cyrilzakka/clinical-trials huggingface dataset:
Avaulta Versus Anterior Repair

Summary:

Vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. Consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the defect. However, many procedures are associated with a high recurrence rate up to 40 % even within one to two years after the surgical procedure.

Due to the high recurrence rate new methods include the use of mesh, either biologically or synthetic. The latter is a permanent implant and therefore theoretically may result in a long-lasting anatomically correct position of the prolapse.

Although the recurrence rate may be lower using a mesh such surgical procedures may be associated with adverse events such as erosions of the vaginal mucosa. Others have observed shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used. In contrast the recurrence rate is lowered up to 25%.

The above-mentioned advantage of synthetic mesh is however, mostly based on few non-randomised studies. We therefore find it of importance to evaluate whether a surgical procedure using a mesh implant is superior to conventional surgical techniques. The present study is a clinical controlled study where patients with anterior vaginal prolapse are randomised to either a mesh technique or a standard anterior procedure.

The present study includes only two more visits at the outpatient clinic after the surgical procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and faecal leakage and sexual habits.

Any participation in the study is totally voluntary and the patient may at any time withdraw herself. In any case the patient will receive our standard treatment.

The study is performed in all the Scandinavian countries.


Eligibility Criteria:
Inclusion Criteria:

* Women aged \> 55 yr
* Women with anterior vaginal wall prolapse stage \>2 according to POP-Q classification
* Good understanding the language in word and writing

Exclusion Criteria:

* A history of previous major pelvic surgery with the exception of a hysterectomy for reasons other than genital prolapse
* Patients with previous vaginal surgery because of defects in the anterior of posterior compartments
* Previous hysterectomy because of vaginal prolapse
* Patients with prolapse of uterus or an enterocele \> stage 2
* Patients with previous TVT performed through the obturator membrane
* History of genital or abdominal cancer
* Patients treated with corticosteroids
* Not able to understand the study protocol (language problems, cognitive dysfunction etc.)
Investigating Accelerated Learning in Tinnitus Participants Implanted With Vagus Nerve Stimulation

The purpose of this study is to investigate whether it is possible to accelerate learning and improve memory performance in VNS implanted tinnitus participants by pairing VNS with a verbal paired-associate learning task.

Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.

Vagus Nerve Stimulation (VNS) has been delivered to patient populations (e.g. depression, epilepsy, ...) for more than 25 years and there has been some indications that this technique has effects on cognition, more specifically memory. Studies have investigated VNS as a way to improve memory performance and it has been shown in some studies to enhance memory in rats and humans. It has also demonstrated to produce changes in the electrophysiological and metabolic profile of forebrain and brainstem structures involved in learning and memory.

To investigate whether VNS can accelerate learning and improve associative memory when learning word pairs, we will investigate the performance of VNS implanted participants on a Verbal Paired-Associate memory task and compare their performance on the words that were learned while paired with VNS in contrast to their performance on the words that were learned while unpaired with VNS and in contrast to their performance on the words that were learned without VNS (i.e. 3 types/groups of words: paired with VNS, unpaired with VNS and without VNS) during the first visit and 1 day,1 week and 1 month after their first visit.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* Native English speaker

Exclusion Criteria:

* Acquainted with the foreign language used in the learning task
Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study.

Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.

This clinical trial is prospective randomized phase III study of the efficacy of polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer. We will include in the study group 71 patients with colorectal cancer with ileo- and colostomy. In these patients we will do sublay/interoblique repair in prevention incisional hernias using polypropylene mesh. Our hypothesis is to reduce parastomal hernias rate from 30% to 10% over 2 years. Stratification will be used for patients with \>5 cm vs \<5 cm stoma-site hernia.

The control group will include 71 patients with similar parameters who will undergo stoma closure with layered ligature suturing of the abdominal wall without mesh implantation.

