cyrilzakka/clinical-trials huggingface dataset:
Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts

The methodology will be applied for the treatment of aggressive episodes. Many people show this kind of behavior associated with several psychological disorders like austistic spectrum disorder (ASD). It will be studied the effect of aggressive outbursts on several physiological signals (heart rate (HR), breathing rate (BR), electroencephalography (EEG), etc). The use of those signals in a biofeedback loop could help patients recognize their internal states and avoid imminent aggression. The study want to verify the efficacy of a cognitive therapy that includes biofeedback and virtual reality (VR) and find out the most significant physiological features that are affected by these episodes.

The first goal is to register the scene together with physiological values before, during and after at least up to four aggressive outbursts at home.

Next an outburst is induced and physiological signals before, during and after the aggressive episode are recorded. After it the participants go to a new relaxation phase for another 10-minute period using the VR.

In following sessions, they are trained to identify their physiological response when they are relaxed and when an outburst is coming. To do that, the VR system receives and shows the physiological information on the virtual scenario.

In following sessions, teenagers are then treated with cognitive, behavioral and emotional self-regulation therapies, which have proven their effectiveness for managing anger and learning positive coping skills. The underlying theory is that people can minimize their negative feelings and behaviors when they are aware of their irrational beliefs and work to change their minds, by focusing on them continuously.

At the end of the experiment, the number of aggressive episodes in the last weeks of the intervention will be measured.

The differences between the new scores, with respect to the initial ones, will be used to assess the efficacy of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of ADHD, Asperger syndrome or oppositional defiant disorder (ODD) combined with a lack of control of their aggressiveness.
* Positive impulsivity result obtained with any of the fol- lowing tests: score lower than 25 in CACIA \[13\], lower than 50 in CAPI-A \[14\], greater than 75 in Stroop \[15\] or greater than 115 in WCST \[16\].
* Intermittent outburst episodes (verbal aggression includ- ing both arguments and temper tantrums, and physical aggression towards self or others) with a frequency of once a week in the two months prior to the beginning of the intervention.

Exclusion Criteria:

* Participants will be excluded if they report (a) current (past month) psychopharmacotherapy, (b) a history of bipolar or psychotic disorder, or (c) a traumatic head injury with a loss of consciousness in excess of 60 minutes.
Impact of 80 W KTP Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia

The purpose of this study is to compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic BPH
* International Score Prostate Symptom (IPSS) of 13 or greater
* prostate volume of 30 to 100 ML
* Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of \>125 mL and a PVR \<350mL
* Able to give fully informed consent

Exclusion Criteria:

* Subjects with histological diagnosis of prostate cancer
* Subjects with history of chronic urinary retention
* Subjects with urethral stricture,
* Subjects with bladder neck contracture
* Subjects with urinary tract infection
* Subjects with prostate volume on TRUS of \>100 mL
* Subjects with suspected neurogenic bladder dysfunction
* Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason
Effect of Kinesio Tape on Neck Pain in Lactating Women

This study will be conducted to investigate the effect of kinesio tape on neck pain in lactating women.

Neck pain is widely prevalent and can be exacerbated by poor posture and prolonged or repetitive positions-both of which are common in lactating mothers. Research shows that a significant percentage of breastfeeding women experience musculoskeletal pain, often linked to specific postures such as the cross-cradle hold. Prolonged forward head posture (FHP) and muscle imbalances in the neck-shoulder region further contribute to mechanical neck pain by placing excessive strain on muscles, joints, and connective tissues.

Kinesio taping (KT) is a non-pharmacological technique aimed at alleviating pain and improving functional movement. By lifting the skin slightly, KT is proposed to enhance local blood and lymphatic flow, reduce nociceptive signals, and stimulate proprioceptive feedback. Multiple studies suggest KT can help correct posture, relieve muscle fatigue, and improve range of motion, thus offering a promising intervention for mechanical neck pain. These benefits are potentially valuable for lactating mothers, who are especially prone to postural stresses and neck discomfort due to the physical demands of breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

* All women are complaining from neck pain.
* Their ages will be ranged from 20 to 30 years old.
* Their body mass index will not exceed 30 kg/m².
* They are medically stable and consented to participate in the study.

Exclusion Criteria:

* Cervical spondylosis.
* Cervical disc prolapse.
* History of fracture of cervical spine.
The Effect of Intraoperative Ventilation Mode on Hemodynamics and Lung Dynamics

In this study, it was aimed to compare the effects of pressure-controlled volume-guaranteed ventilation (PCV-VG) and volume-controlled ventilation (VCV) on lung dynamics and hemodynamics in patients undergoing vertebral surgery in the prone position.

