cyrilzakka/clinical-trials huggingface dataset:
A Pragmatic Trial of the Consult for Addiction Treatment and Care in Hospitals (CATCH) Model for Engaging Patients in Opioid Use Disorder Treatment

This pragmatic clinical trial seeks to evaluate the effectiveness of the Consult for Addiction Treatment and Care in Hospitals (CATCH) intervention as a strategy for engaging patients with Opiod Use Disorder (OUD) in addiction treatment.

The overarching objective of our study is to evaluate the effectiveness of CATCH as a strategy for engaging patients with OUD in MAT. A pragmatic trial at 6 hospitals, conducted in collaboration with the New York City Health and Hospitals system (H+H) and the New York City Department of Health and Mental Hygiene (DOHMH), will study the CATCH intervention in real-world settings and at scale. Guided by the RE-AIM evaluation framework, this hybrid effectiveness-implementation study (Type 1) focuses primarily on effectiveness, but also measures implementation outcomes to inform the intervention's adoption and sustainability. A rigorous stepped-wedge cluster randomized trial design determines the impact of CATCH on opioid treatment outcomes in comparison to usual care for a control period, followed by a 12-month intervention period and a maintenance period, and utilizes existing administrative data to evaluate outcomes. Aim 1 (primary aim) is to evaluate the effectiveness of CATCH in increasing post-discharge initiation and engagement in MAT, defined respectively as receiving outpatient MAT within 14 days of discharge, and having at least 2 additional MAT visits in the first month. Aim 2 is to assess the effectiveness of CATCH for increasing treatment retention, defined as continuous receipt of MAT for 6 months. Aim 3 is to compare the frequency of acute care utilization and overdose deaths, and their associated costs, among patients with OUD who are hospitalized during the CATCH period versus usual care. Aim 4 is to evaluate implementation outcomes at CATCH sites using a mixed methods approach to assess the intervention's Reach (proportion of eligible patients reached); Adoption (utilization by medical staff); and Implementation fidelity (barriers to delivering high-quality MAT).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years);
* Hospitalized for at least 1 night on an inpatient service (not including intensive care);
* Admission or discharge diagnosis (based on ICD-10 codes) of opioid use disorder or opioid poisoning.

Cases are excluded if they received MAT (buprenorphine, methadone maintenance treatment, or naltrexone) in the 30 days prior to admission. Cases included in the intervention condition must have been admitted on a date following implementation of CATCH.

Exclusion Criteria:

* Lack of fluency in English, unable to provide informed consent.
Studying Gene Expression in Samples From Patients With Rhabdoid Tumors

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in samples from patients with rhabdoid tumors.

OBJECTIVES:

* To determine if BRM is silenced in the majority, if not all, rhabdoid tumors by immunohistochemistry in primary tumors.
* To determine if BRG1 is silenced in the majority, if not all, rhabdoid tumors by immunohistochemistry in primary tumors.
* To determine if GATA1 and/or HDAC2 is overexpressed in the same tumors that lack BRM expression.
* To determine if BRM promoter polymorphisms correlate with loss of BRM expression in primary rhabdoid tumors.
* To determine how BRG1 is silenced in primary rhabdoid tumors by sequencing BRG1 exons in genomic DNA derived from frozen samples.

OUTLINE: Archived tumor tissue samples are analyzed for BRM, BRG1, GATA1, and/or HDAC2 expression by immunohistochemistry. BRM- and BRG1-negative samples are also analyzed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tumor samples from patients diagnosed with rhabdoid tumors
* Matched frozen tumor tissue from BRG1-negative tumors (preferred) or matched genomic DNA from tumors, 100 ng per tumor from BRG1-negative tumors
* Any source of DNA from BRG1-negative tumors (tumors, blood, etc.)
* Matched frozen tumor tissue from BRM-negative tumors to confirm that BRM is not mutated or altered but rather epigenetically suppressed when lost in rhabdoid tumors

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Reproductive Outcome in Assisted Conception Cycles

