cyrilzakka/clinical-trials huggingface dataset:
Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)

Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without the need to perform other potentially time consuming investigations.

Hypofibrinogenemia is common in severe trauma and below the threshold of 2.3 g/l is associated with increased mortality. Although guidelines for management of the trauma induced coagulopathy does not recommend any specific timing of fibrinogen substitution, several papers suggest that early substitution might be associated with improved outcome. Laboratory measurement of plasma fibrinogen level, thromboelastometry and/or its estimation based on base excess, hemoglobin level, Injury Severity Score or combinations require diagnostic procedures that are associated with with a certain time delay and prolongs the time to fibrinogen substitution.

Eligibility Criteria:
Inclusion Criteria:

* patient having / suspected to have severe trauma transported to participating centers by cooperating Emergency Medical System organizations

Exclusion Criteria:

* possible alterations of plasma fibrinogen level in the time of trauma (inflammatory disease, malignant disease, pregnancy)
* administration of fibrinogen containing products (fresh frozen plasma, fibrinogen concentrate, cryoprecipitate) before sampling blood for fibrinogen level
* circumstances possibly interfering with plasma fibrinogen level measurement (prior the administration of hydroxyethylstarches)
Diabetes Homelessness Medication Support Program in Spanish

This single-arm trial of the Diabetes Homeless Medication Support intervention for Spanish-speaking people (n=12) will test the perception and feasibility of anticipated study procedures.

This study has an overall goal to modify and pilot test a previously developed collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and diabetes (DH). The intervention was developed in English. This study is intended to test the modified intervention for DH who speak Spanish (DH-SH). The study team's central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of DH-SH.

This protocol tests patient perceptions of the feasibility and acceptability of study procedures and refines the D-Homes treatment manual through test cases (n=12). The study team hypothesizes that the D-Homes manual and study procedures will be feasible and acceptable to DH-SH as measured by self-report and post-treatment interview.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 yrs or older
* Spanish-speaking
* Recent homelessness by federal definition (HEARTH ACT)

  1. Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)
  2. Significant housing instability in the last 24 mos. (includes any stay in shelter, outside, or places not meant for human habitation)
* Self-reported diagnosis of type 2 diabetes, later verified in medical record
* Plan to stay in local area or be reachable by phone for the next 16 weeks
* Willingness to work on medication adherence and diabetes self-care

Exclusion Criteria:

* Inability to provide informed consent (e.g. presence of a legal guardian, prisoners)
* Active psychosis or intoxication precluding ability to give informed consent
* Pregnant or lactating females
* Patients who choose to opt out of research
Exercise and Nutrition Interventions During Chemotherapy

This is a feasibility pilot study to initiate a research program to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the hands and feet).

This is a feasibility pilot study to help obtain external funding for a larger study to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (CIPN), which is a dose-limiting and painful side effect of chemotherapy for which there are no established treatments. The investigators will conduct a two-arm randomized clinical trial in 40 cancer patients receiving chemotherapy where Arm 1 is 12 weeks of exercise during chemotherapy and Arm 2 is 12 weeks of nutrition education (control condition) during chemotherapy. The investigators will acquire data on CIPN via patient reports and clinical assessments as well as general pain and hypothetical mechanistic factors that may help explain how exercise may treat CIPN; these factors include measures of musculoskeletal, cardiovascular, neuropsychological, and immunological function. The primary outcomes are related to the feasibility of identifying, recruiting, and obtaining complete data from research participants.

Eligibility Criteria:
Inclusion Criteria:

* Have non-metastatic cancer
* Be chemotherapy naïve
* Be scheduled to receive CIPN-inducing chemotherapy during the study (platinums, vinca alkaloids, taxanes, thalidomide, or bortezomib) for the duration of the intervention (12 weeks)
* Report symptoms of peripheral neuropathy at baseline (subject-reported severity of numbness and tingling in hands/feet of at least 1 on a 0-10 scale)
* Be able to perform the exercise intervention
* Be able to read English
* Be at least 18 years old (no upper limit on age)
* Be consistently right-handed in daily activities for consistency in reporting any lateralized effects from brain imaging
* Provide written informed consent

Exclusion Criteria:

* Receive surgery, radiation, or hormone therapy for their cancer during the study
* Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
* Have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, etc. - note that most port-a-caths are safe for MRI scanning)
* Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.
Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety and efficacy under these circumstances is sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as iloprost may be a favorable alternative therapy.

Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time.

Phase 2 - All remaining subjects received Iloprost as a continuous treatment.

The study was designed for an enrollment of 200 subjects and was ended early.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.
2. Indwelling arterial catheter.
3. Signed informed consent

Exclusion Criteria:

1. Clinically unstable circulatory condition requiring epinephrine \> 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)
2. Known hypersensitivity to prostacyclin compounds
3. Patients receiving sildenafil or bosentan
4. Refusal by the attending physician
ASSIST 2.0: a Reablement Program for Healthy Ageing

The goal of this study is to continue to develop, implement, and evaluate a unique reablement service, ASSIST 2.0. The project will determine the differences in the reablement service (ASSIST 2.0) compared to regular home care in terms of older adults' performance in daily activities, self-efficacy, perceived health, quality of life, frailty and perceived person-centered approach.

The research question is: Can older adults receiving ASSIST 2.0 improve their performance and satisfaction in daily life activities, experience a higher level of self-efficacy, perceived health, quality of life and a person-centered approach?

The ASSIST project involves older adults receiving home care, home care assistants, occupational and physical therapists. ASSIST 2.0 reablement consists of the following components:

* an intervention aimed at older adults to help them perform daily activities they need and want to do. This will be achieved through optimal support from home care staff,
* an on-line education provided by the researchers for all staff in the art and science of reablement,
* training and support through mentorship and coaching provided by occupational and physical therapists for home care staff to ensure the proper delivery of reablement.


Eligibility Criteria:
Inclusion criteria:

* Homecare has been granted
* The person can describe an ordinary day and what they have problems with doing
* 65 years of age or over

Exclusion criteria:

• The person has palliative care
Clinical Evaluation of Different Bulk-fill Composite Restorations on Posterior Teeth

Different bulk-fill composites will be applied in different posterior cavities then compared

Patients must be in middle age(25-55) age,able to regularly follow up,not pregnant and at least have 4 carious molars

Eligibility Criteria:
Inclusion Criteria:

* at least 4 carious molars

Exclusion Criteria:

* pregnancy patient
* Not able to regularly follow up
* bad oral hygiene
Minimal Psychological Intervention in Diabetes Patients

The purpose of this study is to determine whether the telephone-delivered Minimal Psychological Intervention (MPI) could improve diabetes' depressive symptom and diabetes-related immediately , as well as HbA1c level in the long-term.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Diabetes disease

Exclusion Criteria:

* Were using anti-depression medication
* With ongoing psychological/psychiatric treatment
* Had been diagnosed with psychosis (ex. schizophrenia or bipolar disorder)
* Had severe cognitive problem or hearing impairment
* Lost their partner within three months
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with active ulcerative colitis
* Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
* Either inpatient or outpatient

Exclusion Criteria:

* Patients who have a history of intestinal resection (other than appendiceal resection)
* Patients who have a complication of malignant tumor
* Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period
Ropinirole Tablets In Young Patients With Restless Legs Syndrome

This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).

Exclusion Criteria:

* Subjects who require RLS treatment during the daytime, suffer from other primary sleep disorders or are taking medication known to induce drowsiness, affect RLS or sleep, or to induce or treat alertness, including methylphenidate.
Profermin® in Active Ulcerative Colitis

In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a new online daily symptom registration system.


Eligibility Criteria:
Inclusion Criteria:Patients were eligible if they were between 18 and 50 years of age and had an established diagnosis of UC based on clinical, endoscopic and histological features. Active disease was assessed by Simple Clinical Colitis Activity Index (SCCAI) (Table 1) score above 4 and below 12.