The VCV (volume controlled ventilation) mode is the mode commonly used in general anesthesia practice. In VCV mode, the parameters under control are tidal volume and respiratory rate. In VCV mode, airway pressure changes depending on resistance and compliance. There is a risk of increased airway pressures in this mode.

In PCV-VG (pressure controlled volume guaranteed ventilation) mode, the parameters under control are the peak airway inspiratory pressure and the I/E ratio. It has been shown that peak airway pressures decrease and partial oxygen pressure increase due to decreased inspiratory flow in this ventilation mode.

Both ventilation modes are frequently used in patients undergoing general anesthesia.

In this study, it was aimed to compare the effects of pressure-controlled volume-guaranteed ventilation (PCV-VG) and volume-controlled ventilation (VCV) on lung dynamics (pulmonary peak-plateau pressure, compliance, driving pressure, SpO2 and end-tidal carbon dioxide) and hemodynamics (mean arterial pressure and heart rate) in patients undergoing vertebral surgery in the prone position.

In the study, patients will be randomized and divided into 2 groups after obtaining informed consent forms. If a mode change is required during the surgery, that patient will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo thoracolumbar vertebral surgery in the prone position
* Patients older than 18 years
* Patients younger than 70 years of age
* ASA 1-2 patients

Exclusion Criteria:

* Patients with a BMI \>30 kg/m2
* Patients with a history of chronic pulmonary disease
* Patients with a history of previous thoracic surgery
* Patients with ASA \>3
* Patients who will undergo emergency surgery
* Pregnant patients
HIV Prevention Preparedness Study in Russia, China, and India

The purpose of this study is to set up a system for doing research on HIV prevention in various parts of the world.

In order to plan large, long-term studies on the prevention of HIV in different areas of the world, it is necessary to get certain information first. It is important to know about the rate of HIV infection and how to get people to enroll for any future studies. This study will be done at 4 study locations.

In order to realistically plan for future Phase III studies on HIV prevention, information must be obtained to characterize study population parameters at HTPN sites. Very different study designs may be required depending on these parameters, such as the ability of HPTN research centers to recruit study participants and the rate of HIV incidence observed in study populations. This study will be conducted at 4 HPTN sites to establish the necessary research knowledge and infrastructure.

This study enrolls participants from St. Petersburg, Russia; Xinjiang and Guangxi, China; and Chennai, India who are at high risk for HIV infection due to sexual and/or drug use behaviors. Participants who meet the screening criteria then complete an HIV risk assessment interview, receive HIV pre-test and risk reduction counseling, and undergo phlebotomy for HIV antibody testing. Participants who test positive are referred to available services and studies. Those who test HIV-negative and meet eligibility criteria are enrolled and maintained in follow-up over the next 12 months. Participants complete "locator contacts" at Months 3 and 9 and have follow-up visits at Months 6 and 12 for similar tests as performed at entry. In a substudy of this trial in China, participants will be interviewed about their drug use, social networks, needs, and perceptions about HIV/AIDS. These results will be used by HPTN to design more culturally sensitive and appropriate trials in the future.

Eligibility Criteria:
Inclusion Criteria

Participants may be eligible for this study if they:

* Are 16 (Saint Petersburg) or 18 (Xinjiang, Guangxi, and Chennai) years of age or older.
* Are HIV sero-negative.
* Are available for 12 months of study participation.
* Have written consent of parent or legal guardian if under age.
* Are able and willing to provide information on where they can be located or contacted.
* Meet specific risk-group requirements, for women at heterosexual risk, for men at heterosexual risk, and for injection drug users.

Exclusion Criteria

Participants will not be eligible for this study if they:

* Have any mental disorders that would cause a problem with the informed consent or study participation.
* Have any condition that, in the opinion of the doctor, would interfere with the study.
A National Registry on Chinese Patients With Cystic Fibrosis

Cystic fibrosis (CF) is a rare autosomal recessive disease involving multiple organs, especially the lungs and digestive organs. It is most commonly seen in Caucasians. Only a few Chinese CF patients have been described in literature, taking into account the large population of China. The main objectives of this study are to accurately evaluate the prevalence of CF, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in China.


Eligibility Criteria:
Inclusion Criteria:

Fulfilled WHO clinical diagnostic criteria for CF; Was in a stable phase with no respiratory infections for nearly 4 weeks; Subjects (or their guardians) signed informed consent.

