cyrilzakka/clinical-trials huggingface dataset:
Treatment Development Targeting Severe and Persistent Negative Symptoms

People with schizophrenia often have problems with negative symptoms; expressing and identifying their emotions, their amount of speech, motivation and interests, feelings of purpose, social skills, and experiencing enjoyment. For this reason, new interventions are being developed to treat these problems. One new intervention is the Motivation and Engagement (MOVE) Program. The MOVE program is a new program which consists of weekly meetings for 9 months between a patient and a trainer. The weekly meetings will consist of goal setting and organization of the home to make daily tasks more manageable. During the weekly meetings the patient and trainer will discuss emotions and the trainer will help the patient identify their emotions.

The researchers hope to learn whether MOVE will help improve the problems. If it works the researchers will do a larger study comparing MOVE to other treatments that have addressed some of the problems already.

The therapist will ask you if the sessions can be audio taped to ensure that the therapist is doing a helpful job for you. They will also ask if the session can be video taped so that the tapes can be used to train other therapists learning about MOVE. The choice to do either of these is voluntary and you can continue to participate in the study if you choose not to have the session be audio and/or video taped.You will be provided a University Release document to provide that permission if you so choose.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female between the 18-60 who meet DSM-IV criteria for schizophrenia confirmed by the Structured Clinical Interview Diagnosis (SCID-P version). Outpatient status.
2. Receiving treatment with antipsychotic medication
3. Clinically stable for a minimum of 5 months prior to screening (no significant changes in schizophrenia symptomatology, depressive symptoms, or community functioning, no hospitalizations, emergency visits or incarceration due to symptoms of schizophrenia or depression, no medication increases due to symptom exacerbation)
4. Has clinically meaningful negative symptoms as indicted by a score of 4 or higher on at least 2 of 6 of the following symptom domains as rated by the NSA-16; restricted affect, diminished emotional range, poverty of speech, curbing of interest, diminished sense of purpose, and diminished social drive
5. No more than moderate positive symptoms as indicated by a score of 5 or lower on BPRS-E items measuring delusions and hallucinations and no more than a 4 or higher on conceptual disorganization
6. No more than mild depression as indicated by a score of 3 or lower on the BPRS
7. No significant movement disorder as indicated by a score of 3 or lower on the ESRS-A
8. Able to provide evidence of a stable living environment (individual apartment, family home, board and care facility with no plans to move in the next year)

Exclusion Criteria:

1. History of significant head trauma
2. History of a seizure disorder
3. Mental Retardation
4. Alcohol or drug abuse or dependence within the past 3 months
5. History of violence in the past one year
Immune Effects in Patients Treated With Whole Breast Irradiation

The purpose of this study is to obtain data to determine whether whole breast irradiation (WBI) differentially influences the frequency of components of innate and adaptive immunity and their relative functional activity, to assess the patient's quality of life (QOL) and to evaluate the cosmetic assessment of the breast on follow-up after WBI treatment.


Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to provide written informed consent and to comply with the study protocol as judges by the investigator.
* Patient has new diagnosis of breast cancer and has elected BCS and WBI. These patients must be consented prior to the start of WBI.
* For patients with invasive breast cancer sentinel node biopsy (SLNB) must be performed and confirm pathologic negative disease.
* Tumor size must be less than or equal to 3 cm.
* Patient is 45 years of age or older.
* Women of childbearing potential must agree to use adequate contraception prior to study entry and through the WBI treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

* Male patients
* Patients who are pregnant or nursing.
* Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the duration of the study or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
* Breast cancer that involves the skin or the chest wall.
* History of ipsilateral breast cancer treated with radiation therapy.
* Multicentric breast cancer in the ipsilateral breast as diagnosed by clinical exam, mammogram, ultrasound, or MRI
* Patients known to have a BRCA gene mutation. Genetic testing is not required.
* Patient with clinically positive nodal disease.
* Patient with proven nodal disease by either FNA, core biopsy or sentinel node biopsy.
Spironolactone Combined With Captopril and Carvedilol for the Treatment of Pulmonary Arterial Hypertension

The purpose of this study is to determine whether a larger dose of the aldosterone antagonist spironolactone combined with an ACE inhibitor (captopril) and a beta-blocker (carvedilol) is effective in reverse pulmonary artery remodeling in patients with pulmonary arterial hypertension (PAH)secondary to congenital heart disease

