cyrilzakka/clinical-trials huggingface dataset:
Self-compassion and Bipolar Disorder

Currently, pharmacotherapy is central in the management of bipolar disorder (BD), but does not guarantee satisfactory results for many patients. Existing psychotherapies, notably cognitive-behavioral therapy (CBT), show some effectiveness, but do not target the mechanisms that maintain the disorder. Indeed, people with BD present a low level of self-compassion, suffer from comorbidities (e.g. anxiety, depression), and have a high level of emotional dysregulation, which can contribute to increasing the risk of relapse and mood instability.

In this context, it has been suggested that interventions targeting self-compassion could reduce BD psychopathology and strengthen emotional regulation skills.

Two psychological therapies targeting self-compassion could be promising in the treatment of BD: Compassion-Based Therapy (CBT) and Cognitive Therapy focused on Mental Imagery (mTCI). These approaches partly emphasize compassionate mental imagery to promote self-soothing and emotion management skills.

Studies on the feasibility and effectiveness of CBT and mTCI in the context of BD are few in number, and do not focus on their impact on emotional regulation abilities. Evaluating these therapies could lead to the development of more specific and effective interventions for people with TB.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥ 18 years old)
* Subject with diagnosed bipolar disorder followed on an outpatient basis, in a day hospital or outside the hospital during the period from January 1, 2022 to February 29, 2024.
* Absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed his opposition to the reuse of his data for scientific research purposes.
* Judicial measures: care under constraint or patient deprived of liberty due to a legal measure
Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation

In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.

While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (\< 3 mm) which occurs on average in \~40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology.

Eligibility Criteria:
Inclusion Criteria:

* Female, 18-100 years old
* Not pregnant or breastfeeding
* Pre-study radiologic documentation of:
* size ≤ 5 cm
* unicentric, unilateral
* suspicious mass or calcification
* BIRADS classification ≥ IV
* location of abnormality \> 1 cm from skin
* Ductal or Infiltrating Ductal Carcinoma
* Grade I-III on final pathology
* Good general health
* Zubrod Performance Status of 0,1, or 2
* No previous chemotherapy
* No palpable axillary or supraclavicular lymph nodes
* If prior non-breast malignancy, must have \> 5 year disease-free survival

Exclusion Criteria:

* Patient \< 18 y/o or \> 100 y/o
* Pregnant or breastfeeding
* Male
* Breast implants
* Multicentric disease or bilateral disease
* Lesions \> 5 cm in diameter
* Lesions \< 1.0 cm from the skin
* Previous prior radiation to the breast
* Need for mastectomy
* Diffuse microcalcifications (as determined by the Investigator)
Effect of Spinae Erector Block (ESP) and Gabapentin on Recovery and Length of Stay in Adolescent Spinal Fusion Patients

A retrospective cohort study comparing time to ambulation (hours) between two groups of adolescent spinal fusion patients: a group who received intravenous multimodal analgesic strategy alone (MMA group) and another group who received a multimodal analgesic strategy in combination with a preoperative ESP block and oral gabapentin (MMA-ESP-G group).

One of the major challenges in postoperative care following posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS) is achieving adequate pain control. Opioid-sparing multimodal anesthetic strategies are crucial for achieving effective postoperative pain control and facilitating early mobilization. The erector spinae (ESP) block has been reported as part of various opioid-sparing strategies for spine surgery. Perioperative oral gabapentin (in different dosing protocols) may contribute to reduce postoperative pain and opioid consumption.

The primary aim of this retrospective study was to compare time to ambulation (hours) between two groups of adolescent spinal fusion patients: a group who received intravenous multimodal analgesic strategy alone (MMA group) and another group who received a multimodal analgesic strategy in combination with a preoperative ESP block and oral gabapentin (MMA-ESP-G group). The secondary aim was to compare intensive care length of stay, perioperative opioid requirements and time to urinary catheter removal between groups.

This is a retrospective review of 34 consecutive adolescent spinal fusion patients during August-September 2023 at Hospital Italiano de Buenos Aires, Argentina. The investigators compared two groups: 1) MMA group received an intravenous multimodal analgesic strategy, 2) MMA-ESP-G group received an intravenous multimodal analgesic strategy in combination with a preoperative, ultrasound-guided, bilateral ESP block (administration of a local anesthetic mixture of ropivacaine 0.375% and lidocaine 1%) and a 100mg dose of oral gabapentin 4 nights daily before surgery and 2 weeks postoperatively. Both strategies were protocolized at our institution.

