cyrilzakka/clinical-trials huggingface dataset:
Group Intervention for Interpersonal Trauma

This study will assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder following interpersonal trauma exposure.

The aim of this study is to assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder (PTSD) following interpersonal trauma exposure. Group participants will be recruited from public sector/safety net primary care clinics. Study participants will be randomized to immediate or delayed treatment. Participants in both conditions will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. Groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. Each group session will focus on a different aspect of education. Next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. Each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier. Participants will be free to attend any of the sessions they missed during the first group when the group repeats. Participants in the delayed condition will be able to attend the groups after a 12-week waiting period. Assessments of PTSD, depression, functioning, and quality of life will be conducted at three time points: baseline (prior to the start of the group), 12 weeks after the start of the group, and 6 months from the start of the group. Gift cards will be sent to the women for completing each of the assessments.

Eligibility Criteria:
Inclusion Criteria:

* Exposure to an interpersonal traumatic event
* Diagnosis of depression or PTSD (threshold or subthreshold)
* Functional literacy

Exclusion Criteria:

* Apparent incoherence or disorientation
* Apparent intoxication at recruitment
* Hearing impairment
American Joint Replacement Registry

The American Joint Replacement Registry is a not-for-profit 501(c)(3) organization for data collection and quality improvement initiatives for total hip and knee replacements. The AJRR is a collaborative effort supported by the American Academy of Orthopaedic Surgeons (AAOS), the American Association of Hip and Knee Surgeons (AAHKS), The Hip Society, The Knee Society, hospitals, health insurers, medical device manufacturers, and contributions from individual orthopaedic surgeons.


Eligibility Criteria:
Inclusion Criteria:

* Any individual in the US undergoing total joint arthroplasty

Exclusion Criteria:

* None
rTMS in Aphasic Patients With Neuroimage Assessments

The refinement of repetitive transcranial magnetic stimulation (rTMS) has highlighted its merit in terms of learning programs as a treatment for aftereffect augmentation. Nevertheless, the efficacy of synchronous rTMS protocol integrated with computer-integrated speech training is not well understood. It is also not clear regarding the efficacy of compound bi-hemispheric stimulation protocol. The aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI and DTI microstructural evolution provides insight into underlined mechanism operating the language improvement.

The efficacy of synchronous rTMS protocol integrated with computer-integrated speech training is not well understood. It is also not clear regarding the efficacy of inhibitory or excitatory stimulation protocol. The aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI and DTI microstructural evolution provides insight into underlined mechanism operating the language improvement

Eligibility Criteria:
Inclusion Criteria:

* Aphasic stroke in chronic stage (over 3 months)

Exclusion Criteria:

* No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia
Naturopathic Treatment for the Prevention of Cardiovascular Disease

This study is designed to test the ability of a comprehensive naturopathic approach to reduce important risk factors for the development of cardiovascular disease. Treatment will take place over the course of one year and the comparator/control group will be followed by their medical doctors and be given conventional care.

Interventions will consist of an individualized treatment approach guided by an expert panel of clinicians who treat patients with cardiovascular disease. These interventions will consist of a combination of dietary, lifestyle and specific recommendations for supplementation. As this is a pragmatic study, blinding will not be attempted nor is appropriate.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* CUPW worker
* prescreening indicates higher than normal TC/HDL ratio

Exclusion Criteria:

* Experienced an MI or stroke within past 6 months
Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee

To prove the non-inferiority of DKM420 by evaluating the injecting efficacy and safety DKM 420 and control for patients who have osteoarthritis of Knee.

A multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority clinical study

Eligibility Criteria:
Inclusion Criteria:

* Men and Women who is over 40 under 80 ages.
* Diagnosed as osteoarthritis of Knee and satisfies the 3 of 6 ACR(American College of Rheumatology) conditions.
* Kellgren Lawrence grade (Ⅰ\~Ⅲ) at Visit 1 or within 24 weeks.
* 100mm VAS(Visual Analogue Scale) over 40mm.
* Etc.

Exclusion Criteria:

- Pregnancy and lactating women
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium.


Eligibility Criteria:
Inclusion Criteria:

* 16 years of age or older.
* Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.
* Can be obtained a specimen for bacteriological efficacy assessment.

