cyrilzakka/clinical-trials huggingface dataset:
Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services

The aim of this study is to assess and compare the benefits of twopsychological interventions added to the usual treatment of patients whocome to mental health. Patients will be randomly assigned to the followingconditions: Mindfulness-Based Stress Reduction (MBSR), Attachment-BasedCompassion Therapy (ABCT) and a Treatment As Usual (TAU) Group. Theparticipants in the two psychological intervention groups will also receive usualpsychological/psychiatric treatment managed by their specialist. Mindfulnessand Compassion groups will be composed of 33 participants each, and TAU group will be composed of 64 participants (total sample n = 130).

The principal hypothesis is that 'ABCT + TAU' will be more effective than'MBSR + TAU' for treating depressive and/or anxiety symptoms in patients attending mental health settings. Secondary hypothesis are: 1) 'MBSR + TAU'and 'ABCT + TAU' will be more effective than 'TAU alone' for treatinganxiety and/or depressive symptoms in patients attending mental health settings; 2) mindfulness will be a mediator of the 'MBSR + TAU' program improvements, while self-compassion will be a mediator of the corresponding'ABCT + TAU'; and 3) 'ABCT + TAU' will present more cost-effectiveness than 'MBSR + TAU' and both ABCT + TAU' and 'MBSR + TAU' programs will present more cost-effectiveness than TAU alone.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years old.
* Depressive and/or anxious disorder, or adjustment disorder with depressive or/and anxious symptomatology, according to clinical criteria based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
* Disorder of mild or moderate severity according to clinical criteria (based on DSM-5).
* Understand perfectly spoken and written Spanish.
* Grant a written informed consent form

Exclusion Criteria:

* To have done any type of meditative/contemplative practice during the previous year.
* Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.).
* Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.).
* Any medical, infectious or degenerative disease that may affect mood.
* Presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk.
World Health Organization Disability Assessment Schedule II (WHODAS-II) for Patients With Symptomatic Lumbar Spinal Stenosis

The main purpose of this study is to determine the measurement characteristics of WHODAS-II (World Health Organization Disability Assessment Schedule II), as well as to analyze its correlation with symptomatic lumbar spinal stenosis (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ), and quality of life (SF-12). Measurements will be taken at baseline and 6 days later (day 7).


Eligibility Criteria:
Inclusion Criteria:

* Patients seen for symptomatic lumbar spinal stenosis
* With signs of neurogenous claudication
* MRI or CAT scan concordant with observed signs
* Able to read and write
* Have signed the informed consent form

Exclusion Criteria:

* Central nervous system pathology (with or without treatment)
* Diagnosis of rheumatic inflammatory disease or fibromyalgia
* Red flags for underlying systemic disease
* Criteria for diagnosis of disc herniation
* Symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis
* Motor deficit that progresses or does not improve in 6 weeks
Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders

This is a multicenter, randomised controlled trial. The investigators plan to randomise 836 participants to the immediate FET or the postponed FET from the day of oocyte retrieval to the last day of that menstrual cycle in a 1:1 rate. Primary outcome will be the live birth rate after the embryo transfer.

It is postulated that postponing embryo transfer for at least one menstrual cycle after a freeze-all cycle can minimise the possible residual negative effect caused by ovarian stimulation and can promote the resumption of a normal ovulatory cycle and the receptivity of endometrium. Nevertheless, emerging evidence suggests a higher live birth rate in the immediate freeze-all embryo transfer (FET) cycles compared to that in the delayed group. It is unclear the whether postponed FET is superior in hyperresponders. The investigators hypothesize the success rate in the postponed FET for at least one menstrual cycle after oocyte retrieval is higher than in the immediate FET in hyperresponders.

Objective: To evaluate whether the postponed FET for at least one menstrual cycle after oocyte retrieval is superior to the immediate FET in the first menstrual cycle after oocyte retrieval in hyperresponders in terms of live birth rates.

Design: a multicenter, randomised controlled trial Patients: The investigators plan to randomise participants to the immediate FET and the postponed FET from the day of oocyte retrieval to the last day of that menstrual cycle.

