cyrilzakka/clinical-trials huggingface dataset:
ACT for Weight-related Experiential Avoidance

This study aimed to investigate whether Acceptance and Commitment Therapy/Training would be helpful to reduce weight-related experiential avoidance among individuals who reported weight concern

This quasi-experimental study aimed to examine the efficacy of Acceptance and Commitment Therapy/Training (ACT) in reducing weight-related experiential avoidance. Data were collected with a convenience sampling technique. After obtaining ethical approval, participants were invited to participate in the study via advertisements, and online posts. Due to the small sample size, participants who were willing to attend group discussions were included in the experimental group. Participants in the control group did not receive manipulation. All participants were provided with an informed consent form. All participants completed a questionnaire measuring outcomes (weight-related experiential avoidance, general experiential avoidance, eating attitudes, and social physique anxiety) at pre-test, post-test, and follow-up. Participants in the experimental group received ACT training including 6 sessions. The protocol was adapted from Pearson et al. (2012) with their permission. Each session took approximately 80 mins. Several aspects of ACT approach were discussed in the sessions. In session one, ACT approach was introduced. In session two, creative hopelessness was discussed. In session three, control strategies related to weight concern were identified. In session four, mindfulness exercises were completed. In the fifth session, values for meaningful life experience were discussed. In the last, sixth session, the ways to commit to action were discussed. Each session included exercises and homework. At the end of the study, the participants were provided with debrief form.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who were 18 years and older
* Ability to read and understand Turkish

Exclusion Criteria:

* Individuals who have received mental health intervention over the last one year
* and those who were diagnosed with an eating disorder were excluded from the analyses
Safety and Efficacy of Pregabalin in Patients With Diabetic Peripheral Neuropathy.

To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Must have met the inclusion criteria for preceding double-blind study
* Must have received pregabalin or amitriptyline or placebo under double-blind conditions under double-blind conditions at least during first 3 weeks if double-blind treatment phase of preceding study.

Exclusion Criteria:

* Patients cannot be included if they experienced a serious adverse event while participating in preceding double-blind study, which was determined to be related to the study medication.
Omics Techniques in Fatty Liver Disease

Nonalcoholic steatohepatitis (NASH) is the most common cause of chronic liver disease in Western countries and one of the leading causes of liver transplantation in the world. Its spectrum ranges from simple steatosis to decompensated cirrhosis, resulting from progressive fibrosis due to inflammation and cellular injury. The reasons why patients with the same degree of steatosis have different evolutions are not sufficiently known. The objective of this project is to identify biomarkers that predict disease progression, using omics techniques, which can serve to develop new therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* Metabolic syndrome
* Liver steatosis detected on transient hepatic elastography performed in the last 12 months
* Steatosis with or without fibrosis confirmed histologically in a liver biopsy performed in the last 12 months

Exclusion Criteria:

* Concurrent liver disease (other than NAFLD)
* Chronic or prolonged use of any potential hepatotoxic drug or substance
* HIV infection
* Cancer (except basal cell carcinoma)
SVP Detection Using Machine Learning

This diagnostic study will use 410 retrospectively captured fundal videos to develop ML systems that detect SVPs and quantify ICP. The ground truth will be generated from the annotations of two independent, masked clinicians, with arbitration by an ophthalmology consultant in cases of disagreement.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years with presumed normal ICP undergoing routine dilated OCT scans.
* Patients undergoing a LP or continuous ICP monitoring with implanted transcranial pressure transducer devices at in- or out-patient neurology, neurosurgery or neuro-ophthalmology services.

Exclusion Criteria:

* Glaucoma diagnosis or glaucoma suspects in either eye.
* Bilateral restricted fundal view, e.g. advanced bilateral cataracts.
* Bilateral retinal vein or artery occlusion.
Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma

This is a open-label, dose escalation, multi-center, Phase I / Phase II study to assess the safety of an autologous T-cell product (ET140202) in adult subjects with advanced Alpha-fetoprotein (AFP) positive/Human Leukocyte Antigen (HLA) A-2 positive Hepatocellular Carcinoma (HCC).

