* All female volunteers must use a safe contraception (i.e. oral contraceptive, spiral; sterilized) and must have a negative pregnancy test
* In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
* Each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead Electrocardiogram (ECG) within 14 days before the first administration of the test substance
* Haematopoietic, hepatic and renal function test will be carried out in the laboratory
* The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations

Exclusion Criteria:

* Volunteers will be excluded from the study if the results of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections (especially common cold with rhinitis)
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\>= 24 hours) within ten half-lives of the respective drug before enrolment in the study
* Use of any other drugs which might influence the results of the trial during the week previous to the start of the study
* Participation in another study with an investigational drug within the last two months preceding this study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 40g/day)
* Drug abuse
* Blood donation ( \>= 100 ml) within the last 4 weeks
* Excessive physical activities (e.g. competitive sports) within the last week before the study
* Pregnant and/or lactating volunteers
Brief Interventions on Smoking for Hormonal Contraceptive Users

Despite rising smoker rates, particularly in girls and young women, only few studies have focused on smoking cessation in young smokers. Gynaecologist practices may be an ideal setting to proactively intervene with young female smokers. Elevated health risks of smoking while using hormonal contraceptives could be a successful approach to gain young women's attention on smoking cessation. The purpose of this study is to evaluate the effectiveness of a smoking cessation intervention for girls and young women visiting gynaecologist practices and using hormonal contraceptives.

In the randomized controlled trial, female smokers aged 14-25 will be recruited in practices of gynaecologists. Intervention within the practice consists of a 30 minutes counseling session based on Motivational Interviewing, a standardised physician letter focusing on the elevated health risks of smoking while using hormonal contraceptives and a stage-matched self-help manual. After four weeks, an expert system feedback letter will be sent. In the intervention group, no smoking intervention will be given. Follow-up assessments will be conducted after 12 months, including saliva cotinine measures.

Eligibility Criteria:
Inclusion Criteria

* Age 14-25
* Having smoked at least 1 cigarette within last 4 weeks
* Use of hormonal contraceptives or intention for prescription within next 2 weeks

Exclusion Criteria:

* Pregnancy
* Emergency treatment
Does the Use of Fiasp vs. Asp Lead to the Prolonged TIR in Children With Type 1 Diabetes?

The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.


Eligibility Criteria:
Inclusion Criteria:

* ≥1 year of a history of type 1 diabetes;
* treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, CSII) ≥3 months;
* using continuous glucose monitoring system for at least 1 month;
* HbA1c\<8%;
* consent to participate in the study obtained from the parent and the patient (\>16 years of age).

Exclusion Criteria:

* diabetes treated with multiple insulin injections with insulin pens (Multiple Daily Injections, MDI);
* concomitant medical problems which might significantly affect glucose levels;
* the withdrawal of the consent to participate in the study.
Memantine for Enhanced Stroke Recovery

This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and upper extremity weakness are randomized to either drug or placebo

This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and upper extremity weakness are randomized to either drug or placebo, complete therapy, and complete outcomes assessments at baseline, 4, and 12 weeks post-stroke. Target enrollment will be 10 patients per group and adaptive randomization will be used to assist with equal representation of pre-stroke selective serotonin reuptake inhibitor (SSRI) use and motor severity (Fugl-Meyer score) in each arm. The primary purpose of this pilot study is to measure adverse events, drop-out rates, feasibility of trial conductance, and establishment of effect sizes in each group in order to power a larger efficacy trial at the University of Utah. An intention to treat model will be used during the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years old
2. Randomization between 3 days-8 weeks days of stroke symptom onset
3. Arm weakness severe enough to warrant inpatient or outpatient occupational therapies
4. Able to voluntarily move affected UE
5. Living independently prior to their stroke
6. Image-confirmed ischemic stroke (MRI or CT)
7. Supratentorial location of stroke
8. Fugl-Meyer Upper Extremity Score of 50 or less and/or Fugl Meyer Lower Extremity Score of 28 or less
9. Ability to swallow pills

Exclusion Criteria:

