cyrilzakka/clinical-trials huggingface dataset:
Mobile Intervention for Suicidal Thoughts

One of the factors that contributes to suicide risk is what is known as a "suicidal belief system." This belief system is made up of several cognitions that been associated with suicide risk among military personnel. Modification of these cognitions may reduce suicidal thoughts and behaviors. The study team has developed a brief mobile intervention entitled the Mobile Intervention for Suicidal Thoughts (MIST) that uses evidence-based interpretation bias modification techniques to reduce these suicide cognitions. The goal of this project is to is to conduct a pilot trial of the MIST intervention to evaluate whether it is feasible an acceptable as an adjunct treatment for Veterans with suicidal ideation.

One of the factors that contributes to suicide risk is what is known as a "suicidal belief system." This belief system is made up of several cognitions, including hopelessness, thwarted belongingness, perceived burdensomeness, unlovability, unbearability, and unsolvability. These cognitions have all been associated with suicide risk among military personnel. Modification of these cognitions may reduce suicidal thoughts and behaviors. The study team has developed a brief mobile intervention entitled the Mobile Intervention for Suicidal Thoughts (MIST) that uses evidence-based interpretation bias modification techniques to reduce these suicide cognitions. The goal of this project is to is to conduct a pilot trial of the MIST intervention to evaluate whether it is feasible an acceptable as an adjunct treatment for Veterans with suicidal ideation.

The investigators will conduct a pilot randomized controlled trial (RCT), in which 50 Veterans with suicidal ideation will be randomized to either MIST plus Treatment as Usual and Safety Planning versus Treatment as Usual and Safety Planning. The central hypothesis is that Veterans will find MIST acceptable and will be willing to use it to reduce their suicidal thoughts.

Eligibility Criteria:
Inclusion Criteria:

* Veterans using the Durham VA Health Care System
* Endorsing suicidal ideation without intent in the last 30 days, established via C-SSRS
* Meet at least every 4 months with a mental health provider, established via chart review chart
* Can read at least 6th grade level material, established by their demonstrated ability to read the consent form and answer basic questions about it

Exclusion Criteria:

* Currently in a period of active psychosis or mania, established via the SCID-5
* Currently meeting criteria for a moderate or severe alcohol or substance use disorder, established via the SCID-5
* Endorsing suicidal intent, established via C-SSRS
* Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
* Have used the MIST intervention before as part of another research study
Effectiveness of Assessment and Educational Intervention on Motor Control of the Pelvic Floor Muscle in Women

The goal of the present study is to evaluate the short and long term effectiveness of a tailored assessment and educational intervention on motor control of the pelvic floor muscle in menopausal and non-menopausal women.

Menopausal transition has been related to stress urinary incontinence. The transition from the reproductive to the non-reproductive period is induced by a decrease in sex hormone production in the ovaries. Climacteric-stage oestrogen deficiency produces genital and urinary tract atrophy, which may be related to symptoms such as urinary frequency, urinary urgency, nocturia incontinence, and recurrent urinary tract infection. Urinary incontinence seems to appear due to a combination of factors such as pelvic floor weakness and tearing, denervation and fascial tears as well as both loss of motor units and altered activation patterns. However, physiotherapy can treat weakness and altered motor control in order to compensate for other factors. In fact, physiotherapy is considered the treatment of first choice.

Besides evidence defending physiotherapy as first line conservative therapy in incontinence due to influence of strength and motor control in this pathology and its prevalence in perimenopause women, little is known about its effects in this population. Hence, the aim of this study is to evaluate the short and long term effectiveness of a tailored assessment and educational intervention on motor control of the pelvic floor muscle in menopausal and peri-menopausal women.

Eligibility Criteria:
Inclusion Criteria:

* All participants in this study will sign an informed consent form prior their inclusion, and that whose participation will be voluntary

Exclusion Criteria:

* Participants will be excluded if they have any cognitive disability, physical disability or psychiatric limitations that could limit the participation on the study test
Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma

This aim of this study to evaluate the safety and efficacy of combining a single course of Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed Non-Hodgkin's lymphoma.