Exclusion Criteria:

* Known or suspected hypersensitivity, intolerance or contraindication to Metronidazole, Ceftriaxone sodium, or other cephem antibiotics.
* Severe renal dysfunction (creatinine clearance \< 30 mL/min.) Reference: Cockcroft-Gault calculation formula.
* Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times upper limit of normal range values).
* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Barriers to Physical Activity in People With MS

Multiple Sclerosis (MS) is a chronic inflammatory disease leading to the demyelination of the central nervous system. Promoting physical activity has gathered attention as an effective means to improve health-related quality of life and to mitigate symptoms such as fatigue and depressive symptoms in individuals suffering from MS. However, persons suffering from MS often experience difficulties in staying active. A comprehensive understanding of barriers to staying physical active for persons with MS in Switzerland is currently lacking. Given the importance of physical activity in the context of MS a detailed understanding of this matter would be key for future research and treatment.

A key challenge when studying physical activity in the context of MS is to obtain objective and accurate measurements that are not prone to reporting bias. While accelerometer-based measurements hold promise in this regard they are not convenient for routine implementation in real-world environments. Initial research has identified consumer-grade wearables such as Fitbits as a promising alternative whereby focusing on the main outcome average step count. Given the rich detail of activity patterns that can be derived from such devices, research has so far underutilized the available information that has the potential to provide more comprehensive insight into this matter.

Objectives: The present project aims to determine the common factors in real-life settings limiting physical activity in persons with MS and the impact of these barriers on physical activity. Further, the present study aims to provide precedence for future research investigating physical activity in MS by examining the quality, reliability, internal consistency, and validity of PA metrics derived from the wide-spread consumer-grade activity tracker Fitbit in comparison to an accelerometer.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* definite diagnosis of relapsing or progressive MS (i.e., confirmed by their physician)
* persons with reduced walking ability but who are still able to walk independently with or without an assistive device (e.g., as expressed by an Expanded Disability Status Scale score between 3-6.5)
* possess a personal computer, mobile phone or a tablet with Bluetooth functionality,
* be willing and able to perform study procedures,
* be able to provide informed consent
* be able to answer the questionnaires in German.

Exclusion Criteria:

* serious illnesses that preclude safe participation in physical activity
* inability to follow study procedures
* inability to complete questionnaires in German
* inability to complete baseline questionnaires or activate the Fitbit device will lead to the exclusion of the participant from the study
Efficacy of Paracetamol in Addition to Morphine to Improve Analgesia in the Emergency Department

The purpose of this study is to test the additional effect of paracetamol in combination with morphine for analgesia, respectively to test/confirm an opioid sparing effect due to the additional use of Paracetamol, as well as the reduction of adverse drug reactions of morphine.

Paracetamol (acetaminophen) is widely used around the world for mild to moderate pain in all age groups. Prescription at the emergency department is very common and some studies suggest the use in alternative of Morphine, at least in the renal colic.

Morphine has also a complex analgesic effect due to inhibition of µ Receptors in the central nervous system and in the dorsal horn of the spinal cord. Morphine (like other opioids) is accepted as a cornerstone of acute pain management in the emergency department. However, occurrence of adverse drug reactions is up to 25%, mainly nausea and drowsiness.

The use of paracetamol in addition to morphine showed in a meta-analysis in the post-operative setting an opioid sparing effect of 20% over the first postoperative 24 hours, but did not change the incidence of morphine-related adverse effects in the postoperative period. An additive effect was showed of the two medicaments in another Study measuring the median effective analgesic dose (ED50).

The purpose of this study is to test the additional effect of paracetamol in combination with morphine for analgesia, respectively to test/confirm an opioid sparing effect due to the additional use of Paracetamol, as well as the to reduction of adverse drug reactions of morphine.

The study is a multicenter, randomized, double-blind, placebo-controlled. We randomize patients with pain-score \>=4 on a pain Scala of 0-10 Points (numeric rating scale) in two group, one with paracetamol, one with placebo to investigate the (additive) effect of paracetamol in combination with morphine. The treatment team and the patients will be blinded to the administration. The study design is outlined to confirm the result of previous studies who stated a 20% reduction of morphine doses when combined with paracetamol. Study duration for each patient would be 240 min.