1. subarachnoid hemorrhage, subdural hemorrhage or other cause of symptoms other than ischemic or hemorrhagic stroke
2. Infratentorial location of stroke (brainstem or cerebellum)
3. NIH Stroke Scale \>20 at the time of randomization
4. History of dementia that will interfere with rehabilitation
5. Pre or post-stroke use of memantine or amantadine
6. Contraindications to taking memantine XR in pill form
7. History of prior clinical stroke with residual symptoms on the same side as the current symptoms that would interfere with outcomes of this study
8. Documented severe renal impairment (CrCl \< 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment if not done as part of clinical care.
9. Moribund or not expected to live 6 months
10. Severe cognitive deficits or pre-morbid function causing inaccurate neurologic assessment or inability to complete the initial assessment
11. Comorbid neurologic disease that would interfere with the results including but not limited to Multiple Sclerosis, neurodegenerative diseases, spinal cord disease, and central nervous system cancer.
12. Documented severe hepatic impairment (Child-Pugh score \> 6) or severe hepatic disease (hepatitis)
13. Patients who are pregnant or breast feeding
Visceral Osteopathy in Functional Constipation

It is a functional bowel disease characterized by excessive straining during defecation, infrequent defecation, and the feeling of incomplete evacuation. There are very few studies investigating the incidence and prevalence of functional constipation.Non-pharmacological treatment methods, including lifestyle changes, are primarily recommended for the treatment of constipation. The aim of the study is to examine the effects of visceral osteopathic approaches on individuals diagnosed with functional constipation and compare them with conventional methods.

Non-pharmacological treatment methods, including lifestyle changes, are primarily recommended for the treatment of constipation. In cases where success is not achieved with this method, pharmacological agents, biofeedback and surgical treatment methods can be applied depending on the severity of constipation. Lifestyle changes include increasing fiber and fluid intake and regular physical activity Osteopathic manual therapy (OMT) is the examination and treatment of the function of the neuromusculoskeletal system anatomy using non-invasive, generally safe manual techniques to improve functional body mechanics such as joint range of motion, muscle tone, circulation, body fluid pressures and exchanges, and nerve impulses. OMT is used for autonomic system regulation, balancing pelvic muscle tone, increasing gastrointestinal motility, preventing myofascial limitations and increasing the pump effect of the diaphragm (5,6). The positive effects of OMT on the microbiome are available in the literature.

Alternative treatments are needed because the costs of combating constipation are high. Non-invasive interventions are especially gaining importance.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer individuals aged 18 and over
* Clinical diagnosis with functional constipation based on ROMA IV criteria

Exclusion Criteria:

* Clinical diagnosis of a gastrointestinal disease other than constipation,
* Undergone abdominal surgery in the last 6 months,
* Having abdominal aortic aneurysm, acute rectal bleeding, malignant mass in the GIS,
* Pregnancy or suspected of pregnancy,
* Cliniclal diagnosis of neurological disease that may cause constipation,
* Expreinced unexplained fever, Individuals with night sweats and weight loss
HIV Risk and Prevention in Women

This study gathers information about HIV testing utilization and influences on HIV testing decisions among young, general population Russian women at-risk of HIV exposure. The study compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in vs. opt-out) and conducts one of the first randomized experimental comparisons of these strategies. The overarching goal is to gain knowledge that can be used to increase utilization of HIV testing among at-risk young women and offer gender-specific strategies for improving prevention.

The study uses an adaptive design. That is, the procedures and phases of the study experienced by a participant depend to some extent on their responses to earlier phases. Ultimately, this design yields a number of practice relevant pathways and endpoints, each of which has a testing rate associated with it.

Phase-I is initial screening for risk status, collecting background data, and ascertaining whether there has been recent independent HIV testing. If there has been independent testing, information about the independent testing is collected and the participant's involvement is complete.

Those who are not independent testers enter Phase-II. Phase II will include: randomization to opt-in vs. opt-out conditions; a survey asking about reasons for acceptance or non-acceptance; participating in a focus group in which participants who have not accepted HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then (5) after the focus group is complete, privately offer another testing opportunity to non-accepters, under the same opt-in or opt-out strategy to which they previously were randomized. The design was selected in order simultaneously answer a number of questions that we believe will be important for engineering a testing and prevention strategy suitable for testing in a subsequent study: (1) identify key attitudes, beliefs and knowledge (survey); (2) contrast opt-in and opt-out strategies (randomized trial); (3) generate qualitative data about reasons for decisions in the women's own words (focus group); and (4) identify any incremental benefit related to peer discussion.