Exclusion Criteria:

Patients with other bronchiectasis who did not meet the inclusion criteria; Those with severe cardiac or renal disease
A Cancer Vaccine (CG8123) Given With and Without Cyclophosphamide for Advanced Stage Non-Small Cell Lung Cancer (NSCLC)

The main purpose of this research study is to determine if a vaccine made from a patient's lung cancer tumor cells will be effective in making the cancer shrink or disappear. The vaccine will be given by itself to some patients, while other patients will get the vaccine with cyclophosphamide (a type of chemotherapy). Studies in animals and other cancer vaccine trials suggest that cyclophosphamide may make tumor vaccines more potent. This study will try to determine if vaccine given with or without this chemotherapy is effective in destroying lung cancer cells. Additionally, the study will collect information on vaccine safety, both with and without chemotherapy, and whether the vaccine improves lung cancer-related symptoms (e.g., shortness of breath).

Tumors from surgical resection will be processed and made into a vaccine. Prior to treatment, patients will be randomized equally to one of two treatment groups, Cohort A and Cohort B. Patients in Cohort A will be treated with CG8123 vaccine only and patients in Cohort B will be treated with CG8123 vaccine plus a single dose of cyclophosphamide administered one day prior to the first, third, and fifth vaccine treatments. Patients will receive intradermal (beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of up to five vaccine treatments. The duration of this study, including active follow up, is approximately two years. After this, patients will be followed-up yearly for a total of 15 years.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Suspicious diagnosis of or histologically- confirmed stage IIIB or IV non small-cell lung cancer
* Accessible and adequate tumor source for vaccine production.
* Tumor source for vaccine production must be accessible by a minor surgical procedure performed under local or regional anesthesia (e.g. lymph node or soft tissue mass or malignant pleural effusion)
* Measurable disease to evaluate following tumor procurement
* Limited metastatic tumor burden
* Life expectancy at least 4 months
* ECOG Performance Status 0 - 1

Exclusion Criteria:

* Active and/or untreated brain metastases
* Active or impending spinal cord compression
* Active auto-immune disease or treatment with immunosuppressants
* Decompensated congestive heart failure or recent significant cardiac event
* Coexisting malignancies
* Significant or uncontrolled medical problems or laboratory abnormalities that might increase the risk of surgical complications or vaccine treatment
* Previous treatment with gene therapy (including any adenoviral-based therapy)
Safety and Effectiveness of Computer Screening for Intimate Partner Violence

The purpose of this study is to see if using a computer kiosk to screen men and women for intimate partner violence victimization and perpetration is safe and effective. We hypothesize that screening will not result in any adverse events.

All eligible ER patients will be screened during study times for IPV victimization and perpetration. All victims will be followed at 1 week and 3 months to determine any adverse outcomes. Perpetrators will only be followed in the ED for adverse outcomes after screening. All patients who disclose IPV victimization or perpetration will get a list of community resources. Victims will be asked at follow up what resources they used.

Eligibility Criteria:
Inclusion Criteria: Men and women age 18-55 who present to the emergency department waiting room during study hours

-

Exclusion Criteria:

* Acutely intoxicated, psychotic, unable to read, not English speaking
DASH-Sodium Trial in Adolescents

The Camp DASH study trial will compare the effect of two dietary patterns and two levels of sodium intake on blood pressure and blood lipids in adolescents in the upper third of distribution for blood pressure. The two dietary patterns are based on the Dietary Approaches to Stop Hypertension (DASH) trial in adults.

The Camp DASH study is a controlled trial. the aim of which is to compare the effect of two dietary patterns and two levels of sodium intake on blood pressure and blood lipids in adolescents in the upper third of distribution for blood pressure. The study also assesses whether influences on blood pressure and blood lipids of dietary interventions vary according to sex, race/ethnic groups, baseline levels, and other personal characteristics. The proposed dietary interventions of DASH dietary patterns and sodium reduction have been shown to be effective in lowering blood pressure in adults. The two dietary patterns are based on the Dietary Approaches to Stop Hypertension (DASH) trial in adults. They are a Usual diet typical of what many American adolescents eat, and a DASH-type diet. The DASH diet is rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat compared to the Usual diet. The two sodium levels are High reflecting current US consumption and Low reflecting current recommended intake levels. Weight will be held constant by adjusting energy intake. The study participants will live in a residence hall on the Purdue campus where all food and beverages will be provided, and meals and snacks will be supervised.