-

Exclusion Criteria:

Patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or methotrexate within 8 weeks prior to inclusion or TNF-α inhibitors within 12 weeks before inclusion or had changes in UC treatment within 2 weeks before inclusion were ineligible for the study. Concomitant coeliac disease or lactose intolerance were also exclusion criteria. In addition any malignant or premalignant condition or recent gastroenteritis rendered patients ineligible-
Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding

The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)

This is a single-arm, multi-center study with three years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Female subject from (and including) age 30 to 50 years
* Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months
* Predictable cyclic menstrual cycles over past 6 months
* Excessive uterine bleeding
* Premenopausal at enrollment
* Normal PAP
* Normal endometrial biopsy
* Willing to use reliable contraception
* Not currently taking hormonal medication
* Agree to use sponsor provided catamenial product (sanitary pads/tampons)

Exclusion Criteria:

* Pregnant
* Desires future childbearing
* Presence of an IUD
* Previous endometrial ablation procedure
* Evidence of STI
* Evidence of PID
* Active infection of genitals, vagina, cervix, uterus or urinary tract
* Active endometritis
* Active bacteremia, sepsis or other active systemic infection
* Gynecologic malignancy
* Endometrial hyperplasia
* Known clotting defects or bleeding disorders
* On anticoagulant therapy
* Hemoglobin \<8gm/dl
* Prior uterine surgery
* Currently on medication that could thin myometrial muscle
* Severe dysmenorrhea, secondary to adenomyosis
* Abnormal uterine cavity
* Hydrosalpinx
* Uterine length \<6cm or \>12cm
* Currently in other clinical trial
Marijuana in Combination With Opioids in Palliative and Hospice Patients

Study Objectives: Primary reduction of pain and reduction in overall opioid utilization. Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.

Study Rationale: To determine optimum use and dosing of medical marijuana (CBD:THC) for pain and symptom management.

Study Population: This study specifically will enroll cancer and non-cancer patients as a primary diagnosis suffering from pain and having a terminal illness (defined as having less than 6 months to live) requiring end of life care.

Primary Endpoint: Primary reduction of pain and reduction in overall opioid utilization as evidenced by overall reduction in numeric pain scores and MME (Morphine Milliequivalents)

Secondary and Exploratory endpoints:Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting. Endpoints evaluation will be based on change from Baseline using the Modified Edmonton Assessment Scale.

Study design: This will be an open-label study. Patients will choose to participate in a Marijuana adjuvant treatment group, receiving marijuana in combination with standard opioid therapy.

Subject number: Minimum 66 patients

Treatment Duration: Minimum 5 days

Duration of follow up: Patients' initial opioid dose, dosing schedule and numeric pain score will be recorded. For the duration of the study (at least five days) changes in opioid doses and numeric pain scores will be tracked daily.

Marijuana will be administered to the patient via oral route three times daily for at least five days. Patients will receive standardized CBD:THC product provided by NIDA.

On admission to the study, a modified Edmonton Symptom assessment scale to quantify baseline appetite, depression, nausea, vomiting, overall well-being, and anxiety.

Data Tracking: Primary objective tracking will include average numeric pain scores and number of opioid dosage increases and average daily opioid amount (mg equivalents of morphine). Secondary objectives include Weight, Appetite, N/V, O2 Saturation, Self-reported data points from the modified Edmonton Assessment Scale.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Alert adults
* requiring opioids for pain management (routine)
* cancer diagnosis or non-cancer diagnosis as their terminal illness

Exclusion Criteria:

* pregnant women
* Age \< 18
* minimally or unresponsive patients unable to take oral medications
* agitated combative patients
Physiotherapy Protocols in Treating Plantar Fasciitis

This study aimed to investigate the efficacy of different physical therapy protocols in the treatment of chronic plantar fasciitis patients. Patients in this study were randomly assigned into 3 groups. Group A received ultrasound therapy protocol, group B received radial shock wave therapy protocol and group C received a combination of both ultrasound therapy and radial shock wave therapy protocol. All patients were also received a traditional physical therapy program. Foot function was evaluated by foot function index and ankle dorsiflexion range of motion was measured by Baseline® bubble inclinometer at the baseline and 4 weeks after treatment

Sixty nine patients having unilateral chronic plantar fasciitis will be recruited for the study from Al-Qurayyat General Hospital, in Al-Jouf Region, Saudi Arabia. The inclusion criteria were as follows: patients suffered planter fasciitis of more than 3 months, maximum tenderness near the medial calcaneal insertion and pain was greater than 4 on visual analogue scale during taking the first steps in the morning. Patients were excluded if they had previous ankle or foot surgery or pathology, or if they had a previous history of shock wave therapy or topical corticosteroid injections to the ankle or foot, circulatory disturbances in the lower extremities, neuropathic or radicular pain in the lower limbs. Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and gout, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study.

