cyrilzakka/clinical-trials huggingface dataset:
The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)

The investigators are conducting a randomized clinical trial of rapid abstinence initiation and cognitive control training as a precursor to our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program to evaluate its effectiveness relative to standard outpatient counseling at the Midwestern Connecticut Council of Alcoholism (MCCA). CCT will be used to assess attention, working memory and inhibitory control and the computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving cocaine abuse treatment.

150 cocaine dependent individuals will be randomly assigned to one of 3 conditions delivered over 4 weeks in the context of intensive outpatient treatment. 1. Treatment as Usual (TAU), 2. rapid abstinence initiation (RAI) or 3. computerized cognitive control training with escalating reinforcement for improved performance on training tasks (CCT). All participants will then receive an 8 week trial of CBT4CBT in addition to TAU. Follow up evaluation thru 6 months posttreatment will assess durability and delayed emergence of treatment effects.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Meet current DSM-5 criteria for cocaine use disorder
* Are sufficiently stable for 12 weeks of outpatient treatment
* Are willing to provide locator information for follow-up
* Are fluent in English
* Have a 6th grade or higher reading level for completion of assessments

Exclusion Criteria:

* Untreated bipolar or schizophrenic disorder
* Current suicide risk
* Have a legal case pending such that incarceration during the 12-week protocol is likely
* Are physically dependent on alcohol, opioids or benzodiazepines and require detoxification
Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures

Multiple vertebral fragility fractures, one of the main complications of osteoporosis, are frequently associated with thoracic hyperkyphosis, which in turn leads to significant postural alterations.

These biomechanical changes may increase fall risk, posing a critical clinical issue for elderly patients. However, the results of studies investigating the association between hyperkyphosis and fall risk are conflicting, highlighting the need for further research.

This study aims to explore the correlation between the severity of thoracic kyphotic curvature and fall risk in patients with multiple fragility fractures undergoing osteoporosis treatment.

Additionally, the study seeks to evaluate the role of physiotherapy in improving patients' functional and postural outcomes.

A retrospective observational study was conducted, supplemented by a narrative literature review to contextualize the findings. Forty patients undergoing treatment at the Functional Recovery and Rehabilitation Unit (UOC) of P. Giaccone University Hospital in Palermo were enrolled and followed up via biannual phone interviews. Data were collected between May 2023 and May 2024, with a longitudinal assessment of outcomes from T0 (baseline) to T1 (12 months).

The severity of the kyphotic curve was quantified using the Cobb method, while fall risk was assessed through the Berg Balance Scale. Participation in physiotherapy programs was analyzed to evaluate their impact on clinical and functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥65 years.
* Presence of at least three documented vertebral fragility fractures.
* Diagnosis of thoracic hyperkyphosis

Exclusion Criteria:

* History of orthopedic surgeries involving the spine or lower limbs.
* Treatments for cerebrovascular diseases.
* Presence of balance disorders.
* Active oncological diseases.
* Use of walking aids
Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease

Hemorrhoidal disease is a frequent anorectal disorder and the main reason for a visit to a coloproctologist. Hemorrhoids are present in healthy individuals. However, they can become pathologic, manifesting with pain, prolapse, itching, bleeding or soiling. Initially, they can be managed conservatively. When this failed to cure the symptoms, surgical therapy is indicated. For grade II (hemorrhoids prolapsing during straining but reducing spontaneously) or grade III (hemorrhoids prolapsing during straining but requiring manual reduction), laser hemorrhoidoplasty or mucopexy are safe and efficient procedures to treat hemorrhoids. However, the optimal treatment is still under debate. Recently, a randomized controlled trial reported lower recurrence and faster return to work associated with laser therapy. We aimed to compare both therapies, to assess the benefits of laser therapy for the treatment of hemorrhoidal disease symptoms, using a validated score.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Hemorrhoidal disease grade II to III unresponsive to medical therapy
* Age ≥18

Exclusion Criteria:

* Inability to follow the procedures of the study,
* Enrollment of the investigator, his/her family members, employees and other dependent persons,
* Anesthesiology contraindications to surgery,
* Emergency situation,
* Hemorrhoids associated with pregnancy,
* Oher surgical intervention performed at the same time of the hemorrhoids treatment,
* Concomitant anorectal disorders (fissure, fistula), thrombosed hemorrhoid,
* Previous pelvic radiotherapy, previous proctologic intervention during the last three months.
Safety and Efficacy Study of EPI-743 in Children With Leigh Syndrome

The purpose of this study is to evaluate the effects of EPI-743 in children with Leigh syndrome on disease severity, neuromuscular function, respiratory function, disease morbidity and mortality and disease associated biomarkers.