Data was analyzed for the primary outcome: median time to ambulation difference between groups. Differences were considered statistically significant at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of adolescent idiopathic scoliosis (AIS) and primary surgical indication between January 2018 and August 2023.
* ASA patients (American Society of Anesthesiology classification) I to III.

Exclusion criteria:

* Patients who, at the end of the procedure, were transferred to the PICU (Pediatric Intensive Care Unit) on mechanical ventilation.
* Patients undergoing corrective scoliosis surgery in combination with any other surgical procedure.
* Patients who received ESP block postoperatively (Group EM-ESP-G).
Single Ascending Dose Safety Study of Oxfendazole

This research is being done to learn about the safety in humans of a medicine that is already used in cows and pigs to treat worms. The medicine may be useful for people who have these or other worms. The medicine will be studied first in healthy people, who will be given a very small amount of the medicine once. If the smallest amount of medicine is found to be safe, a slightly higher amount will be given to a new group of volunteers. The highest amount that will be tested is similar to the amount given to animals. If the medicine can be given safely to healthy people in the planned amounts, a later study will be done in people who have worms to see if the medicine kills the worms.

The Phase I study proposed is a randomized, double-blind, placebo-controlled evaluation of the safety and pharmacokinetics of escalating single oral doses of oxfendazole (0.3 to 30 mg/kg) in healthy volunteers. The dose will be increased approximately three-fold (one-half log) at each increment, and each cohort will comprise ten volunteers (eight drug, two placebo). Subjects will be monitored for three weeks after dosing, including monitoring the pharmacokinetics and metabolism of oxfendazole in blood and urine. Each new cohort will be dosed only after the three week safety data for the preceding group have been analyzed. If a clinically significant adverse event is observed, and if this event is possibly drug-related, an additional (and final) cohort of volunteers will repeat the highest tolerated dose of oxfendazole. Up to 70 volunteers (56 drug, 14 placebo) will complete the study.

Eligibility Criteria:
Inclusion Criteria:

* Height and weight within 25% of means for his/her gender and age.
* Willing to use two acceptable methods of contraception (approved oral, injectable, or implantable drug, IUD, diaphragm or condom with spermicidal jelly or foam, or sexual abstinence) for a minimum of one week before, and three weeks after dosing with oxfendazole; or surgically sterile.
* Able to give written informed consent.
* Able to provide a home phone number, and the name, address, and phone number of a person willing to assist making contact during the follow-up phase of the study.

Exclusion Criteria:

* Pregnant.
* Breast feeding.
* Chronic drug/alcohol user.
* Has clinically significant abnormalities in screening examinations
* Has history of sensitivity to related benzimidazole compounds (e.g. albendazole, mebendazole).
Effect of Viscous Soluble Fibers on Serum Cholesterol Levels

Research over the past several decades have linked the intake of dietary fiber with lower blood cholesterol levels. The distinction between soluble and insoluble fiber fractions emerged shortly after and there is now a general consensus that soluble fiber possesses the capacity to lower cholesterol. Since the discovery of the cholesterol lowering effects of soluble dietary fiber, there has been much debate as to the degree of cholesterol reduction from these fibers. In order to handle the inconsistencies a full and systematic review of the published literature was conducted by Brown et. al (1999). Results from this meta-analysis, concluded that 'increasing soluble fiber can make only a small contribution to lowering cholesterol.'

Research is constantly progressing and new research findings may not always be consistent with older data. For example, results from new research are now challenging the previously approved health claims for soy foods and fatty acids. This is a major public health concern because if clinical evidence is not reliable, it could lead to harm. Since the publication of the meta-analysis by Brown et. al (1999) over a decade ago, scientists have continued to research the effects of soluble fiber on cholesterol levels with new technology and trial designs, therefore it is crucial to revisit the question and update the literature on the effect of viscous soluble dietary fibers on serum cholesterol levels.

A series of meta-analyses will be performed to assess the link between viscous dietary fibers and serum cholesterol levels. Nutritionists now consider fiber to be an integral part of diet and disease. Results from these meta-analyses help address the question of whether viscous soluble fibers have a role lowering serum cholesterol levels.