Primary outcome: live birth rate after the embryo transfer. Patients who get pregnant will be followed up until 6 weeks after delivery.

Sample size: The investigators plan to enroll 836 participants in a 1:1 rate.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 20 to 42 years old;
* Written informed consent;
* Women scheduled for freeze-all embryo transfer;
* Women with the number of oocyte collected higher than 15.

Exclusion Criteria:

* Women with a history of at lease three failed transfer cycles;
* Women with an endometrial thickness less than 7 mm on the triggering day;
* Severe uterine malformations.
Three Dimensional Virtual Reconstruction (3D) in Percutaneous Nephrolithotomy

The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training.


Eligibility Criteria:
Inclusion Criteria:

* Patients with kidney stones larger than 2 cm and those with PCNL indication.

Exclusion Criteria:

* Patients with missing CT images, missing clinical information, or inaccessible
Complications of Non-Surgical Treatment in Acute Cholecystitis

Acute cholecystitis (AC) is the second most frequent pathology in Surgical Emergencies; laparoscopic cholecystectomy (LC) is the gold standard treatment, but not all patients are fit for surgery. Percutaneous Cholecystostomy (PC) is an alternative to LC but has high comorbidity. There is no protocol in our institution for Non-Surgical Treatment (NST). This study aims to analyse the complications of non-surgical treatment and a new local management algorithm

It's a single-centre retrospective study of 1652 adults with AC from 2011 to 2022, including baseline demographic characteristics, comorbidity severity defined as the Charlson Comorbidity Index (CCI), ASA Score, and Tokyo Guidelines' severity classification. The primary outcome is to study the complications of NST.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic of an Acute Cholecystitis.
* Older than 18 years old.

Exclusion Criteria:

* Younger than 18 years old.
PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS

This is an open label, single arm study in healthy Chinese male and/or female adult participants. Approximately 9 participants total are planned to participate in this study to ensure that a total of 8 evaluable participants (with all primary PK parameters) can complete the study.


Eligibility Criteria:
Inclusion Criteria:

* Only females of non-childbearing potential
* Male and female Chinese participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12 lead ECG.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Body mass index (BMI) of 19 to 27 kg/m2; and a total body weight \>50 kg.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg. Gastrectomy, cholecystectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or syphilis; positive testing for HIV, hepatitis B, hepatitis C, and serological reaction of syphilis. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm.
* Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
* Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.
* History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
* Previous administration of an investigational drug within 90 days or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).
A Comparison of Seated Thoracic Manipulation and Targeted Supine Thoracic Manipulation on Cervical Flexion Motion and Pain

Thirty-nine patients with cervical spine pain were randomly assigned to either a seated thoracic manipulation or targeted supine thoracic manipulation group. Pain and flexion range of motion measures were taken before and after the intervention.

DESIGN: Randomized clinical trial OBJECTIVES: To determine the effectiveness of seated thoracic manipulation versus targeted supine thoracic manipulation on cervical spine pain and flexion range of motion. There is evidence that thoracic spine manipulation is an effective treatment for patients with cervical spine pain. This evidence includes a variety of techniques to manipulate the thoracic spine. While each of them is effective, no research has compared techniques to determine which produces the best outcomes.

METHODS: Thirty-nine patients with cervical spine pain were randomly assigned to either a seated thoracic manipulation or targeted supine thoracic manipulation group. Pain and flexion range of motion measures were taken before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria required patients to be between 18-60 years old with a primary complaint of neck pain

Exclusion Criteria:

* identification of red flags suggestive of nonmusculoskeletal etiology, history of whiplash injury within six weeks of the initial visit, diagnosis of cervical spine stenosis, central nervous system involvement, or signs of nerve root compression (two of the following limited at the same level: strength, sensation, reflexes).
Machine Learning Enabled Time Series Analysis in Medicine

The goal of this observational cohort study is to investigate the potential of fitness trackers in combination with machine learning algorithms to identify cardiovascular disease specific patterns.