Eligibility Criteria:
Inclusion Criteria:

* The participant's sexual risk behaviors (i.e., a) two or more partners in the last 12 months, or her partner's HIV risk (e.g., HIV positive, no HIV testing and a diagnosis of sexually transmitted diseases in last 12 months, multiple partners, blood transmission, male partners, served in prison, or drug use) and no or inconsistent condom use in the last 3 months, and no HIV testing in the last 12 months, or b) any sexually-transmitted disease and no HIV testing in the last 12 months).

Exclusion Criteria:

* Does not speak Russian, are currently pregnant, have a condition that might preclude a finger-stick procedure, or have tested HIV positive in the past.
Coated Mongolian Aneurysm Treatment Study 1

The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under Dual Antiplatelet Medication.

Title: Observational Registry With p64 MW HPC and p48 MW HPC in Unruptured Anterior Circulation Aneurysms Under Dual Antiplatelet Medication.

Purpose: To assess safety and effectiveness of p64 MW HPC or p48 MW HPC under Dual Antiplatelet Medication in consecutive patients with unruptured anterior circulation aneurysms.

Follow-up intervals: Independent follow-ups (after 3 to 6 months and after 12 months and after 24 months) according to site specific standard.

Eligibility Criteria:
Inclusion Criteria:

* At least one unruptured sidewall aneurysm in the anterior circulation
* No implant (e.g., stent) in the target vessel segment
* Age \>18 years and \<80 years
* Not pregnant and in women of childbearing age, on oral contraception for two years following the procedure
* No participation in another trial
* No concomitant disease limiting the life expectancy to \<2 years
* No allergy to non-ionic contrast medium or to ASA and P2Y12 receptor antagonists
* No other neurovascular disorder in the same vascular territory requiring treatment in the foreseeable future
* Ability and willingness to comply with the medication requirements within the study,
* Ability to understand the goal and risks of this study.

Exclusion Criteria:

* Intracranial aneurysm considered not suitable for FD using p64 MW HPC or p48 MW HPC.
* Aneurysm previously treated with a device in the parent vessel (e.g., stent, flow diverter).
* Another intracranial procedure scheduled for the following 6 months.
* Age \< 18 years and \> 80 years.
* Pregnancy possible or confirmed. Patient not able or willing to arrange contraception for 12 months after treatment.
* Patient not able or willing to adhere to the study protocol.
* Patient not able or willing to undergo the scheduled follow-up examinations.
Evaluation of Various Methods Used to Identify the Proximal Humerus Intraosseous Vascular Access Site

The purpose of this study is to determine if there is one method of identifying the proximal humerus intraosseous vascular access site that is easier for clinicians to use, out of the 4 methods being evaluated.


Eligibility Criteria:
Inclusion Criteria Device Operators:

* Recent/current experience in the medical field as a practicing clinician.
* Currently licensed/certified Emergency Medicine Technician, paramedic, or nurse
* Have had no formal training on use of the proximal humerus intraosseous insertion site.

Exclusion Criteria Device Operators:

There is no exclusion criteria

Inclusion Criteria Healthy Volunteers

* Age 21 years or older.
* Has no amputation of the upper extremities.
* Able to lay flat on table for up to 2 hours.
* Self-reported as healthy.

Exclusion Criteria Healthy Volunteers:

* Have an active infection in the body
* Imprisoned
* Pregnant
* Cognitively impaired
* Fracture in humerus, or significant trauma to the site
* Excessive tissue and/or absence of adequate anatomical landmarks in humerus
* Infection in target area
* Humeral intraosseous insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus
* Current use of anti-coagulants
Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

Aim of the study is to compare in hypertensive patients the effect of one year therapy with ACE-inhibitor (RAMIPRIL) or angiotensin II receptor blocker (IRBESARTAN) on left atrial remodelling and diastolic function.


Eligibility Criteria:
Inclusion Criteria:·

* mild to moderate essential hypertension
* no antihypertensive treatment
* good quality echocardiogram

Exclusion Criteria:

* cardiovascular diseases (AMI, stroke o TIA)
* heart failure, valvular heart disease
* diabetes
* secondary hypertension
* atrial fibrillation
* hepatic and renal severe failure
* pregnancy
Evaluation Conformal Radiotherapy for Gynecologic Cancer

The purpose of this study is comparision conformal radiotherapy for gynecologic cancer


Eligibility Criteria:
Inclusion Criteria:

* Gynecologic cancer

Exclusion Criteria:

* Metastases