Eligibility Criteria:
Inclusion Criteria:

* Randomized Controlled Trials
* Paralell or Crossover Design
* Duration: \>3 weeks
Hemodynamic Monitoring During Abdominal Aortic Surgery

This trial investigates the ability of our istitutional algorithm in maintaining a safe hemodynamics during abdominal aorta open surgery, in terms of limitation of intraoperative hypotension incidence

The present trial includes patients submitted to abdominal aorta open surgery. This type of procedure is very challenging for the hemodynamic management because of the operation per se (during which the surgeon clamp and unclamp the aorta with very significant hemodynamic variations) and because of the altered tone of the vessels due to the general vascular disease such a type of patients is suffering from.

The aim of this study is to verify if the incidence of intraoperative hypotension in terms of severity, lasting and number of episodes, may be reduced by the application of a protocol of hemodynamic management.

Primary endpoint: Global time spent in hypotension \<10%.

Secondary Endpoints:

1. Time Weighted Average (TWA) of Area Under the Threshold \<0.4 mmHg
2. Incidence of hypotensive events/patient \< 8 (including the expected hypotensive events due to the aortic clamping and unclamping)

Eligibility Criteria:
Inclusion Criteria:

* Adults patients undergoing abdominal aorta open surgical repair

Exclusion Criteria:

* Emergent/urgent operation
* Age \<18 years
* Pregnancy
* Intra-operative blood loss \> or = 3000ml
A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028)

Levothyroxine (T4) is a man-made thyroid hormone used to treat certain thyroid conditions. After taking levothyroxine, a person's body changes it to triiodothyronine (T3). The amount of levothyroxine in a person's blood must be carefully controlled to maintain proper function. Enlicitide decanoate was designed to lower the amount of cholesterol in a person's blood.

Researchers want to learn about levothyroxine when taken at the same time with enlicitide decanoate. They want to:

* Measure a person's blood to find out if the amount of levothyroxine in the blood is the same when levothyroxine is taken alone or with enlicitide decanoate
* Learn about the safety of levothyroxine when taken alone or with enlicitide decanoate and if people tolerate it


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Medically healthy with no clinically significant medical history
* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* History of cardiovascular disease or diabetes mellitus
* History of cancer
Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers

This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non pregnant, non lactating healthy females age 18-50 years;
* Must be able to produce acceptable sputum sample by induction;
* Must respond to ozone inhalation with a \> 10% increase in the absolute percentage of sputum neutrophils and the total neutrophils (neutrophils/gram sputum) must increase by at least 50% from the sputum neutrophil count at screening;
* Volunteer is a non-smoker or ex-smoker of at least 12 months' duration prior to screening with a history of less than 1 pack per year.

Exclusion Criteria:

* Volunteers receiving chronic medication other than oral contraceptives;
* Screening forced expiratory volume FEV1 is \< 80% of the predicted value for their age, gender, height and race and/or their FEV1/FVC ration is below 70%;
* Volunteers with significant occupational exposure to respiratory irritants or toxins
* Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 3 months;
* Volunteers taking any medication that may affect the respiratory tract within 30 days of the first study day;
* Volunteers with a history of asthma
BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)

It is well known that sleep is essential for brain development and learning. Infants require extensive sleep for development of the hippocampus, pons, brainstem, and midbrain and for optimizing physical growth. It is also essential for brain plasticity; the genetically determined ability of the infant brain to change its structure and function in response to the environment. Studies in young animals have shown that sleep deprivation leads to increased programmed cell death, smaller brain size, and loss of brain plasticity, all of which have negative long-term impact on behaviour and learning ability.

Infant massage, a form of systematic tactile stimulation by human hands, improves sleep hygiene. Very little is known about how massage influences early brain development but it is certainly linked to the theory of environmental enrichment, which has been well established in animal models.

The aim of this project is to optimise the infant's sensory experience through a multi-sensory enrichment programme, including massage (a massage utilising a scented lotion before sleep each day), to encourage more structured sleep and ultimately show improved developmental and cognitive outcomes.

See study protocol attached.

Eligibility Criteria:
Inclusion Criteria:

1. Infants born \> 37 weeks gestation
2. Single births
3. Not requiring admission to the Neonatal Unit
4. Healthy infants without suspected congenital or metabolic anomalies

Exclusion Criteria:

1. Infants born \< 37 weeks gestation
2. Multiple births
3. Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.
PerAF: AF Termination vs Prespecified Ablation

The design of this study is an intervention, randomized, controlled study and contains two randomized groups：（1）AF-termination group；（2）Prespecified-ablation group.