Additional endpoints are the wound infection rate, the complication rate (Clavien-Dindo), the rate of the repeated surgery for hernia at the site of stoma closure. We'll assess the quality of life by HerQLes (Hernia-Related Quality of Life Survey) scale.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Absence of distant metastases (M0)
* ECOG (Eastern Cooperative Oncology Group) status 0-2
* completed course of adjuvant treatment
* Absence of acute inflammatory parastomal complications
* Integrity of colorectal anastomosis

Exclusion Criteria:

* Inability to obtain consent to participate
* Synchronous and metachronous malignant neoplasms
* Clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system
* Parastomal inflammation and other conditions that increase the risk of postoperative complications
* Pregnancy
* HIV infection
Pain Education to Improve Cancer Pain Management Patients

Cancer pain is one of the problems of treating cancer pain. Although, there is a WHO analgesic ladder to improve this problem, it is still inadequate pain control. Pain does not affect only physical but also emotional and quality of life.

From review literatures we found that patients' knowledge about cancer pain management is inaccurate; for example, fear to use opioid, try to patience of pain, concerning only cancer treatments, which can cause of unfavorable pain management outcome.

Therefore, we will conduct the RCT of using pain education by video comparing to conventional face to face pain education by nurse in hospitalized cancer pain patients.We will use 25 MCQs examination for testing pre-post intervention to test level of understanding of patients. The measurements are NRS, ThaiHADs and FACT-G at the first and last day of study. We expect that NRS should improve more than 50% at the seven day of study.

protocol Randomized controlled trial study Sample size is 70 patients divided to 2 groups (35 for video group and 35 for conventional face to face group) Inclusion criteria

1. patients' age 18-70 years old
2. moderate to severe cancer pain
3. ECOG(Eastern cooperative Oncology Group) performance status \<= 3
4. Patients can write and read Thai language Exclusion criteria

1.Clinical unstability 2.Confusion and delirium 3.Bed ridden 4.Psychotic problem We will randomly allocate patients by using computer program nQuery advice 6.0. After patients sign inform consent we will record baseline characteristics, assess baseline Numerical rating scale (NRS), emotional status (ThaiHADs), Quality of life status (FACT-G). All patients will do the 25 MCQs test within 30 minutes before intervention. Video group will watch video 10 minutes and conventional group will receive pain education from trained nurse in the same period. The knowledge includes cancer pain definition, cancer pain management, pain assessment and role of patients in cancer pain management. After finishing intervention patients will the same 25 MCQs test (30 minutes) and patients can ask questions to the trained nurse.

All patients will be educated to record pain diary everyday for seven days. All patients will receive standard pain management from the physicians. At the day seven we will assess NRS, ThaiHADs and FACT-G and finish the study.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe pain (NRS\>4) cancer pain
* ECOG (Eastern cooperative Oncology group) performance status \<=3
* Can read, listen, write Thai language

Exclusion Criteria:

* Clinical instability
* Confusion and delirium
* Bed ridden
* Psychotic problem
Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone (BMT CTN 1705)

Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD


Eligibility Criteria:
Inclusion Criteria:

* Patients 12 years of age or older
* Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication
* Any graft or donor source or conditioning intensity
* Clinical diagnosis of acute GVHD requiring systemic therapy with corticosteroids

Exclusion Criteria:

* Prior exogenous AAT exposure for GVHD prophylaxis
* Relapsed, progressing, or persistent malignancy
* de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
* Receiving other drugs for the treatment of GVHD
* Receiving systemic CS for any indication within 7 days before the onset of acute GVHD
An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies

This was a study of INCB052793 given to patients with advanced malignancies that was to be conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine). Phase 1 had two parts; a dose escalation (Part 1) and an expansion (Part 2).