Two hundred participants will be enrolled:

1. 50 with heart failure
2. 50 with atrial fibrillation
3. 100 (healthy) individuals without the former two conditions

All participants are given a Fitbit device and monitored for three months. Researchers will compare differences in heart rate variability patterns between the groups and devise a machine learning algorithm to detect these patterns automatically.


Eligibility Criteria:
Inclusion Criteria:

* systolic heart failure (LVEF \< 35%)
* Atrial fibrillation without heart failure
* Individuals without cardiovascular disease

Exclusion Criteria:

* \> 85 years old
* Recent pulmonary venous antrum isolation procedure (\<1 year)
* (end stage) kidney failure
* (end stage) liver failure
* Study participants with known systemic active inflammatory disease
* Study participants with impaired mental state
* Inability to use a fitness tracker or mobile phone
* Impaired cognition and inability to understand the study protocol
Differential Acute Tolerance Development to Effects of Nitrous Oxide - 7

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine differential acute tolerance development to effects of nitrous oxide in humans.


Eligibility Criteria:
Please contact site for information.
Efficacy and Safety Study of XP12B in Women With Menorrhagia

The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.


Eligibility Criteria:
Inclusion Criteria:

* Women with menorrhagia
* 18-49 years of age
* Regularly occurring menstrual periods

Exclusion Criteria:

* History or presence of clinically significant disease or abnormalities that may confound the study
* History of bilateral oophorectomy or hysterectomy
* Hormone therapy
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority. Supporting caregivers to provide nurturing care is an evidence-based strategy, however feasibility of scaling-up this supporting is limited by competing demands on health workers' time. For infant development, mHealth technologies have the potential to solve this problem by providing tailored content directly to caregivers, involving and empowering them to promote infant development, promoting and facilitating interactions with health workers when areas of concern are identified and, therefore, expanding the reach of healthcare systems. This overall study is designed to explore this idea, by designing a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala in providing nurturing care and, after design, to conduct a prospective implementation trial of its use followed by an adequately-powered efficacy study.

Rationale: According to recent estimates, 43% of children under age 5 residing in low- and middle-income countries (LMICs)-250 million children in total-are at risk of not reaching their developmental potential due to living in environments with malnutrition, poverty, and lack of early stimulation. Mobile health (mHealth) technology represents an efficient strategy for scaling interventions to promote infant development.

Intervention: Pilot randomized controlled trial of mHealth application compared to paper caregiving materials. Length of intervention = 6 months.

Objectives and purpose: We will test a smartphone application that will directly engage caregivers in providing nurturing care to at-risk infants. We will assess effectiveness of the mHealth application compared to paper caregiving materials by establishing effect sizes of group differences in Bayley scores after 6 months.

Study population: parents of newborn infants, newborn infants.

Eligibility Criteria:
Inclusion Criteria:

* first-time caregivers with an infant in the eligible age range (0-4 weeks)
* infant from singleton birth
* infant from full-term (\> 37 weeks gestation) birth

Exclusion Criteria:

* Presence of acute malnutrition/wasting or severe medical illness (heart disease, kidney disease, congenital abnormality) in the infant
* medical need for supplementation of breastfeeding
* caregiver not literate
Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair

there are currently two methods for fixation free laparoscopic inguinal hernia repair specifically based on the intrinsic properties of the device used. The Progrip mesh technique leaves the hernia orifice patent and relies on the established principle of strengthening the groin through scar tissue incorporation induced by foreign body reaction. In contrast, the ProFlor concept introduces a 3D dynamic regenerative scaffold that permanently obliterates the defect and regenerates the herniated inguinal barrier. This report presents the outcomes of laparoscopic techniques employing Progrip and ProFlor in randomized clinical trial. The results of this clinical study may have the potential to pave the way for innovative advancements in hernia repair techniques.