Eligibility Criteria:
Inclusion Criteria:

* Patient with pain with Pain-score is more or equal than four in a numeric rating scale from zero to ten (i.e. indication for a treatment with morphine)
* Age over 18
* Signed informed consent. In case, patient is not able to sign the informed consent due to pain, at least verbal consent has to be provided. After pain relief, written informed consent with data and time has to be obtained

Exclusion Criteria:

* Analgesia in the past last 6 hours prior to visit at the emergency department
* Current Analgesia with long-acting/extended-release drugs
* Current Analgesia with opioids
* Chronic pain syndrome
* Contraindication for either paracetamol or morphine
* Patient's refusal of paracetamol or morphine treatment
* Pregnancy or Breastfeeding
* GCS \< 13
* SpO2 \< 90% with a maximum of 4 L/Min O2
* Systolic Blood Pressure \< 90 mmHg
* "Fast Track"/Notfallpraxis patients
Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients

This investigators will conduct a pilot study investigating the implementation of an infertility Patient Navigator (PN) program to mitigate challenges for underserved individuals at Boston Medical Center (BMC) seeking infertility care. The primary objective is to assess whether the PN program can significantly reduce time to completion of infertility evaluation and to initiation of fertility treatment (if recommended) for infertile patients from an underserved patient population.

The study aims are to:

1. evaluate the impact of the PN program on timelines including obtaining commercial insurance coverage for infertility, expediting labwork/imaging, weight management, and partner urology appointments, and initiating fertility treatment; and
2. ascertain the medical literacy of participants with a validated tool to assess the impact of low medical literacy on PN facilitation.

Participants will be contacted by the PN and provided with a survey instrument that will test their medical literacy. Then the PN will assist with scheduling cycle-based testing including labwork and uterine cavity evaluation, the partner's urology appointment, the patient's appointments such weight management/nutrition referral, mammograms (if indicated by age), and insurance counseling if the participant's current insurance does not cover infertility diagnostic testing and treatment. These tasks are part of pursuing fertility care at BMC.

Duration of evaluation and time to treatment in age-matched control patients from the year prior that did not have PN services will be utilized as a comparison group.

Regression analyses will be conducted to explore the association between utilization of a PN and pregnancy rates, considering potential confounding factors.

Establishment of the pilot program will enable the investigators to apply for a larger institutional patient care grant going forward. Strategies developed through this research can may enhance fertility care access for underserved communities across various healthcare settings. By tailoring interventions to populations not usually able to access specialized healthcare services, this study pioneers a paradigm shift towards inclusivity and equity in reproductive medicine.


Eligibility Criteria:
Inclusion Criteria:

Intervention cases

* A new patient at BMC Reproductive Endocrinology for the diagnosis of infertility from July 1, 2024 to January 31, 2025 Controls
* A new patient at BMC Reproductive Endocrinology for the diagnosis of infertility from July 1, 2023 to January 31, 2024.

Exclusion Criteria:

* Patients in whom fertility treatment with their own eggs is not recommended, egg freezing or oncofertility cycles.
* Non-English speaking
BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)

The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of PH1, per physician's determination

Exclusion Criteria:

* Currently enrolled in a clinical trial for any investigational agent
Assessing the Benefits of Robotic and Laparoscopic Surgery for Mid and Low Rectal Cancer in Patients: The Charlson Comorbidity Index (CCI)

This retrospective study collected participants who underwent robotic or laparoscopic anterior resection for rectal cancer at the North People's Hospital in Jiangsu from January 2019 to January 2023.


Eligibility Criteria:
Inclusion Criteria:

The criteria include: (1) pathology of low rectal cancer (within 10 cm from the anal margin); (2) access to comprehensive pathological and computed tomography (CT) data; (3) completeness of clinical data.

Exclusion Criteria:

patients with other malignant tumors besides rectal cancer, benign disease surgery, and emergency surgery.
Implementation of a Web-based Decision Aid for Breast Cancer Surgery

Routine incorporation of decision aids into oncology practice has the potential to significantly improve patients' experiences with cancer by increasing the likelihood that they make informed treatment decisions aligned with their values. Unfortunately, only a minority of the more than 1.6 million patients diagnosed annually with cancer ever receive one due to limited clinic resources for administration and challenges in timely identification of appropriate patients. Online delivery directly to patients addresses some of these barriers but is insufficient on its own to ensure accessibility for patients at the time they most benefit from support.19 It is critical that active, multi-faceted implementation strategies that target barriers to the widespread use of web-based decision aids be identified, as these tools have the potential to significantly improve the quality of oncologic care.

