cyrilzakka/clinical-trials huggingface dataset:
Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder

Vestibular stimulation has been shown to be a very effective noninvasive treatment for major depression. Bipolar disorder is a mental illness that presents cyclic sequences of depressive and euphoric states. Depressive phases of bipolar disorder are difficult to treat and usually are resistant to actual available treatments. This study investigates the effectiveness of a particular technique of vestibular stimulation in a group of 120 bipolar type I and II patients. After randomization 60 of them will receive specific vestibular stimulation (experimental group) and 60 will receive a sham vestibular stimulation.The study will conducted in Vest Brain, Centro de Estudios Neurovestibulares, in Chile.


Eligibility Criteria:
Inclusion Criteria:

* males
* females
* 3 previous weeks with depression symptoms.
* bipolar disorder type I actual depressive phase
* bipolar disorder type II actual depressive phase
* Montgomery Asberg depression scale(MADRS) score equal or more than 20
* stable psychiatric medication during 2 weeks previous the recruitment

Exclusion Criteria:

* pregnancy
* neurologic disorder
* drugs or alcohol abuse during the 2 weeks previous the recruitment
* presence of maniac state(Young mania scale score more than 7)
Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudy

The Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS 1) is designed to systematically collect and document use patterns, effectiveness, and safety of DMARD treatments currently used in the management of rheumatoid arthritis (RA). It is anticipated that study data may help improve the quality of information upon which clinical decisions are based.


Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of the 1987 American Rheumatism Association criteria for RA
* Currently requiring a new DMARD (change or addition)

Exclusion Criteria:

* Currently enrolled in a clinical trial with treatments or patient visits imposed by a protocol
* Nursing or pregnant women
* Patients with active infection
Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification

The aims of this study are:

1. to explore a novel 2D-Cardiovascular magnetic resonance (CMR) indirect method for tricuspid regurgitation (TR) quantification (ATRIAL method) relying on right atrium variables, and assess its agreement with the traditional indirect method (involving right ventricle variables) and the direct method (based on through-plane phase contrast (PC) sequences on the tricuspid valve);
2. to assess the agreement of TR volume (RVol) and regurgitant fraction quantification from 2D-CMR methods with transthoracic echocardiography and 4DF-CMR methods;
3. to assess the diagnostic performance of 2D-CMR in classifying TR, in terms of RVol and regurgitant fraction, with respect to echocardiographic transthoracic echocardiography grades.


Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥ 18 years with the diagnosis of al least mild-degree tricuspid regurgitation, who:
* patients that are scheduled for a Cardiovascular Magnetic Resonance examination in our Institution

Exclusion Criteria:

* Patients with previous surgical or transcatheter interventions on the tricuspid valve
* Patients with Ebstein's disease
* Subjects with pace-maker or intracardiac defibrillator
* Subjects with intrabody ferromagnetic material precluding patient's safety
* Patients with claustrophobia or breath-holding precluding an adequate CMR images quality
* Pregnant women
Effect of Treatment Dairy for Spasticity

1. Assessing whether the treatment diary can help optimize the overall treatment of patients.
2. To assess whether the patient finds the treatment diary useful and worth spending time on. Also if the patient finds it easier to evaluate the treatment and, if necessary, set new goals.
3. To assess whether the patient's quality of life is increased by the use of the treatment diary.

Hypothesis:

A treatment diary will increase the patient's awareness of which spasticity symptoms are significant and can enable the patients to evaluate the treatment more easily.

This will result in more relevant treatment goals. At the same time the treatment can be better addressed to the individual patient at routine controls. In addition, the treatment diary will result in closer cooperation between the physiotherapists and occupational therapists and the physician who administers the botulinum toxin. This collaboration is expected to lead to better common goals and optimization of treatment.

Finally, it is expected that the above will help to increase the patient's quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have received at least two previous treatments before inclusion, ie. with approx. 3 months apart, and it is assessed that the patients have good effect of the treatments in relation to the agreed treatment goals.

Exclusion Criteria:

* Patients where changes are planned regarding their treatment for muscle overactivity during the study period.

Patients where the disease is not stable and where it may have a major influence on the treatment effect of botulinum toxin treatment during the study period and where it can be difficult to set SMART (Specific, Measurable, Accepted, Realistic, Timed) goals.

Patients who have previously been treated and have used a treatment diary in connection with the botulinum toxin treatment.

Patients who can not collaborate on completing goals and evaluating treatment effect due to language or cognitive problems.

Patients who at the same time are being treated with botulinum toxin in the bladder.

If significant changes occur in the patient's health, which may involve new cancer, stroke, multiple sclerosis attack, etc. during the study period, the participant will be withdrawn from the study.
Internet-Based Self-Help Intervention for Social Anxiety Symptoms

This study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. Participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist.

The intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in Turkey. Participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides.

This study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. Participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist.

The intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in Turkey. Participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides.

The intervention program consists of five modules. Each module can be completed in 30-40 minutes. Each module starts with the evaluation of the exercises given at the end of the previous module and ends with a between-module exercise. The module includes text, interactive forms, animated videos, audio recordings, and images.