Eligibility Criteria:
Inclusion Criteria:

* bilateral inguinal hernia

Exclusion Criteria:

* Recurrent inguinal hernia
* Incarcerated inguinal hernia
* Hernia not in the inguinal area
* Signs of obvious local or systemic infection
* ASA score \> 4
* Presenting with unstable angina or NYHA class of IV
* Pregnant
* Active drug user
* Immunosuppression, chemotherapy
* Chronic renal insufficiency
* Abdominal ascites
* Infection in area of the surgical field
* BMI \>34
Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg

The purpose of the study is to investigate the effects of food, in comparison to fasting conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and esomeprazole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults who provide informed consent prior to any study-related procedures. Females must be of non-child bearing potential.
* Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
* No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion Criteria:

* Recent history of any clinically significant illness as judged by the Investigator within two weeks prior to enrolling in the study
* History of heart, kidney, liver. or gastrointestinal disease considered to be significant as judged by the Investigator
* Moderate to heavy smoking or other nicotine use (greater than 10 cigarettes per day or corresponding amount of nicotine)
Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples

This study will enroll specimens from subjects diagnosed with various cancers and who have either:

1. RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within the local (or affiliated) pathology archive (replicate blocks from same tumor) or blocks no longer required to be maintained on file - discard blocks, or
2. PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to scheduled surgery, provide informed consent and donate a 10-20 ml blood sample. After surgery, surplus tissues (including tumor and adjacent normal tissues) not required for diagnosis will be collected.

Subject clinical information will be collected, including basic demographic information, medical history, current cancer history and treatment. A final pathology report will be obtained for each subject's surgical specimen. In some instances, and based on the cancer indications required, longitudinal data may also be collected at a frequency of every 6 months to once per year. Longitudinal data will include information on study subject survival and disease recurrence.

CANCER INDICATIONS:

Bladder Cancer - Urothelial carcinoma - nonpapillary Bladder Cancer - Urothelial carcinoma - papillary Brain Cancer - Astrocytoma Brain Cancer - Glioblastoma Brain Cancer - Medulloblastoma Breast Cancer - Ductal Carcinoma Breast Cancer - Lobular Carcinoma Cervical Cancer - Squamous Cell Carcinoma Colorectal Cancer - Adenocarcinoma Esophageal Cancer - Adenocarcinoma Gastric Cancer Head and Neck Cancer - Squamous Cell Carcinoma Hematologic Cancer - Acute Lymphocytic Leukemia (ALL) Hematologic Cancer - Acute Myeloid Leukemia (AML) Hematologic Cancer - Chronic Lymphocytic Leukemia (CLL) Hematologic Cancer - Diffuse Large B-cell Lymphoma Hematologic Cancer - Multiple Myeloma (MM) Hematologic Cancer - Non-Hodgkins Lymphoma (NHL) Kidney Cancer - Papillary Carcinoma Kidney Cancer - Renal cell Carcinoma Liver Cancer - Hepatocellular Carcinoma Lung Cancer - Adenocarcinoma Lung Cancer - Squamous Cell Cancer Melanoma Pancreatic Cancer - Ductal Adenocarcinoma Prostate Cancer - Adenocarcinoma Sarcomas Thyroid Cancer - Follicular Carcinoma Thyroid Cancer - Papillary Carcinoma Uterine Cancer - Endometrial Carcinoma

Eligibility Criteria:
Inclusion Criteria:

* Any adult age
* Any sex
* Able to provide consent for surplus tissue and/or blood donation
* Diagnosed with one of the cancer indications listed below:
* Scheduled to undergo surgical resection of tumor (exception for hematological cancers)
* Have not yet received treatment for cancer

Exclusion Criteria:

* Not diagnosed with required cancer indication
* Not scheduled to undergo surgical resection of the tumor
* Have already received cancer treatment (such as chemotherapy, radiation, surgery) for the current cancer or a previously diagnosed cancer
* Not able to donate an adequate volume of blood to meet minimum requirements
Colour Doppler Flow Imaging in Lacrimal Gland Lesions

Retrospective medical charts and medical imaging files review of patients suffering from lacrimal fossa lesions who underwent ocular ultrasonography with color flow doppler imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from lacrimal fossa tumor
* Orbital ultrasonography performed, including doppler flow imaging
* Histopathological characterization of the tumor obtained after surgical removal

Exclusion Criteria:

* Absence of histopathological characterization
* Absence of documented ultrasound doppler flow imaging