Relapse rates after chemotherapy for relapsed, refractory or transformed Non-Hodgkin's lymphoma (NHL)remain very high. NHL is a radiosensitive tumor. We hypothesize that targeted radioimmunotherapy combined with high-dose chemotherapy may increase response and survival rates in a safe and reliable manner.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18 to \<=70 years
2. Relapsed or refractory Stage III or IV, grade 1,2, or 3 Follicular Lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, or diffuse large B-Cell lymphoma as defined by the WHO and:

   * Expressing the CD 20 antigen
   * ECOG performance 0-2
   * Written informed consent
3. Prior collection of at least 2.5x10\^6 CD34-positive peripheral blood stem cells/kg.

Exclusion Criteria:

1. Abnormal renal function (Creatinine \>2.5x upper limit of normal (ULN)
2. Abnormal hepatic function (Bilirubin \>2xULN, ALT/AST \>3x ULN)
3. Cardiac ejection fraction \<40%
4. Severe defects in pulmonary function tests (DLCO\<70% predicted, FEV1, FVC\<60% predicted) or receiving continuous oxygen
5. A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy.
6. Female patients who are pregnant or breast feeding, and adults of reproductive potential who are not employing an effective method of birth control during study treatment
7. Prior radiotherapy to \>25% of the bone marrow or \>20 Gy to critical organ (lung, liver, kidney, spinal cord).
8. CNS lymphoma
9. Ongoing infection
10. Prior treatment with radioimmunotherapy
To Share Or Not To Share

The purpose of the study is to evaluate the group-based intervention "To Share Or Not To Share" in a German clinical setting. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.

People who have survived a suicide attempt often face public and self-stigma, and secrecy is a common strategy to minimize the risk of being labeled. Both secrecy and disclosure have pros and cons. The decision whether, when, and to whom to disclose a previous suicide attempt is complex. Interventions can provide guidance for systematic consideration and a well informed decision. Potentially, it may not be disclosure itself, but the empowered decision for or against disclosure of a previous suicide attempt that reduces distress and leads to beneficial outcomes.

The manualized peer-led group intervention "Honest, Open, Proud" (HOP) supports people with mental illness in their decision whether to disclose mental illness. Research showed positive effects of the intervention on stigma stress, disclosure-related distress and quality of life. Based on HOP, "To Share Or Not To Share" (2Share) was developed to systematically guide suicide attempt survivors through their decision whether and how to disclose a previous suicide attempt.

2Share led to significant reductions in self-stigma and depressive symptoms, as well as increased self-esteem in a recent pilot randomized-controlled trial (RCT) in the US. The aim of the current study is to evaluate 2Share in a German clinical setting. Feasibility and efficacy of 2 Share will be tested in a pilot RCT.

Eligibility Criteria:
Inclusion Criteria:

* Current inpatient, outpatient or day clinical treatment at the Bezirkskrankenhaus Günzburg, Germany
* Age ≥ 18 years
* At least one previous suicide attempt
* Positive screening for disclosure distress (1 item: "In general, how distressed or worried are you in terms of secrecy or disclosure of your suicide attempt?", self-report, persons with a score ≥ 4 on a scale from 1-7 are included)
* Written informed consent
* Sufficient German language skills

Exclusion Criteria:

* Current suicidality (1 item: "Have you had thoughts that you would be better off dead for at least several days during the last week?", self-report, persons responding with yes will be excluded and will be offered support)
* Suicide attempt within the last four weeks
* Dementia or organic disease (ICD-10: F0)
* Primary substance dependence (ICD-10: F1x.2)
Effectiveness and Safety of Fast Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight

This is a randomized controlled trial with infants less than 34 weeks and between 1000 and 2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d)

Progression of enteral feeding in preterm infants is still controversial. The neonatologist needs to provide adequate caloric intake avoiding the risk of food intolerance and necrotizing enterocolitis.

Objective: To establish the safety and effectiveness of fast enteral advancement compared with traditional advancement.

Design: A randomized controlled clinical trial with infants less than 34 weeks and between 1000 and 2000 grams at birth conducted at Hospital Universitario San Ignacio in Bogotá, Colombia.

Methods: 30 cc versus 20 cc / kg / day advancing in infants between 1000 and 1499g and 40cc versus 20 cc / kg / day advancing in infants between 1500 and 1999g.