Eligibility Criteria:
Inclusion Criteria:

Phase 1a

* Aged 18 years or older
* Histologically or cytologically confirmed solid tumor or hematologic malignancy
* Life expectancy of 12 weeks or longer
* Must have received ≥ 1 prior treatment regimen
* Must not be a candidate for potentially curative or standard of care approved therapy

Phase 1b

* Aged 18 years or older
* Cohort A: Histologically or cytologically confirmed pancreatic adenocarcinoma, triple-negative breast cancer, urothelial cancer with at least 1 measurable or evaluable target lesion
* Cohorts B, C, D, E and G: Histologically confirmed multiple myeloma and measureable/evaluable disease
* Cohort F: Confirmed acute myeloid leukemia or myelodysplastic syndrome
* Cohort H: Individuals diagnosed with lymphoma
* Prior therapy:

  * Cohort A: No more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)
  * Cohorts B, C, D, E and G: Must have relapsed from or have been refractory to ≥ 2 prior treatment regimens
  * Cohort F: May have received any number of prior treatment regimens or be treatment-naïve
  * Cohort H: Must have relapsed from or have been refractory to available treatments

Phase 2

* Aged 18 years or older
* Cohorts I and J: Confirmed acute myeloid leukemia or high risk myelodysplastic syndrome
* Prior therapy:

  * Cohorts I and J: Must have failed prior therapy with a hypomethylating agent (HMA)

Exclusion Criteria:

* Prior receipt of a JAK1 inhibitor (Phase 1a only)
* Known active central nervous system metastases and/or carcinomatous meningitis
* Eastern Cooperative Oncology Group (ECOG) performance status \> 2
* Any known contraindications to the use of gemcitabine, nab-paclitaxel, dexamethasone, carfilzomib, bortezomib, lenalidomide, azacitidine, pomalidomide or PI3Kδ inhibitor (Phase 1b and Phase 2 only, as appropriate to treatment cohort)
* Known human immunodeficiency virus infection, or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation
Surveillance for Early Liver Injuries Caused by Xianlin Gubao Pill.

This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Pill (XLGB Pill) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Pill.

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Pill; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to XLGB Pill.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals in accordance with indications for XLGB Pill, including symptoms of osteoporosis;
2. The age range of 18 to 70 years；
3. Individuals taking XLGB Pill over 2 weeks;
4. Abnormalities of serum liver biochemistry achieving one of the criteria as follows:

   (i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;
5. Individuals can provide informed consent form.

Exclusion Criteria:

1. Individuals without indications for XLGB Pill;
2. Unconformity to the XLGB Pill drug label;
3. Individual taking XLGB Pill less than 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with XLGB Pill, simultaneously;
5. Unconformity to the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.
Safety and Tolerability Study of Multiple Doses of PF-06305591

Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects of non childbearing potential, between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, 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).
Positive Dementia Caregiving: Clinical Trial of an Online Training Program

The goal of this study is to learn if a new online training program is helpful to dementia family caregivers. This online program is fully computerized and supports 24/7 access from any location. The main questions it aims to answer are:

* Does the training program improves the participants' well-being and sense of positive meaning?
* If the program is found to be helpful, does it work through enhancing caregivers' self-belief or getting them to practice positive interpretation of caregiving challenges?

To answer these questions, researchers will compare the online program to a waitlist control.

Participants will:

* Use the intervention (requiring internet access) in a self-guided manner
* Respond to brief questionnaires at the beginning, and 1, 2 and 3 months afterwards

The Benefit-Finding Intervention is a type of caregiver intervention called psychoeducation with psychotherapeutic components. It combines standard topics of psychoeducation (e.g., training of care skills and stress management) with training on thinking style. As implied by the title 'benefit-finding', the training style in focus is the inclination to think alternatively and positively about challenging caregiving situations. In two clinical trials, the Benefit-Finding Intervention was compared with didactic psychoeducational programs but without thought training. This comparison allowed researchers to see if the addition of the benefit-finding component produced improvements over the above those achieved by standard psychoeducation. Results supported the superiority of the Benefit-Finding Intervention, with significantly greater reductions of depression and burden up to 10 months after the termination of the intervention.