The duration of the program will be approximately five to seven weeks. However, participants will be allowed to follow the program at their own speed. No limitations will be imposed other than the completion of no more than one module per day. Users can use the system with their e-mail addresses and passwords.

The data will be compared with suitable statistical techniques.

Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in the study;
* having a valid e-mail address;
* having internet access (computer, laptop, tablet, or mobile device);
* being aged 18 or older;
* score of 25 or above on both anxiety and avoidance subscales of the Liebowitz Social Anxiety Scale Turkish Form

Exclusion Criteria:

* receiving any psychological help (i.e., medication or psychotherapy/counseling) during the research period
MDR ExploR Radial Head System PMCF

The objective of this retrospective and prospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the ExploR Radial Head System (implants and instrumentation) when used for radial head arthroplasty.

This is a global, multi-center, retrospective enrollment, prospective follow-up, consecutive series post-market clinical follow-up study. The intent of the study is that subjects who have already had the surgical implant will be retrospectively enrolled in the study and data will be collected for a minimum of 10 years post-operatively. Subjects treated with the device will be identified and invited to participate in the study. 93 subjects will be enrolled into the study.

Eligibility Criteria:
Inclusion Criteria:

Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication, which includes the following:

* Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

Joint destruction and/or subluxation visible on x-ray Resistance to conservative treatment

* Primary replacement after fracture of the radial head
* Symptomatic sequelae after radial head resection Patient must be 18 years of age or older. Patient must be willing and able to follow directions.

Exclusion Criteria:

* Infection
* Sepsis
* Osteomyelitis
* Uncooperative patient or patient with neurological disorders who are incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Patient is a prisoner.
* Patient is a current alcohol or drug abuser.
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
* Patient is known to be pregnant or breastfeeding.
* Patient is unwilling to sign informed consent.
Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
* Willing to wear a CGM at least 70% of the time while in the study
* Willing to wear an Apple watch on their dominant hand while awake
* Missing or late in giving at least four food boluses in the previous 2 weeks
* Understanding and willingness to follow the protocol and sign informed consent

Exclusion Criteria:

* Pregnant or lactating women
* A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
* Current treatment for a seizure disorder
* Inpatient psychiatric treatment in the past 6 months

Subject may participate in another trial if it is approved by the investigators of both trials.
Evaluation of Tumor Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography in Patients With Sarcoma

This study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal.

PRIMARY OBJECTIVE:

I. To evaluate the use of indocyanine green (ICG) as an intraoperative guide during bone and soft tissue sarcoma resection.

OUTLINE: This is an observational study.

Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection

Exclusion Criteria:

* \* Age less than 18

  * Chronic kidney disease
  * Anaphylaxis to dyes
The Early Origins of Cardiovascular Disease

Small body size at birth, slow weight gain during infancy and increase in body mass index after 2 years are independent risk factors for cardiovascular disease and the metabolic syndrome. There is a large gap in our understanding of how early growth affects the cardiovascular system. Possible mechanisms include alterations in body composition, in cardiac structure, in vascular function, in renal function and epigenetic processes.

The Objective is to determine how size at birth and growth during infancy and childhood affect: body composition, cardiac structure and function, vascular and endothelial function, renal function, metabolic status and transcriptional and epigenetic characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers students aged between 18-25 years old
* Having growth records

Exclusion Criteria:

* If young women subject without contraception,or pregnant
The Effect of Breastfeeding Education on Breast Milk Perception and Self-Efficacy in the Pregnancy Health Belief Model

Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk.

Introduction: It is known that breast milk is crucial for newborns and infants. The Health Belief Model has been widely used in recent years to improve and promote health behaviors.

Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk.

Method: This randomized controlled study was conducted between June 30, 2022, and December 31, 2022, at the Dr. Selahattin Cizrelioğlu State Hospital in Şırnak. A total of 220 participants, including 110 couples who met the inclusion criteria, were randomly assigned to an intervention group (55 couples) and a control group (55 couples). Data were collected using a "Participant Information Form" for socio-demographic and obstetric information, the "Adults' Perception of Breast Milk Scale" for assessing perception related to breast milk, the "Pregnancy Breastfeeding Self-Efficacy Scale- Short Form" for evaluating mothers' breastfeeding self-efficacy during the antenatal period, and the "Paternal Breastfeeding Self-Efficacy Scale" for assessing fathers' breastfeeding self-efficacy during the pregnancy period.

Eligibility Criteria:
Inclusion Criteria:

* Those aged 18 and over
* Living in the same house with his/her spouse
* Able to speak and understand Turkish
* In the 27th week of pregnancy and above
* Having a first pregnancy
* Using a phone
* Couples willing to participate in the research

Exclusion Criteria:

* multiparous
* Receiving psychiatric or neurological treatment that affects cooperation and cognitive functions
mHealth Physical Activity Trial for Older HIV-infected Adults (mFIT)

This pilot study will examine the effect of a mobile health text messaging platform linked to a digital physical activity tracker on physical activity among persons living with HIV and frailty.