The patients were randomly assigned into 3 equal groups (n = 23). Group A received ultrasound therapy protocol using Enraf Nonius Sonoplus 490, Netherlands. Group B received radial shock wave therapy protocol using Swiss DolorClast® Master, Electro Medical Systems, SA, Nyon, Switzerland. Group C received a combination of both ultrasound therapy and radial shock wave therapy protocol. All patients also received a traditional physical therapy program (3 sessions per week, for 4 weeks) consisting of Calf muscles stretching and plantar fascia stretching. Foot function and Ankle dorsiflexion range of motion were evaluated at the baseline and 4 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffered plantar fasciitis of more than 3 months
* Maximum tenderness near the medial calcaneal insertion and pain was greater than 4 on visual analogue scale during taking the first steps in the morning

Exclusion Criteria:

* Bilateral plantar fasciitis
* Previous ankle or foot surgery or pathology
* If they had a previous history of shock wave therapy or topical corticosteroid injections to the ankle or foot
* Circulatory disturbances in the lower extremities
* Neuropathic or radicular pain in the lower limb
* Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and gout, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study.
Acupressure in Rheumatoid Arthritis

The goal of this pilot trial is to better understand if acupressure is feasible and tolerable to people with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

- Patient is being treated for Rheumatoid Arthritis (RA) at a Rheumatology Clinic at the University of Michigan or another by rheumatologist and reports being prescribed at least one of the following medications:

* Methotrexate (Trexall, Rheumatrex)
* Hydroxychloroquine (Plaquenil)
* Sulfasalazine (Azulfadine)
* Leflunomide (Arava)
* Tocilizumab (Actemra)
* Tumor necrosis factor inhibitor (TNFi), including:

Adalimumab (Humira) Etanercept (Enbrel) Certolizumab pegol (Cimzia) Golimumab (Simponi) Infliximab (Remicade)

* Abatacept (Orencia)
* Tocilizumab (Actemra)
* Janus kinase inhibitor (JAKi), including:

Tofacitinib (Xeljanz) Baracitinib (Olumiant) Upadacitinib (Rinvoq)

o Rituximab (Rituxan)

Exclusion Criteria:

* Visual or hearing difficulties that would preclude participation,
* Do not speak or read English
* Do not have access to smart phone with access to mobile applications
* Severe psychiatric disorders including history of substance abuse disorders,
* Individuals on high doses of opioids (over 100 oral morphine equivalents)
* Taking blood thinners, including warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)
* Thrombocytopenia (low platelet count)
* Expecting to receive surgery within the next year for their RA
* Pregnancy or breast feeding, or anticipate pregnancy in next year,
* Actively applying for disability or compensation, or actively involved in litigation.
* Anything at the discretion of the principal investigator or study team
Prevalence of Hyperprolactinemia in Systemic Scleroderma

Systemic sclerosis is an autoimmune and inflammatory disease characterized primarily by fibrosis and vascular involvement. We know that the immune system is disrupted in systemic sclerosis, but there are probably other mechanisms to explain the disease, including deregulation of certain proteins such as prolactin


Eligibility Criteria:
Inclusion Criteria:

Scleroderma patients:

* man or woman over 18 years old
* with systemic sclerosis meeting ACR-EULAR 2013 criteria
* having given his no opposition
* being social insured

Healthy subjects:

* man or woman over 18 years old
* donation of blood to the EFS
* matched on age (+/- 5 years) and sex
* having given his no opposition

Exclusion Criteria:

* Man or woman under 18 years old
* Pregnant or breastfeeding women
* Receiving medical treatment inducing dysfunction of the hypothalamic pituitary axis
* Refusing or unable to give no objection