A face-to-face intervention is nonetheless labor intensive. It may also cause inconvenience to caregivers who have to find blocks of time to attend the intervention, while making sure the care-recipient is being attended to. Having to travel to receive help is another challenge, especially for rural populations and older caregivers. The limitation of the face-to-face format was further exposed during the pandemic when such meetings were simply impossible. To address these issues, the original Benefit-Finding Intervention has been adapted for computer-automated delivery on a web platform, which is accessible anytime anywhere. The online intervention is not meant to replace traditional manned intervention, but as an alternative service for those who, for various reasons, cannot benefit from traditional interventions or who prefer the flexible, self-guided and self-paced approach offered by this intervention.

Eligibility Criteria:
Inclusion Criteria:

* Having been a dementia caregiver for 3 or more months
* Providing 10 or more hours of care per week
* Scoring 5 or above on the Patient Health Questionnaire-9
* Passing a simple reading comprehension test

Exclusion Criteria:

* Caregiver having participated in any training/therapeutic program on dementia care in the past year
* Care-recipient residing in an institution
A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults

Almost one in ten young adults report current e-cigarette use, putting them at risk of developing nicotine addiction and long-term health effects of exposure to inhaled toxicants. Despite the need for effective treatments to help these young users quit, very few treatments targeting any type of tobacco use among young adults have been evaluated, particularly for young adults who vape and have unique treatment needs. To address these needs, this trial will evaluate a digital program for young adult e-cigarette users at all stages of readiness to quit called ACT on Vaping.

OUTLINE:

Participants are randomized to 1 of 2 arms.

ARM I: Participants use the ACT on Vaping smartphone app and text messaging program and receive incentivized text messages assessing their vaping status.

ARM II: Participants receive incentivized text messages check-ins assessing their vaping status.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-30.
* Current weekly user of e-cigarette product(s).
* Owns an Android phone or iPhone.
* Has an email address.
* United States (US) resident, with a US mailing address.
* Willing to complete all study procedures.

Exclusion Criteria:

* Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatments is allowable during trial participation).
* Member of the same household as another research participant.
Education for Children Who Will Have Planned Surgery With Web-based and Therapeutic Game Method

This research was planned to determine the effects of the web-based education given at home to children aged 7-12 in planned surgeries and the therapeutic game method applied in the hospital on pre-operative anxiety and fear, postoperative pain and sleep.

This study is a randomized controlled experimental study.

Illness and especially hospitalization in the preoperative and postoperative period cause trauma with physiological, emotional and behavioral problems for children. With the help of web-based education and therapeutic game methods by pediatric nurses, anxiety, fear and pain seen in children and families can be reduced and skills to cope with negative emotions can be improved.

This research was planned to determine the effects of the web-based education given at home to children aged 7-12 in planned surgeries and the therapeutic game method applied in the hospital on pre-operative anxiety and fear, postoperative pain and sleep.

This study is a randomized controlled experimental study. The study is planned to be performed in the pediatric surgery clinic of the Training and Research Hospital.

For sample selection, children will be stratified in terms of age variables and divided into two strata as 7-9 years old and 10-12 years old. In order to ensure homogeneity between the groups, children will be selected into the study and control groups using a simple randomization method and a random numbers table. To the children in the study group and their parents; information about the child's surgery, educational brochures including the conditions to be considered before, during and after the operation, during the discharge period, operating room tour, educational games, etc. Training will be given on the website using and a therapeutic game will be played in the game room at the hospital the day before the surgery. The children in the control group and their parents will be given routine care and information about the pre-operative preparation in the service. Descriptive statistics, Chi-square test will be used in the evaluation of the data. A value of p\<0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research,
* Those who will have a planned surgery between the ages of 7-12,
* Having and able to use a computer/tablet and internet connection at home,
* Having the ability to use a computer / tablet,
* Pediatric patients given written consent by their parents

Exclusion Criteria:

* At least one previous experience of surgery
* Having communication problems (sight, hearing, mental),
* Diagnosed with anxiety disorder,
* Genetic/congenital disease,
MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)

A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients have type 2 diabetes mellitus
* On diet/exercise therapy

Exclusion Criteria:

* Patients have type 1 diabetes mellitus