The purpose of this study is to investigate a genetically modified autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ET140202 T cells are autologous T cells genetically modified to carry a TCR-mimic (TCRm) construct capable of mediating cell killing by targeting tumor specific intracellular antigens and addressing solid tumor therapy challenges.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent obtained prior to study procedures
* Histologically confirmed HCC with serum AFP \>200ng/ml at time of screening and following most current line of therapy OR radiographic diagnosis of HCC with serum AFP \>400ng/ml at time of screening and following most current line of therapy..
* Metastatic or locally advanced, unresectable HCC
* Must have failed or not tolerated, at least one line of systemic therapy for advanced HCC
* Molecular Human Leukocyte Antigen ("HLA") class I allele typing confirms participant carries at least one HLA-A2 allele
* Life expectancy of at least 4 months
* Karnofsky Performance Scale greater than or equal to 70
* At least 1 measurable lesion on imaging by RECIST
* Child-Pugh A or B7
* Absolute neutrophil count greater than or equal to 1,500/mm\^3
* Platelet count greater than or equal to 30,000/mm\^3

Exclusion Criteria:

* Clinically significant cardiac disease
* Clinically significant pre-existing illness or active infection
* Clinically significant Central Nervous System (CNS) or neural dysfunction
* Active autoimmune disease requiring therapy
* Active malignancy other than HCC unless expected survival is greater than or equal to three years without any treatment (exception: hormone/androgen-depravation therapy) and without any organ involvement
* History of organ transplant
* Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction
* Advanced HCC involving greater than one-third of the liver
Perfect Fit: Evaluation of a Virtual Coach for Smoking Cessation and Physical Activity

The leading cause of disease burden across the globe is cardiovascular disease (CVD). Important modifiable behavioral CVD risk factors include, amongst others, smoking and low physical activity (PA). Individuals with a low socioeconomic position (SEP) often have a less favorable profile of risk factors, resulting in a higher disease burden and premature death. There is a need for cost-effective multi-behavior interventions that target one or more risk factors. eHealth applications are increasingly being used to offer behavior change interventions. Potential benefits include accessibility, scalability, cost-effectiveness, and increased disease self-management. However, eHealth interventions are often static and thereby less effective, and also frequently developed without (sufficiently) engaging end-users. Involving end-users, including those from lower SEP groups, and other relevant stakeholders can help to optimize the adoption and adherence to the eHealth intervention and result in the maintenance of healthy behavior.

The Perfect Fit intervention is the result of interdisciplinary collaboration, and the personalized eHealth intervention supports adult smokers to stop smoking and increase their PA using a virtual coach. We primarily aim to examine the feasibility, acceptability and preliminary effectiveness of the Perfect Fit intervention.

A mixed-method single-arm pre-post intervention study will be used. The intervention, delivered through a virtual coach, has a personalized duration and intensity, but will last on average 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Current smoker (cigarette, cigar, or rolling tobacco)
* Intention to quit smoking between now and 6 weeks
* Being able to walk without pain complaints
* Being able to understand and read Dutch (B1 level)
* Having access to the internet and a smartphone

In addition, at least 50% of sample has ≥10% risk of CVD (Nederlands Huisartsen Genootschap, 2019), estimated on basis of:

- Being female and 55+ years old OR male and 50+ years old

Finally, at least 75% of sample is:

- Living in region Leiden (region between Leiden/Amsterdam/Utrecht)

Exclusion Criteria:

* Being involved in smoking cessation therapy/counseling at the start of the intervention.
* Has undergone major lower extremity surgery in the past year (to prevent giving PA advice that contradicts medical guidance).
* Taking antipsychotics or having a serious psychiatric illness (e.g., schizophrenia/psychosis, bipolar disorder, major depression).
* Being pregnant.
* Not able to wear the smartwatch throughout the day (e.g., when individuals are not allowed to wear a watch at work)
An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.

The purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg plus tamsulosin HCl 0.4 mg in the treatment of lower urinary tract symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.