Outcomes: days to reach full enteral nutrition, days of parenteral nutrition (PN) and/or intravenous fluids (IVF), days to regain birth weight, episodes of food intolerance, anthropometric measurements and weight gain at 40 weeks; rate of late onset sepsis, hypoglycemia, hyperbilirubinemia, necrotizing enterocolitis (NEC) and mortality. Data will be analyzed with Student t test or Mann-Whitney U-test and Pearson Chi-square or Fisher test. Multiple linear regression will be performed.

Ethics: This Protocol was approved by the Ethics and Research Committee of Pontificia Universidad Javeriana and San Ignacio Hospital. Informed consent will be requested to parents.

Eligibility Criteria:
Inclusion Criteria:

* Infants less than 34 weeks of gestational age.
* Weight at birth between 1000 and 2000 grams.
* Infants hospitalized in the newborn unit at Hospital Universitario San Ignacio in Bogotá, Colombia.

Exclusion Criteria:

* Perinatal Asphyxia
* Intrauterine Growth Restriction
* Diagnosis of Congenital Hearth Disease
* Severe Hypoxemia
* Major Congenital Malformations
* Metabolic Disease
* Intolerance to initiate oral feeding at the eligibility
* Patent Ductus with hemodynamic instability
* Early Onset Sepsis with hemodynamic instability
* Refusal of parents to participate in the study
Kombucha Tea for Improving Defecation in Patients With Schizophrenia- a Randomized Controlled Study

Patients with schizophrenia frequently have difficulties in bowel habits due to medical adverse effects and unhealthy lifestyle, and the use of various interventions to ameliorate the problems have been noted in clinical setting. Probiotics including Kombucha tea have been proved to modulate the human gut microbiota which may help to improve the stool passage, and have been attracting the public attention across the world. However, little is known among the patients with schizophrenia. In the present study, the research team intends to evaluate effectiveness of Kombucha tea when used in the clinical settings.


Eligibility Criteria:
* Inclusion Criteria:

  1. Inpatient patients diagnosed of schizophrenia according to DSM-5 criteria with the ICD-10-CM codes of F20.x. and hold the cards for Severe Illness issued by the National Health Insurance Administration, and
  2. Are currently and have been hospitalized at the psychiatric rehabilitation ward for more than 6 months, and
  3. Are at relatively stable psychiatric state and able to clearly express their perception or observed bowel conditions, and
  4. Are able to read or communicate with Mandarin or Taiwanese, and
  5. Are able to consent the agreements, and
  6. Subjectively experience difficulty in stool passage, such as decreased frequency, requiring medication or mechanic aids for defecating.
* Exclusion Criteria:

  1. Having an allergic history to fermented food, alcohol or other food, or 2. Severely impaired in cognitive performance, or 3. Having medications, antibiotics, probiotic or other fermented products that may influence gut microbiota at the time or within 3 months of the study, or 4. Having the illness that may affect stool passage or related with intestinal obstruction, such as severe gut disease, intestinal incarceration, tumor, inflammation, stenosis, or hemorrhoid, or 5. Having received major gastro-intestinal surgeries, or 6. Having the ongoing or history of medical illnesses, such as cancers, chronic obstructive pulmonary diseases, peripheral vascular diseases, autoimmune diseases, chronic kidney diseases, diseases involving abnormal metabolic function of visceral organs, or current infections, or 7. Participating other ongoing interventional research that may interfere the implementation or the results of present studies, or 8. Being obviously unable to comply with the execution of the study, or 10. Being declared of guardianship.
Application of Mixed Reality Technique for Percutaneous Lung Nodule Localization: A Prospective, Randomized, Controlled Trial

With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18years of age;
2. There was no distant metastasis in preoperative clinical evaluation;
3. The attending physician evaluated and confirmed the need for lung nodule localization and sub-lobectomy;
4. Target lung nodule diameter ≤ 2cm
5. The inner edge of the target node is at least 2 cm from the pulmonary artery or pulmonary vein
6. preoperative ECOG physical state score 0/1;
7. Volunteer to participate in the study and sign the informed consent form.