Infertility is the failure to conceive after regular unprotected sexual intercourse for one year. Primary infertility refers woman who has never conceived, and secondary infertility to one who has had a previous pregnancy.The most frequent causes for infertility are ovulatory disorder or anovulation (27-30%) , tubal factor(20-22%), abnormal semen parameters(45-50%). Unexplained infertility refers to infertile couples in whom standard investigations, including tests of ovulation, tubal patency tests and semen analysis are normal. incidence 15-17% of infertile couples. New guidelines on infertility recommend that women with unexplained infertility should be advised for expectant management for 2 years .If pregnancy is not achieved after this period In vitro fertilization Should be considered. The Fast Track and Standard Treatment trial demonstrated A shorter time to pregnancy and higher per cycle pregnancy rates for In vitro fertilization compared with treatment with oral agents or gonadotropins in Patients with unexplained infertility. Successful pregnancy after assisted reproductive technology is influenced by numerous predictors that have been investigated in the previous years. The central predictors of success are the sperm, oocyte quality and endometrial receptivity. Oocyte quality depends mainly on the age of the woman , and her ovarian reserve. Parameters most commonly studied are the woman's age , her antral follicle count , and laboratory tests including serum randomly done during the menstrual cycle levels at day 3 of the cycle.


Eligibility Criteria:
Inclusion Criteria:

* in vitro fertilization treatment due to many factors including tubal, male, and unexplained factors.
* body mass index (BMI) (18-35)kg/m2

Exclusion Criteria

1. patient age less than 20 and more than 40 years.
2. body mass index less than 18 and more than 35 kg/m2.
3. period of infertility less than 2 years..
4. untreated hyperthyroidism, hypothyroidism, diabetes, hypertension.
Treatment of Periodontitis Using Er:YAG Laser vs. Conventional Treatment Modalities

Conventional non-surgical periodontal treatment, that is, root debridement using manual and ultrasonic means at baseline and surgery using the same means after 6 months in case of persistent deep pockets (Group 1)/ Er:YAG laser used in a non-surgical approach at baseline and surgery using the same laser after 6 months in case of persistent deep pockets (Group 2)/ Surgery at baseline using manual and ultrasonic means (Group 3). All patients will undergo supragingival maintenance on a yearly basis.


Eligibility Criteria:
Inclusion Criteria:

* at least 35 years of age
* at least 18 teeth present that can be retained by means of therapy among which 4 multirooted teeth or more(wisdom teeth excluded)
* presence of at least one deep pocket per quadrant (6 mm PPD or more) with radiographic evidence of bone loss (\>= 30% of root length)

Exclusion Criteria:

* pregnancy
* removable prosthesis
Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527

This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Use of other prescription drugs with 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
Iclusig PMS in CML or Ph+ALL Patients

This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP). This PMS is to assess safety and effectiveness data after administrating Ponatinib (of Iclusig® Tablets) per approved indication, usage and dosage.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are prescribed Iclusig® per Prescribing information (PI) for the purpose of treatment

Exclusion Criteria:

* Patients with known or suspected hypersensitivity to ponatinib or to any ingredient of the drug
* Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Multimodal Pain Treatment for Breast Cancer Surgery - a Prospective Cohort Study

Breast cancer is one of the most common types of cancer among women worldwide. (1) Breast-conserving surgery or mastectomy is indicated for the majority of patients with this type of cancer. (2) Postoperative pain is frequent in this population, with almost 50 % experiencing acute pain and 25-60 % subsequently live with chronic pain. (3-5) Today no golden standard for postoperative pain management regarding breast cancer surgeries exists, and there is definitely room for improvement. Especially considering the large population of women with breast cancer and consequences of acute and chronic pain, such as prolonged recovery and affected quality of life. (6,7) With the present study, we aim to optimise postoperative pain treatment and investigate the effect of a standardised multimodal postoperative analgesic regimen based on previous recommendations. (4,8,9)

All patients scheduled for breast conserving surgery or mastectomy with or without ALND or SLNB at Zealand University Hospital, Roskilde, will be invited to participate in the study. When the patients arrive for preoperative preparation on the day of surgery, one of the investigators will be responsible for a thorough oral information regarding the purpose of the study and all relevant participation requirements. The conversation will take place in a closed room, and the informed consent form will be obtained if the patient decides to participate.

Furthermore, patients will be informed that participation is voluntary and that a wish for withdrawal will be granted immediately.

The informed consent will grant the investigators direct access to data in the patients' electronic files to ensure the information necessary for the study. The patients also consent to complete the questionnaires in the seven-day follow-up period, and that the investigators can reach them by phone.