The purpose of this study is to evaluate the effects of EPI-743 in patient with Leigh syndrome on disease severity, neuromuscular function, respiratory function, disease morbidity and mortality and biomarkers associated with the disease.

This study is a six month prospective randomized double-blind, placebo-controlled trial with a six month extension phase of two dose levels of EPI743. The planned enrollment is for approximately 30 children with genetically confirmed Leigh syndrome. After 6 months of treatment, those children that were randomized to the placebo treatment arm will be re-randomized to one of the 2 active treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and MRI diagnosis of Leigh syndrome
* Moderate disease severity based on NPMDS score
* Age under 18 years
* Documented evidence of disease progression within 12 month of enrollment
* Availability of MRI that confirms necrotizing encephalopathy
* Patient or guardian able to consent and comply with protocol requirements
* Abstention from Coenzyme Q10, Vitamins C \& E, lipoic acid and Idebenone

Exclusion Criteria:

* Allergy to EPI-743, Vitamin E or sesame oil
* History of bleeding abnormalities or abnormal PT/PTT
* Diagnosis of concurrent inborn error of metabolism
* Previous tracheostomy
* Ventilator dependent or use of noninvasive ventilatory support w/in 1 month of enrollment
* LFTs greater than 2 times ULN
* Renal insufficiency
* End stage cardiac failure
* Fat malabsorption syndrome
* Use of anticoagulant medications
* Abstention from Botox for 6 months prior to enrollment and for duration of study
Pilot Study on the Tolerability of Dietary Dried Plum

Dried plums (Prunus domestica L.) have traditionally been recognized for their health benefits related to conditions such as constipation, irregular menstrual cycles and mouth sores. This dried fruit provides high levels of fiber, vitamins and minerals. Dried plum has also been shown in animal studies to have beneficial effects on bone and can prevent the loss of bone caused by low hormone levels such as occurs after surgical removal of the ovaries. We also have shown that dried plum can prevent the loss of bone associated with aging in mice. Very few therapies for osteoporosis actually reverse bone loss and improve bone strength. The potential therapeutic value of dried plum in men and women with hormone deficiency or age-related osteoporosis is clear.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50 yrs and 75 yrs
* Nonsmokers
* Normal renal and hepatic function

Exclusion Criteria:

* Subjects who must follow a specific diet
* Subjects on any daily medications that affect bone health
* Subjects too heavy for the DEXA machine (weight limit 300 lbs)
* Subjects whose BMD by DEXA indicates osteoporosis
* Subjects unwilling to follow the diet specified
* Pregnant women
* Subjects who are unable to understand the consent form.
Effect of Atorvastatin Versus Rosuvastatin Intensive Statin Regimens on Chinese Elderly Patients Undergoing PCI

This randomized, open label, parallel-group study is designed to investigate whether periprocedural intensive statin therapy with atorvastatin versus rosuvastatin administration before PCI and 30-day continuous intensive treatment is superior to usual care, in terms of cardiovascular events for Chinese elderly patients.

1800 elderly patients (\>65 yr) with coronary artery disease undergoing elective PCI were randomized in 2:1 fashion into either intensive statin group or standard care group. Patients in intensive statin group is further randomized into two subgroups: administrated with either atorvastatin 80mg 12h prior PCI, then 40mg 2h prior PCI, followed by 40 mg/d for 30 days after PCI; or rosuvastatin 20mg 12h prior PCI, then 10mg 2h prior PCI; followed by 10 mg/d for 30 days after PCI, while the standard care group receives atorvastatin 20 mg/d. After angiography, patients who are not undergoing PCI procedure will be excluded from the study as selection failure. The last visit will be at 6 months after PCI. Clinical data such as troponin, CK-MB, Scr, CCR, ALT, AST before and 24h to 48h after procedure will be recorded. 1000 eligible patients will be finally enrolled.The study will be conducted at 12 centers in China.

Eligibility Criteria:
Inclusion Criteria:

65-80 years old Patients undergoing for elective percutaneous coronary intervention Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

* Patients undergoing emergency percutaneous coronary intervention
* Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pruvastatin 40mg/d, fluvastatin 80mg/d or rovastatin 5mg/d ) in the next 6 months, or needing to take fibrates or niacins simultaneously according to investigators' judgment.
* LDL-C \< 1.8mmol/L in patients without statin therapy
* Endstage congestive heart failure, or LVEF \< 30%
* Active hepatic disease or hepatic dysfunction, or AST/ALT \> 1.5UNL
* Myopathy or increased creatine kinase (CK\>2 UNL)
* WBC \< 4×109/L or PLT \< 100×109/L
* Severe renal dysfunction(Scr \> 3 mg/dl or 264μmol/L)
* Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
* Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
* Accompanied with malignant disease or other disease, which cause life expectancy \< 6 months
* Participating in other interventional clinical trials using drugs or devices
* Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
Atrial Natriuretic Peptide in Assessing Fluid Status

Biomarkers can play a significant role in fluid status assessment intraoperatively.