Exclusion Criteria:

1. More than two lung nodules need to be removed at the same time.
2. The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
3. The patient has uncontrollable mental illness and cannot make subjective assessment.
4. After being selected, severe complications (unable to tolerate surgery or anesthesia) occurred before operation are not suitable or the treatment plan of the study cannot be implemented as planned;
5. After being selected, the patient's condition changes and needs to be changed from elective surgery to emergency surgery after being confirmed by the competent doctor;
6. At any stage after entering the study, the patient voluntarily requests to withdraw or discontinue treatment due to personal reasons.
Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating

The purpose of this study is to assess the effectiveness of the prescription treatment compared to the non-prescription treatment. It is hypothesized that the prescription treatment will have a significantly greater effect than the non-prescription treatment on decreasing excess sweating.

The objective of this study is to assess the effectiveness of the prescription treatment compared to the non-prescription treatment. It is hypothesized that the prescription treatment will have a significantly greater effect than the non-prescription treatment on decreasing excess sweating.

Eligibility Criteria:
Inclusion Criteria:

* age 21-30 years
* males and females
* The subjects are in good health.
* The subjects have willingness and the ability to understand and provide informed consent for participation in the study.

Exclusion Criteria:

* Subjects with primary hyperhidrosis
* Subjects who are unable to withstand prolonged heat exposure or who have self-reported history of cardiovascular or respiratory disorders.
* Subjects who are unable to give informed consent.
* Subjects with mental illness.
* Subjects who are pregnant or nursing.
* Subjects with systemic or local skin disease and/or infection that may interfere with the conduct of the study.
Evaluation of Agreement Between CT Scan and 3D-DXA Measurements on the Lombar Spine

Dual-energy X-ray Absorptiometry is frequently used to measure bone mineral density. A new medical device, Box 3D DXA, creates a 3D image using a statistics reconstruction model developed on the femur. This new imaging technique does not require additional irradiation and ought to improve bone measures as well as incorporating densitometric parameters into the diagnosis. This study will test the reconstruction of the 3D image from lombar spine measurements and compare accuracy against measurements made using CT scan.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* The patient has been referred by a doctor for a PET/CT (Positron Emission Tomography-Computed Tomography) scan or a SPECT (Single Photon Emission Computed Tomography) scan in the Nuclear Medicine and Medical Biophysics Department of Nimes hospital or a bone scan including a SPECT/CT (single photon emission computed tomography coupled with a CT scan)

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patients is under judicial protection or state guardianship
* The patient is pregnant or breast feeding
* The subject has a observably serious scoliosis
* Subject has previously had spinal or hip surgery
* Subject weighs more than 200kg and/or is more than 2 meters tall by 5+65cm wide and 70cm diameter
* Patient uses an insulin pump or wears an insulin or morphine tubing or any attenuating equipment affecting the hips or lumbar spine
* Subject has already had an X-ray exam using a contrast product such as barium in the 7 days preceding the visit
* Subject having undergone γ radiation exam in the 15 days preceding the visit
Improving Patient and Family Centered Care in Advanced Critical Illness

One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care unit (ICU), typically following decisions made by surrogate decision makers to forego life prolonging treatment. A large body of empirical research has identified deficiencies in care processes that contribute to three important problems: 1) family members often experience poor quality communication with ICU clinicians, leading to lasting psychological distress associated with the ICU experience; 2) patients near the end of life frequently receive invasive, expensive treatment that is inconsistent with their values and preferences, and 3) end-of-life care is a major contributor to health care costs.\[8, 9\] Although advance care planning can prevent some unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis is uncertain, and therefore it seems likely that the need for interventions to improve "in-the-moment" decisions by surrogates will persist.\[10, 11\]

In a pilot project, the investigators developed the PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building), an interdisciplinary intervention that 1) gives new responsibilities and advanced communication skills training to existing ICU staff (local nurse leaders and social work members of the ICU team); 2) changes care "defaults" to ensure frequent clinician-family meetings; and 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings. The objective of this proposal is to conduct a stepped wedge randomized controlled trial testing the PARTNER intervention in 5 ICUs among 1000 patients with advanced critical illness and their surrogates.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Surrogate decision maker for ICU patient in one of 5 UPMC ICU's

Exclusion Criteria:

* Non-English Speaking
* Surrogate's loved one is for organ transplantation
* Not physically able to participate in family meeting