The objective of this double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), parallel group trial is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg per day for 12 weeks in conjunction with an alpha-blocker for the treatment of lower urinary tract symptoms (LUTS). The hypothesis of the study is that oxybutynin extended release tablets 10 mg plus tamsulosin 0.4 mg will be more effective than tamsulosin 0.4 mg plus placebo in the treatment of lower urinary tract symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit. Safety assessments include Peak Flow Rate (PFR) and Post-Void Residual (PVR) volume, adverse events, vital signs and physical exams. Patients will receive oxybutynin extended release 10 mg plus tamsulosin 0.4 mg or placebo plus tamsulosin 0.4 mg every day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lower urinary tract symptoms with urgency and frequency with or without urge incontinence
* have had at least 4 weeks of 0.4 mg/day tamsulosin therapy
* an International Prostate Symptom Score (I-PSS) \>=13
* irritative component I-PSS score \>= 8
* max flow \>= 8ml/sec with voided volume \>= 125 ml, post-void residual volume \<= 150 ml on two occasions.

Exclusion Criteria:

* Clinically significant medical problems or other organ abnormality or pathology
* Prostate-Specific Antigen (PSA) \>= 4 ng/ml
* history of inability to empty bladder completely or not at all
* uncontrolled narrow angle glaucoma
* history of any prostate surgery or treatment
* history of significant gastrointestinal problems.
Men Engagement in Women Empowerment for Improving Maternal Mental Health Through Cash Transfer and Life Skills Building

This project aims to offer Life Skills Building (LSB) intervention to Benazir Income Support Program (BISP) Cash Transfer (CT) beneficiaries in couples in order to reduce domestic violence and depression and improve women empowerment in married women of reproductive age. The intervention will be carried out in the rural settlements of district Thatta, Sindh Pakistan.

The study will assess the impact of Life Skill Building (LSB) to Benazir Income support Program (BISP) Cash Transfer (CT) beneficiaries and their husbands in improving maternal mental and child health and its combined effect in empowering women and couples. The Formative phase of the project was dedicated for the development and modification of National level LSB curriculum for men and women. The formative phase was carried out in Thatta (Sindh), Rahimyar Khan (Punjab), Lasbela (Baluchistan) and Peshawar (KPK).

The intervention phase will be conducted in district Thatta, where BISP beneficiaries along with their spouses will be offered a LSB training. This intervention will be offered by community teachers to ensure sustainability and community trust. The participants will be recruited for baseline assessment followed by a comprehensive LSB intervention.The end-line follow up assessments (five months of intervention) will be done after the deliver of intervention. A qualitative summative inquiry will be done at the completion of the project to explore the overall impact of the LSB intervention. Since the project is being implemented with the BISP, the cost of intervention can be estimated for the scalability and sustainability.

Eligibility Criteria:
Inclusion Criteria:

* Adult married couples living together: where women receive Benazir Income Support Program (BISP) Cash Transfer (CT), have one child of at least 18 months and have no family migration plan for next 2 years

Exclusion Criteria:

* Gross mental impairment in either of the partners
* Either of the partner is physically challenged or bedridden
Outcome of Colonoscopy Screening and Surveillance

With this study, we plan to review the performance of colonoscopy in colon cancer screening and surveillance, especially with the recent improvements in endoscopic technology (high definition endoscopes), use of split dose preparation which provides excellent colon preparation for detection of lesions and increasing awareness and detection of flat lesions of the colon. The findings will help us define the role of colonoscopy screening of colon polyps and flat lesions and identity areas for improvement. The data will be used for continuing quality improvement and presenting our outcomes at academic meetings and publishing our results in peer reviewed journals.

Investigator's goal is to collect data from the endoscopy reports and clinic station reports to complete a descriptive analysis of the demographics, colonoscopy procedure performance, and assess the type of benign colon polyps detected during screening and surveillance from 02/01/2000 - 12/31/2020.

Specific variable to be reviewed:

1. Patient Demographics: Age, Sex, Race, Height, Weight, BMI (patient privacy will be acknowledged).
2. Indications for Colonoscopy (screening, surveillance, symptoms or tertiary referral \[EMR\])
3. Comorbid conditions: , cancer and surgical history, medical conditions,
4. Colonoscopy procedure; quality of colon preparation (using the Boston Bowel Preparation Scale) 0 - 3 for each section of the colon (Ascending, Transverse, Descending and Total Colon) , cecal intubation rate, cecal intubation and total procedure time, type of colonoscope (if CO2 was used in the procedure and techniques for colonoscope insertion, including position changes.
5. Examination findings: number of polyps and nature of polyps removed (site, size, surface, vascular pattern); type of polyp removed (serrated and sessile (flat) ; optical features and histology of polyps.
6. Resection techniques: biopsy, snare resection, endoscopic mucosal resection etc.
7. Including Pathology report findings so that a comparison can be made of the optical features and actual pathology report.
8. Outcomes of colonoscopy: adenoma detections (tubular and villous), cancer and quality metrics.
9. Outcome of colonoscopy: Complications (Bleeding and performance).