Routinely intraoperatively the fluid status assessment is based on central venous pressure and other parameters. Nevertheless, the minority of anesthesiologists use continous dynamic parameters like pulse pressure variation, stroke volume variation and other to manage fluid status. There's a fast acting biomarker that can help anesthesiologist to diagnose and manage the volemic status and possibly guide the infusion therapy better.

Pro-ANP is a biomarker that reacts on atria strain and can be used in volemic status assessment in cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria:

CABG, one-, two valve repair/replacement, ascending aorta, aortic arch replacement, ASD/AVD closure, septal myectomy

Exclusion Criteria:

1. Atrial fibrillation, atrial flutter, frequent ventricular and supraventricular arrythmias
2. EFLV \< 50%
3. Pulmonary hypertension \> 2 st
4. CKD \> C3 (GFR \< 30)
5. Redo surgery
6. Left atrium volume \> 150 ml
7. LV EDV \> 250 ml
Safety of Spine Radiofrequency Procedures

The goal of the study was to determine if patients undergoing radiofrequency neurotomy (RFN) of lumbar facet joints that are adjacent to previously placed pedicle screws from a fusion, would lead to an increase in the temperature of the pedicle screws.

This study was a prospective clinical trial, examining outcomes related to temperature increases in pedicle screws. It was not possible to blind the investigators or the patient. Outcomes related temperature differences were collected at each pedicle screw adjacent to a zygapophyseal joint being treated.

A conventional 18-gauge, 1-cm curved active tip radiofrequency cannula was placed under fluoroscopic guidance to the area to be treated (the junction of the transverse process and the superior articulating process of the facet joint). This position placed the tip of the radiofrequency cannula immediately adjacent to, but not in direct contact with, the pedicle screws. The radiofrequency cannula was connected to a radiofrequency generator, and the conventional settings for clinical medial branch neurotomy was used, heating the tissue to 80°C for 90 seconds. The procedure described up to this point is the normal procedure and protocol for RFN performed at the Mayo Clinic.

The experimental portion of the procedure is as follows: A separate 22 gauge radiofrequency cannula was intentionally placed in direct contact with the dorsal surface of the pedicle screws and was connected to a radiofrequency generator solely for the purpose of measuring temperature, as the RF cannula are dual purpose probes capable of both conducting energy for the radiofrequency lesion and monitoring tissue temperature. In other words, this small gauge needle was placed for the sole purpose of acting as a thermistor probe/temperature monitor. This process was repeated for each level necessary for treatment.

Eligibility Criteria:
Inclusion Criteria:

- Scheduled for Radiofrequency procedure AND has spinal hardware placed from a previous spinal surgery

Exclusion Criteria:

* Active infection over skin where needle will be placed
* Coagulopathy
* Pregnancy
Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects

The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal.

Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>30 kg/m2 \& \<45 kg/m2

Exclusion Criteria:

* Diabetes
* lipid lowering drugs
* Liver-, Kidney- and/or Heart Disease
* Serious Hypertension (160/110)
Ultrasound Detection of Peripheral IV Infiltration

The purpose of this study is to determine whether commercial ultrasound imaging systems can discern normal from infiltrated tissue near a peripheral intravenous site.

Peripheral intravenous (PIV) therapy is one of the most common invasive procedures performed in US hospitals. A majority of hospital patients require intravenous therapy each year in the United States. Despite widespread use, a number of potential complications can occur during PIV therapy. One of the most common causes of IV complications is IV infiltration or extravasation. Infiltration is the leakage of non-vesicant fluids like saline into the surrounding tissue. Extravasation is the leakage of vesicant fluids, which include cytotoxic drugs, intravenous nutrition, and calcium, potassium, and bicarbonate solutions. If not detected and corrected early, infiltration and extravasation can lead to significant complications such as severe inflammation, compartment syndrome, and skin necrosis.

ivWatch, LLC has developed an investigational device that may detect IV infiltration and extravasation occurrences using a near infrared light sensor. Previous studies have evaluated the performance of the ivWatch device by comparing to a nurse's diagnosis. The nursing standard of care relies on tactile and visual indicators to diagnose an infiltration event. The ivWatch product often signals an infiltration event before these indicators are apparent to clinicians. Consequently, comparisons to the nurse's diagnosis often lead to questionable false positives for the ivWatch device. A better reference is required to evaluate the performance of the ivWatch device.