Completion of the study It is considered a completion of the study when a patient has signed the informed consent, has followed the treatment regimen, and answered the questionnaires in the seven-day follow-up period.

If a patient does not complete the study, an account should be given as to whether and how this subject's data is handled in the study - this also replies to drop-outs.

Reasons for withdrawal

- If a patient wishes to withdraw from the study In accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason. The investigators also have the right to withdraw a patient from the study at any time. The reason for withdrawal must be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for day-case unilateral breast conserving surgery or mastectomy +/- ALND or SLNB.
* Age ≥ 18 years of age.
* Patients who received written and oral information, and have signed the informed consent form on participation in the study.
* Patients living in the Region of Zealand.

Exclusion Criteria:

* Not able to speak, read, or understand Danish.
* Inability to cooperate and to consent.
Evaluation of Biocleanse Allografts For ACL Reconstruction

The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.

The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.

You are being asked to volunteer in a research study. The purpose of this study is to compare the different ways of cleaning allograft tendons used to replace the main ligament in the knee. The anterior cruciate ligament (ACL) is the main ligament in the knee that your doctor will replace in your surgery. The allograft tendons come from other people who have donated a tendon from the front of the knee after they died.

The three ways of cleaning the tendons that will be used in this study are BioCleanse, irradiation, and aseptic. Aseptic uses clean conditions when preparing the tissue for surgery, sometimes with a chemical bath. BioCleanse is a way of cleaning the tendon physically and chemically, while irradiation uses gamma rays. The goal is to clean the tendons to make them safer for the patients without weakening the tendon when put in the knee.

Eligibility Criteria:
Inclusion Criteria:

* ACL reconstruction

Exclusion Criteria:

* none
Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness.

The purpose of this study is to characterize and improve pain and nociception management in patients with disorders of consciousness (DOC). This project is divided into two phases, a first phase to evaluate pain level and a second phase which consist of a clinical trial to evalute pain medication efficacy.

The main aim is to evaluate the use of the Nociception Coma Scale-Revised (NCS-R) and its cut-off score (i.e., 5) as an assessment and management tool to define guidelines for managing pain in patients with DOC. In this double-blind, placebo-controlled clinical study, we will evaluate the use of analgesic treatments in reducing pain in subacute/chronic patients. The project will also allow us to validate the NCS-R cut-off score defined previously.

The study will be performed within one week (i.e, 7 days) and consists of two phases:

* Phase 1 "Patients selection (D0)": Patients will be assessed by the NCS-R during experimental stimulation (rest, tactile, noxious) and mobilizations (physiotherapy). Patients with potential pain will be included in the phase 2.
* Phase 2 "Analgesic administration (D1 and D2)": double-blind placebo-controlled randomized clinical trial on potential responders identified in phase 1. A medical doctor of our team will suggest to the physician in charge to prescribe the dedicated medication. One placebo and one real treatment will be administered on day 1 and 2 by the nurses at least half-hour before the physiotherapy. Randomization between day 1 and 2 will be applied at that time.

For each day of phase 1 and 2, several assessments will be performed: NCS-R, CRS-R and spasticity assessment.

Eligibility Criteria:
Inclusion Criteria:

* Have had an acquired brain injury with a loss of consciousness \> 28 days (patients) or have no history of previous brain injury (healthy controls)
* Legally authorized surrogate available to provide informed consent.
* Diagnosis of vegetative/unresponsive (VS/UWS) or minimally conscious state (MCS) or emergence of the minimally conscious state without communication (eMCS; as defined by the CRS-R, see above).
* Medically stable (i.e., no systemic illness or disease).
* Patients with NCS-R score during mobilization above or equal to the previously determined cut-off score or NCS-R scores during mobilization equivalent to NCS-R score obtain during nociceptive stimulation will be included in the second phase of the study (i.e. D1 and D2).

Exclusion Criteria:

* History of developmental, neurologic, or major psychiatric disorder resulting in functional disability.
* Contraindication or unwillingness to discontinuing sedating and centrally-active drugs (benzodiazepine, long-acting sedating drugs) within 48 hours of assessment.
* Upper limb contusions, fractures or flaccid paralysis.
* Uncontrolled epilepsy and already on level 1 drugs
TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse

Curvilinear incision in the postanal space, through the intersphincteric plane, insertion of Proctoscope of TEM technique and dissection till sacral promontory, insertion of mesh between the rectum and sacrum, post anal repair then anal cerclage width absorbable suture.