Eligibility Criteria:
Inclusion Criteria:

1. All Patients who have undergone colonoscopy for screening, surveillance or symptom evaluation.

Exclusion Criteria:

1. None
Ureteroscopy Combined With Negative Pressure Sheath Treatment of Kidney Stones

The removal rate, complication risk and operation time of ureteral soft scope combined with negative pressure suction sheath therapy for patients with high-load kidney stones (2-3cm) are still controversial. Therefore, what is the safety and effectiveness of ureteral soft scope combined with negative pressure suction sheath treatment for patients with high-load kidney stones and stones combined with infection? This study will help to solve the problems of safety and effectiveness of ureteral soft scope combined with negative pressure aspiration in the treatment of high-load kidney stones and kidney stones combined with infection, provide a more scientific treatment strategy for clinical practice, and promote the application of negative pressure aspiration technology in the field of ureteral soft scope lithotripsy, providing new means and ideas for individualized treatment.


Eligibility Criteria:
Inclusion Criteria:

150/5000

1. Patients diagnosed with kidney stones with a diameter of 2-3cm by CT;
2. Age \> 18 years old;
3. The anatomical structure of the kidney is normal, without deformity;
4. Unilateral or bilateral kidney stones are not treated at the same time
5. No serious heart and lung disease (ASA grade I-II)
6. Through preoperative communication, patients and their family members indicated that they were fully aware of the condition and the choice of treatment plan, and signed informed consent and informed choice notification;

Exclusion Criteria:

1. Simultaneous operation is required for ipsilateral ureteral calculi or contralateral upper or lower urinary calculi.
2. Severe coagulation dysfunction;
3. Previous history of ipsilateral upper urinary tract surgery;
4. Presence of urinary anatomic abnormalities or congenital malformations;
5. Patients who do not sign informed consent and cannot cooperate with the study;
PRORADIUM: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Radium-223.

PRORADIUM is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with radium-223.

This study is a prospective biomarker study of patients with mCRPC undergoing treatment with radium-223 as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male age ≥ 18 years
2. Histologically confirmed adenocarcinome of the prostate
3. ECOG Performance Status ≤ 2
4. Castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/mL (\< 2.0 nM).
5. Men diagnosed with at least one metastatic lesion on CT or bone scan.
6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
7. Patients who are candidates for standard of care treatment with Radium-223 55mBq/Kg very 4 weeks intravenously
8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
9. Acceptable hematological, hepatic and renal functions.

Exclusion Criteria:

1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
2. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
Mindfulness Based Stress Reduction Intervention

The aim of the current study is to find out the impact of Mindfulness based stress reduction intervention on psychosocial factors associated with distress tolerance and quality of life among youth . The study is conducted on the youth age ranging from 15-24 years from districts Mardan and Nowshera of KP. Standardized tools are used to screen highly vulnerable cohort for further intervention. Eligible participants who scored higher on psychological distress, vicarious traumatization, and low on distress tolerance and quality of life and show their consent were recruited for the Intervention Phase. Participants were assigned randomly to experimental and control groups in intervention phase. Participants in the experimental group were given Mindfulness Based Stress Intervention (MBSR) training in the settings conducive for research.


Eligibility Criteria:
Inclusion Criteria:

* The participants studying in different public and private sector higher education institutes of Mardan and Nowshera districts of KP.
* Participants who volunteer to participate were included.
* Participants with High psychological distress, and Vicarious Trauma.
* Participants with low distress tolerance and low quality of life.

Exclusion Criteria:

* Participants below 15 years or above 24 years i.e., the age range of youth (as recommended by WHO) will be excluded.
* Participants with any significant reported medical disease were also excluded.