Based on strong preliminary work, the investigators have developed and piloted a package of implementation strategies that effectively overcomes barriers to delivery of a web-based breast cancer surgery decision aid in an academic and community clinic. Although the strategy was successful, patients were white and educated; further investigation is imperative in settings that provide care to underserved patients to ensure the intervention will mitigate, rather than worsen, existing disparities in breast cancer care. This is especially critical given that underserved patients may benefit most from shared decision-making interventions such as the one described. To study this, the investigators propose a pilot study within a clinic that serves a catchment area with a high proportion of African American, rural and low income patients. The investigators will iteratively assess and enhance our implementation package using concepts outlined in the Knowledge-to-Action Cycle, which emphasizes local context in balancing fidelity and flexibility. The specific aims are: 1) To identify patient and clinic level barriers to implementation of a web-based breast cancer surgery decision aid in a clinic that cares for underserved patients, and 2) To test and expand our current implementation package's ability to address barriers in a clinic that cares for underserved patients. The investigators will determine the reach of implementation and acceptability of this method of decision aid delivery to stakeholders.


Eligibility Criteria:
Patients:

Inclusion Criteria:

* Patients newly diagnosed with Stage 0-3 breast cancer.

Exclusion Criteria:

* None

Clinic Stakeholders:

Inclusion Criteria: clinical staff, clinic leadership, and surgeons involved in implementation Exclusion Criteria: none
SUPREME-DM (Diabetes Mellitis) Treatment Study

This multisite pragmatic clinical trial was designed to assess the effectiveness of a single scripted telephone call to diabetes patients who (a) were currently above recommended clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a new medication for that specific clinical domain. The goals of the intervention were to improve primary adherence and persistence to the newly prescribed medication and to improve control of glucose, blood pressure, and lipids.

This randomized trial tested the hypothesis that a telephone contact with a patient recently prescribed a new medication for uncontrolled glycated hemoglobin (A1c), blood pressure, or low-density lipoprotein cholesterol would improve (a) primary medication adherence, (b) medication persistence, (c) medication possession ratio, and (d) A1c, blood pressure or low-density lipoprotein cholesterol control. This study was part of the larger Agency for Healthcare Research and Quality funded SUPREME-DM study. The clinical trial reported here was coordinated and led by HealthPartners Institute for Education and Research, while data collection was coordinated through Kaiser Permanente Northwest and analysis was conducted at Kaiser Permanente Colorado. The clinical intervention sites for this study included Kaiser Permanente Northern California, Group Health Cooperative, Marshfield Clinic, and Geisinger Clinic.

Eligibility Criteria:
Inclusion Criteria:

* At each clinical intervention site, study subjects were selected if they:

  * were age 18-75 years
  * met study criteria for diabetes mellitus before study enrollment
  * received clinical care at a designated clinic or medical center involved in this study for at least 15 months before enrollment
  * were prescribed a new class of medication (not filled in the past 180 days) for A1c, BP, or LDL that was uncontrolled at the time of medication prescription (A1c\>=8%, systolic BP\>= 140 mm Hg, or LDL \>=100 mg/dL).

Exclusion Criteria:

* Study subjects were excluded if they were younger than 18 years of age
* Older than 75 years of age
* Did not have evidence of diabetes mellitus prior to study enrollment
* Were not receiving care at a clinic site involved in this study for at least 15 months before enrollment
* Did not have prescribed a new class of medication for uncontrolled A1c, BP or LDL.
Miami Membrane for Potency (MMEP) Trial

The use of dehydrated human amnionic membrane allograft improves erectile function recovery (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic assisted radical prostatectomy (RARP) compared to a control group with no allograft.

This is a phase 2 prospective randomized trial investigating the impact of amniotic membrane placement over the neurovascular bundles after bilateral nerve sparing robot assisted radical prostatectomy on potency. The study will have a control arm that will follow standard of care surgery, without placement of any membranes. 70 men will be allocated to each arm.

The research study will involve follow up every 3 months for the first 12 months. After this the investigators will follow patients annually with prostate-specific antigen (PSA) measurements and an assessment of any secondary therapies for 5 years post-surgery.

Randomization of study patients will be done in equal proportion to Arm I (membrane placement) and Arm II (no membrane placement, standard of care surgery) using a permuted block design stratified by baseline SHIM score (\<17 vs. \>=17), and use of ANY erectile aids (Yes vs. No) in the last 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve sparing RARP at the University of Miami

Exclusion Criteria:

* Men with poor urinary control at baseline requiring the use of pads for leakage
* Previous treatment for prostate cancer
* Previous history of pelvic radiation
* Men who are using non-oral erectile aids such as vacuum pump, intra-cavernous injections, MUSE, penile prosthesis.