The purpose of this research study is to evaluate the ability of ultrasound to detect PIV infiltrations. Ultrasound is a depth-resolved imaging technique for evaluating tissue microstructure. Researchers have used ultrasound to examine exogenous fluids injected into cutaneous and subcutaneous tissue. Ultrasound has been used to detect small volumes of fluids such as cosmetic fillers and subcutaneous injections. These studies suggest ultrasound may be a potential reference standard for future evaluation of ivWatch devices.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* signed consent
* health form approved by professional practitioner

Exclusion Criteria:

* abnormal bleeding or hemophilia
* absence of sensation in arms
* anemia
* cardiopulmonary disorders
* clotting disorders
* dehydration
* dizziness or fainting
* hepatitis
* high blood pressure (\>160 systolic or \> 115 diastolic)
* HIV / AIDS
* immune deficiency disorders
* known history of difficult venous access
* lymphedema
* major surgery or scar tissue which would complicate venous access
* recent radiation or chemotherapy
* received IV therapy in past 30 days
* history of seizures
* history of strokes
* sick or had infection in past 30 days
* high temperature (\>99.6F)
Efficacy of Exercise Methods in Postmenopausal Women: a Clinical Trial

This study aims to evaluate the effectiveness of different exercise methods in improving health outcomes for postmenopausal women. As women go through menopause, they may experience changes such as decreased bone density, muscle weakness, and an increased risk of chronic diseases. Exercise is known to be beneficial in reducing these risks, but the best approach remains unclear.

In this clinical trial, participants will engage in structured exercise programs designed to improve bone health, strength, and overall well-being. The study will compare different types of exercises to determine which method provides the most benefits. By participating in this research, postmenopausal women can contribute to a better understanding of how exercise can enhance health during this stage of life.

This study is safe, and all exercises are guided by professionals. The results will help healthcare providers recommend the most effective exercise strategies for postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Being between 40-65 years of age Having a Body Mass Index (BMI) below 40 Scoring 68 or above on the System Usability Scale Having no orthopedic problems Completing the informed consent form Being within 5 years after a 12-month amenorrhea history

Exclusion Criteria:

* Presence of visual impairments Presence of musculoskeletal system disorders Presence of cognitive impairments Presence of joint range of motion limitations Presence of severe cardiac problems Participation in another program
Consequences of Respiratory Devices on Caregivers (CAP2)

The promoter of the study will conduct a monocentric cohort study that aim to evaluate the consequences of home respiratory devices on patient caregivers' quality of life.

The investigators will examine the impact of home respiratory devices on quality of life in general, sleep quality, anxiety and humour depending on equipment type (Non-invasive ventilation (NIV), continuous positive airway pressure (CPAP) or long-term oxygen therapy (LTOT)) for patients and partners. The investigators will assess the correlation between patient and caregiver's answers. The investigators will assess the correlation between couple's quality of life and adherence to treatment.

To do this, the investigators will use four quality of life questionnaires and the investigators will collect demographic data, medical data and usage report from the equipment.

Home respiratory devices improve patients' quality of life and clinical outcomes. However, they bring medical equipment into the bedroom and are used overnight. The aim of this prospective cohort is to assess the quality of life of patient's caregivers.

Patient caregivers' quality of life will be assessed using the WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire).

The investigators expect to enroll 200 patients' partners equipped with non-invasive ventilation, 100 patients' partners equipped with continuous positive airway pressure and 50 patients' partners equipped with long-term oxygen therapy. Patients will be recruited from the cohort of patients already established on home treatment and cared for by Asten Santé.

After consent, patient will receive dedicated questionnaires. During a home visit, home healthcare provider technician will retrieve data from the home device.

Eligibility Criteria:
Inclusion Criteria:

For the patient :

* Patient with a diagnostic of chronic obstructive pulmonary disease (COPD), sleep apnea or obesity hypoventilation syndrome
* Home respiratory equipment (NIV, CPAP or LTOT) since more than 3 months, patient and partner who shared the same household
* patient with medical stable condition
* patient who consents
* patient older than 18 years old
* patient followed at Rouen University Hospital

For the partner :

* patient who consents
* patient older than 18 years old

Exclusion Criteria:

For the patient :

* Home respiratory equipment for neuromuscular disease
* Patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship)
* patient not able to consent

For the partner :

* Patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship)
* patient not able to consent