HIV is associated with frailty, an important aging-related phenotype associated with adverse clinical outcomes. The investigators propose that personalized health coaching using a digital activity tracker with mobile health text messaging can increase physical activity in this population. The total duration of the intervention will be 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 positive adults of any gender
* Age 50 years and older
* Frailty score of 2 or greater (at least 1 criteria is slow gait speed or decreased grip strength)
* Ability to provide informed consent

Exclusion Criteria:

* Any physical condition that would prevent or prohibit moderate physical activity
* \>3 days per week of moderate or vigorous leisure time activity lasting \>30 min/day
Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation

Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18
* Liver transplant recipients
* Treated with an immunosuppressive protocol with tacrolimus
* Informed on the study and who did not refuse to participate

Exclusion Criteria:

* Patients who participate in a study with procedures incompatible with the present study.
* Patients with legal protection/deprived of liberty.
A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients With CD4 <= 500 Cells/mm3

To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).

This is an open-label, randomized, pilot, Phase II study of the safety and efficacy of Viracept in combination with modified antiretroviral therapy as treatment in patients with cutaneous and mucosal KS. Patients will be randomized to modify (add or switch or initiate) their current antiretroviral therapy and will add Viracept or remain on their current background antiretroviral therapy for a 2 month period. Initially 20 patients will be randomized in a 2:1 ratio (i.e., 14 Viracept, 6 control) for a 2 month period. Response to therapy will be evaluated at the end of the 2 month control phase. At this point, patients who were initially assigned to the control arm will continue on open label Viracept for an additional 10 month period.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-positivity.
* Diagnosed KS proven by biopsy.
* NOTE:
* Patients must not opt for immediate topical, systemic or radiation treatment.
* At least 4 cutaneous lesions not treated within the previous 4 weeks.
* Life expectancy \> 6 months.
* Signed, informed consent from parent or legal guardian for those patients \< 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

* Neoplastic disease (excluding KS) requiring systemic cytotoxic or radiation therapy or who have had these therapies within 1 month of baseline and have not completely recovered from the effects of these therapies.
* Unstable or severe intercurrent medical conditions, including but not limited to, significant symptomatic visceral KS.
* Clinically significant malabsorption syndrome.
* Renal insufficiency.

Patients with any of the following prior conditions are excluded:

Significant Fever (\> 101 degrees F (38 degrees C) for \>= 7 days) and/or diarrhea (\> 6 loose stools/day for \>= 7 days) within one month of baseline.

1. Immediate topical or systemic treatment for KS lesions.

* Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day concurrently.

Immediate radiation treatment.

1. Treatment of KS lesions with intra-lesional chemotherapy within 4 weeks of entry.

* History of \> 2 weeks of prior therapy with Indinavir or Ritonavir.
* Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day within 4 weeks of entry.

Treatment of KS lesions with radiation within 4 weeks of entry. Active substance abusers; urine drug tests may be performed if drug abuse is suspected.
Vessel Resection and Reconstruction of Biliary Tract Cancers

To investigate the vessel resection and reconstruction in biliary tract cancer.

The vessel resection and reconstruction of hepatic artery and portal vein in biliary tract cancer surgery is still controversial. In this study, we retrospectively evaluate the diagnostic image, pathology, peri-operative events, recurrence, and prognosis in these patients, as a multi-center surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Cases of vessel resection and reconstruction in biliary tract cancer.

Exclusion Criteria:
Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors

The purpose of this study is to verify if adding a locoregional treatment of liver metastasis (with trans-arterial embolization-TAE) to medical treatments of proven efficacy can prolong the progression free survival of patients affected by neuroendocrine tumors (NET) with inoperable liver metastases


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NET of gastroenteropancreatic (GEP), pulmonary or unknown primary site origin
* Unresectable liver metastases, according the judgment of surgeon, (the reasons for the opinion of surgeon should be made explicit)
* Hepatic involvement ≤50% volume of the organ
* Radiological evidence of hepatic lesions (contemporaneous progression or appearance of extrahepatic lesions are allowed if not critical sites) that require change or initiation of systemic pharmacotherapy
* Patients undergoing , previously treated , or never treated with systemic medical therapy are eligible
* Patients with or without carcinoid syndrome are eligible
* Well (G1) or medium (G2) differentiated histology (according to WHO 2010 classification)
* Ki67 ≤ 20% (G1-G2)
* Life expectancy \> 6 months
* Age ≥ 18 and \< 80 years

Exclusion Criteria:

* Previous loco-regional post-surgical treatment
* Poorly differentiated histology
* Severe concomitant morbidities such as: severe coagulopathy, severe liver failure (to be detailed), renal failure (creatinine \> 2.0 mg/dl) and heart failure (NYHA 3-4 or unstable ischemic heart disease), contraindicating the interventional procedure or influencing the general prognosis (Investigator to provide details of exclusion)
* Extrahepatic metastasis in critical locations as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions
* Patients with only extra-hepatic lesions