Perineal Rectopexy is performed by an incision in the intersphincteric space followed by dissection till the sacral promontory then Proctoscope is inserted to complete the dissection .Mesh is inserted and fixed to the sacrum with laparoscopic tacker ( or can be left unfixed) then postanal repair is conducted in two layers ( levatorplasty then sphincteroplasty) and finally Ana cerclage is done with polyglactin 0 sutures

Eligibility Criteria:
Inclusion Criteria:

* patients with complete or partial rectal prolapse

Exclusion Criteria:

* patients unfit for surgery
* patients with previous surgery for rectal prolapse
* patients with associated anorectal pathology (e.g fistula )
* patients with constipation as a predominant symptom.
Efficacy of IMPACT in Infant Siblings of Children With ASD

Over a 5 year period infant and baby siblings of children with autism spectrum disorders (ASD) will be recruited to this study and will be randomized into 2 groups. Parents of the intervention group will receive 12 weeks of coaching in how to implement this intervention. Parents randomized to the control group will not receive intervention coaching. Both groups will attend a series of clinic appointments for data collection that occur at 3 month intervals over a 9 month period.

This two-site randomized controlled trail (RCT) will include a sample of 80 siblings of children with ASD (Sibs-ASD) (11 months, 15 days to 18 months, 15 days) who are stratified on initial cumulative-risk status for communication disorder and then randomly assigned to Ingersoll's Improving Parents As Communication Teachers (ImPACT; Ingersoll \& Dvortcsak, 2010) treatment or to a business-as-usual (BAU) control condition. The following hypotheses will be tested:

1. Compared to the BAU Control, children assigned to the ImPACT group will show (a) more growth on pivotal skills and language level, and (b) a lesser degree of ASD symptomatology and language delay.
2. Pretreatment, cumulative-risk level will statistically interact with (i.e., moderate) treatment assignment to predict children's (a) change in pivotal skills and language, and (b) severity of autism symptoms and language delay.
3. Compared to the BAU Control, parents in ImPACT will have more optimal parenting stress and parenting efficacy, at least in parents with average or below average depressive symptoms prior to treatment (i.e., depressive symptoms will moderate the effect of ImPACT on parental stress and parenting efficacy).
4. The effect that ImPACT has on growth of pivotal skills and language will be mediated by parents' frequency and fidelity of use of ImPACT strategies at immediate post-treatment.
5. The effect of ImPACT on degree of children's language delay and ASD symptomatology at 6 months post-treatment will be mediated by their pivotal skill level at 3 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

Younger sibling of a child with ASD -

1. Age: 11 months, 15 days to 18 months, 15 days
2. Older biological sibling: Must have a diagnosis of Autism from UW or VU, which is confirmed via record review. If the older sibling was not diagnosed at UW or VU, then a diagnostic appointment must be made for the older sibling at the corresponding institution in order to confirm the diagnosis of ASD. Half-siblings are ok.
3. Vision - WNL corrected
4. Hearing - WNL corrected
5. Motor: The child must be able to sit independently while picking up objects and giving them to another person.

Exclusions:

No primary motor impairment. No feeding tubes. No other neurological or genetic conditions. Primary language exposure: The primary parent speak to the child using English 50% of the time, and process.
Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.

OBJECTIVES:

* To implement CyberKnife® technology for improving palliation in patients with spinal metastases.
* To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in these patients.
* To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after treatment with Cyberknife® radiosurgery.

OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.

Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.

After completion of study treatment, patients are followed periodically for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic spinal tumor

  * Localized spinal metastasis, defined as one of the following:

    * Solitary spinal metastasis
    * Two contiguous spinal levels

      * No more than 2 adjacent spinal levels involved by a single tumor
    * Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12)
  * Tumor size ≤ 5 cm

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Life expectancy ≥ 6 months
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must be ambulatory

Exclusion Criteria:

* Not pregnant or nursing
* No spinal instability
* No rapid neurological decline
* No bony retropulsions causing neurological abnormalities
* No total paraplegia for \> 48 hours
* No psychological issues that would preclude completion of study treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields
* No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance
* No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)