Eligibility Criteria:
Inclusion Criteria:

1. aged between 18 and 80 years old;
2. Patients undergoing a first-time ablation procedure for PersAF, and in spontaneous AF at the beginning of the procedure;
3. Diagnosed as persistent AF according to the latest clinical guidelines，with atrial fibrillation lasting for at least one month;
4. Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment;
5. Patients must be able and willing to provide written informed consent to participate in this study;
6. Patients must be willing and able to comply with all study follow- up requirements.

Exclusion Criteria:

1. .Uncontrolled congestive heart failure, EF \<35%;
2. . History of severe valve disease and/or prosthetic valve replacement;
3. . Myocardial infarction or stroke within 6 months;
4. . Severe congenital heart disease;
5. . Left atrial diameter ≥60mm;
6. . Contrast agent allergy;
7. . The use of anticoagulant drugs is contraindicated;
8. . Severe lung disease;
9. . Left atrial thrombus confirmed by preoperative esophageal ultrasound;
10. .Contraindications for cardiac catheterization;
11. .Prior left atrial ablation (surgical or catheter);
12. .Have performed any cardiac surgery within 2 months;
13. .Poor general health;
14. .Life expectancy \< 12 months, including factors such as physical inability to tolerate ablation or unstable disease conditions.-
Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version

External Cephalic Version (ECV) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. Its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. ECV is an effective technique to reduce the rate of cesarean sections and is recommended by the Spanish Society of Obstetrics and Gynecology (SEGO) and the World Health Organization (WHO) Cesarean Section Working Group. The WHO aims to reduce interventionism in childbirth globally and implement non-clinical measures to reduce the rate of unnecessary cesarean sections.

Despite Propofol is a sedative agent commonly used by anesthesiologist in countless ambulatory procedures in obstetric anaesthesia, it has been little studied in ECV, and its effect has not been compared with other commonly used agents such as remifentanil or spinal analgesia. The Obstetric Anesthesiology Section of the Spanish Society of Anesthesiology and Resuscitation recommends the use of locoregional analgesia in ECV.

This project involves a randomized clinical trial to compare the effect of sedation with propofol versus spinal analgesia in ECV. Therefore, the objectives of this study are:

* To compare the effect of sedation with Propofol on the success rate of ECV compared to spinal analgesia.
* To compare the effect of sedation with Propofol on the rate of complications of ECV compared to spinal analgesia.
* To compare the effect of sedation with Propofol on the length of hospital stay of ECV compared to spinal analgesia.

Locoregional analgesia requires a longer hospital stay than sedation with Propofol and may mask an early diagnosis of complications after ECV, such as placental abruption, which is identified in the initial stages by intense abdominal pain.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation.
* Older than 18 years.
* Non-cephalic presentation.
* Desire to attempt a vaginal birth.
* Normal blood count and coagulation prior to the intervention

Exclusion Criteria:

* Age under 18 years old.
* Multiple gestation.
* Cephalic presentation.
* Risk of fetal compromise.
* Unexplained active bleeding.
* Absolute contraindication for vaginal delivery (Placenta Previa)
* 2 or more previous cesarean sections.
* Previous myomectomy with entry into the uterine cavity
* Maternal fever.
* Thrombocytopenia (\<85,000 platelets).
* Maternal spinal anomaly.
* Intolerance or allergy to Propofol or any of its components.
* Intolerance or allergy to bupivacaine or any of its components.
* Contraindication for intrathecal sedation or analgesia
Definition of ARDS in Qinghai Province: Verification of Berlin Definition Plateau Criteria

The severity stratification criteria for acute respiratory distress syndrome (ARDS) in Xi'ning Qinghai province (mean altitude: 2200m) were clarified according to the oxygenation index (PaO2/FiO2).

This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, affiliated Hospital of Qinghai University from January 2018 to December 2018 were divided into three groups: mild (153mmHg \< PaO2/ FiO2 ≥ 230 mmHg), moderate (76mmHg \< PaO2/ FiO2 ≥ 153 mmHg) and severe (PaO2/ FiO2 ≥ 76 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time and non-I hospitalization were observed respectively. The difference of CU time and total hospitalization days.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Meet the diagnostic criteria of ARDS
* Receive invasive mechanical ventilation

Exclusion Criteria:

* Receive a large number of hormone shock therapy in a short period of time
* Death within a short period of time (\< 24 h) after mechanical ventilation
* No chest imaging data
* Data missing