Eligibility Criteria:
Inclusion Criteria:

* White, black, Hispanic, and Asian
* SBP in the upper one-third of the distribution for their given sex, age, and height

Exclusion Criteria:

* Pre-existing lipid disorders, abnormal liver or kidney function
* Taking medications that alter mineral absorption or metabolism, affect blood pressure or lipids
* If subjects are taking dietary supplements and refuse to discontinue them 2 months prior to the study.
* Taking non-prescription illegal drugs, smoke, or drink alcohol
* Pregnancy
* Carry an epi pen for food-related allergies
Embolic Events Detected During Total Knee Arthroplasty With the Use of RIA (Reamer-Irrigator-Aspirator)

The embolisation of fat and bone marrow during long bone instrumentation is a well-known complication of major joint replacement surgery. Clinically significant venous thromboembolic disease, cardiopulmonary dysfunction,cerebral emboli, and death have all been described. Because the intravasation of medullary contents is caused by increased pressure during canal instrumentation, the use of the Synthes RIA (Reamer-Irrigator-Aspirator), a negative pressure-irrigated high-speed reamer, may result in a lower incidence of embolism.

This controlled clinical trial will evaluate the utility of the RIA in reducing the frequency and severity of embolic events as detected by intraoperative transesophageal echocardiography (TEE) and transcranial Doppler (TCD) during total knee arthroplasty (TKA) surgery.

Patients scheduled to undergo total knee replacement surgery will be randomized to receive reaming with either the Synthes RIA (intervention group) or standard reamer (control group). All subjects will undergo intraoperative monitoring with transesophageal echocardiography and transcranial Doppler ultrasound. Both intraoperative and postoperative oxygen saturation levels will be monitored and recorded for evidence of hypoxemia. Subjects will be evaluated for evidence of thrombogenesis and systemic inflammation both preoperatively and at selected postoperative intervals.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older
* Scheduled or soon to be scheduled for elective total knee replacement surgery
* No previous history of hip or (ipsilateral) knee replacement

Exclusion Criteria:

* Subject is under 18
* Prior instrumentation of the medullary canal (knee or hip)
* History of esophageal or GI disease or other contraindication for TEE
* Previous history of DVT
* Currently on anti-coagulant therapy (i.e. Coumadin or others)
* Currently on supplemental oxygen or SpO2 is below 90 on room air
* Cognitive or language barriers limiting comprehension of study materials in English
* Subject is pregnant or planning pregnancy
* Current or impending incarceration
Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators.

In particular, main objectives are to compare:

1. the success rates of TRA and TFA including crossing over events between techniques
2. the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
3. access-related adverse events
4. patient preference and reported discomfort

Hepatic arterial chemoembolization is a safe, proven, and effective technique for the treatment of a number of malignancies, including primary and secondary tumors \[1, 2\]. This endovascular treatment is performed via femoral artery access in most cases. In the last decades, the transradial approach (TRA) has emerged as a valid alternative to the transfemoral approach (TFA), and it is commonly used in coronary angioplasty as well as stent placement. In particular, shorter monitoring time after the procedure, earlier ambulation, shorter hospital stay and less discomfort associated with potentially reduced bleeding risks make TRA an attractive alternative to TFA.

To date, only one study exists comparing TRA vs TFA in liver embolizations \[3\]. However, it is non-randomized and reports only the outcomes of one operator performing lobar embolization for multiple liver malignancies.

The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators.

In particular, main objectives are to compare:

1. the success rates of TRA and TFA including crossing over events between techniques
2. the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
3. access-related adverse events
4. patient preference and reported discomfort

Eligibility Criteria:
Inclusion criteria:

* patients affected by HCC with indication to TAE from a multidisciplinary team discussion.

Exclusion criteria

* TAE for other malignancies or bleedings;
* Pregnancy.
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.

This is an observational study of people with severe cystic fibrosis that are eligible for Vertex's triple combination therapy through its expanded access. Pulmonary health, intestinal health, and the overall health of individuals will be tracked for a year to see how effective triple combination therapy is in these people with severe cystic fibrosis disease.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Cystic Fibrosis
* Ability to reproducibly perform spirometry (according to ATS criteria)
* Physician decision to treat with TCT through the EAP program
* Ability to understand and sign a written informed consent or assent and comply with the requirements of the study

Exclusion Criteria:

* History of hypersensitivity to VX 445, VX 659, tezacaftor and/or ivacaftor
* Any acute lower respiratory symptoms treated with oral, inhaled or IV antibiotics or systemic corticosteroids within the 2 weeks prior to Visit 1.
* Major or traumatic surgery within 12 weeks prior to Visit 1.
* Initiation of any new chronic therapy (e.g., ibuprofen, Pulmozyme®, hypertonic saline, azithromycin, TOBI®, Cayston®) within 4 weeks prior to Visit 1.
* Use of an investigational agent within 28 days prior to Visit 1.
* History of lung or liver transplantation or listing for organ transplantation.