The pathogenesis of PAH involves multiple mechanisms. However, three common factors are thought to cause the increased pulmonary vascular resistance that characterizes this devastating disease: vasoconstriction, pulmonary vascular proliferation and remodeling, and thrombosis in situ. Advances in our knowledge of the molecular mechanisms involved in PAH suggest that endothelial dysfunction with chronic impaired production of vasoactive mediators plays a key role. Reduced production of vasoactive mediators, such as nitric oxide (NO) and prostacyclin, along with prolonged overexpression of vasoconstrictors such as endothelin-1 (ET-1), not only affect vascular tone but also promote vascular remodeling. Thus, these substances represent logical pharmacological targets. Animal studies showed ET-1 could stimulate aldosterone secretion in different species, both in vivo and in vitro. This stimulation involves the ET-B alone and both ET-A and ET-B receptor subtypes in rats and humans. Animal studies also showed spironolactone combined with ACE inhibitor could normalize blood pressure, prevents upregulation of vascular ET-1, restore nitric oxide (NO)-mediated endothelial dysfunction. Beta-blockers have ability to reduce dp/dt in pulmonary artery, as well as left ventricle, thus prevent further damage to the dysfunctional endothelium. Furthermore, we observed from our practice that the aforementioned therapy could lower pulmonary artery pressure in patents with pulmonary hypertension secondary to left ventricular dysfunction. Thus, we hypothesize spironolactone combined with ACE inhibitor and beta-blocker has the ability to reverse remodeling of pulmonary artery in PAH patients.

Eligibility Criteria:
Inclusion Criteria:

* A mean pulmonary artery pressure higher than 25 mm Hg or, when estimated by echocardiography, pulmonary artery pressure more than half the systemic artery pressure
* Congenital systemic-to-pulmonary shunts
Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders

OBJECTIVES:

I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.

PROTOCOL OUTLINE: This protocol describes several clinical studies of pharmacologic and dietary management in patients with urea cycle disorders.

Patients with carbamyl phosphate synthetase and ornithine transcarbamylase deficiency are treated with a low-protein diet, essential amino acids (for neonatal onset disease), caloric supplementation, oral sodium phenylbutyrate (now approved as a prescription drug 11/97), and citrulline or arginine free base.

Patients with argininosuccinic acid synthetase deficiency are treated with a low-protein diet, caloric supplementation, oral sodium phenylbutyrate (now approved as a prescription drug 11/97), and arginine free base.

Patients with argininosuccinic aciduria (AA) are treated with a low-protein diet, caloric supplementation, and arginine free base. (Discontinued 11/97) Any patient who develops hyperammonemia is treated with intravenous sodium benzoate, sodium phenylbutyrate, and arginine hydrochloride; benzoate and phenylbutyrate are not given to patients with AA.

If ammonium stabilizes at normal or near normal levels, intravenous medications are gradually replaced by oral medications. If there is no significant decrease in ammonium within 8 hours, patients begin hemodialysis.

Concurrent therapy with ondansetron, high caloric intake, and mannitol for elevated intracranial pressure is allowed. Dietary and intravenous nitrogen is prohibited. (Discontinued 11/97)

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Urea cycle deficiency, i.e.: Carbamyl phosphate synthetase deficiency (CPSD) Ornithine transcarbamylase deficiency (OTCD) Argininosuccinic acid synthetase deficiency (ASD) Argininosuccinic aciduria (AA)
Investigation of a New Rectal Catheter for Users of Transanal Irrigation

The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation.

The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark.


Eligibility Criteria:
Inclusion Criteria:

1. Has given written Informed Consent
2. Is at least 18 years old
3. Has full legal capacity
4. Has used Trans Anal Irrigation (TAI) with balloon catheter for at least 4 weeks prior to inclusion
5. Performs TAI minimum 3 times/week
6. Is able to follow study procedures assessed by investigator

Exclusion Criteria:

1. Has known anal or colorectal stenosis
2. Has active/recurrent colorectal cancer
3. Is within 3 months of anal or colorectal surgery
4. Is within 4 weeks of endoscopic polypectomy
5. Has ischaemic colitis
6. Has acute inflammatory bowel disease
7. Has acute diverticulitis
8. Is participating in any other clinical study that may interfere with this study (assessed by investigator).
9. Is pregnant or breastfeeding
Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

To evaluate the lon-term safety and tolerability of \[S,S\]-reboxetine in patients with fibromyalgia


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

Exclusion Criteria:

* Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:

Patients suffering from facet-joint-syndrome associated with lower-back pain will be treated with MRI-guided High Intensity Focused Ultrasound thermal therapy for pain relief.

Patients with diagnosed facet-joint-syndrome are suffering from severe pain in the respective regions, mainly lower-back pain. Eligible patients will be treated with High Intensity Focused Ultrasound (HIFU) under MRI control. The control by MRI assures on the one hand the correct selection of area to be sonicated and monitors in parallel the temperature, reached in the target area. The aim is to thermally ablate facet joint and/or medial branch nerves at lumbar spine. Ablation is deemed to be feasible and successful if temperatures of at least 57°C are reached at the target. The entire procedure will be done under anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain
* clinical diagnosis of Lumbar Facet Joint Syndrome
* eligible for MRI and MR-HIFU session
* eligible for general anaesthesia
* intact skin and soft tissue over treatment zone
* facet joint anatomy clearly identifiable
* patients must be able to discontinue all pain relief medication for a minimum of 48 hours prior to baseline assessment
* patients able to provide consent for the study

Exclusion Criteria:

* spinal implants
* treatment target zone \< 10 mm from the skin
* pregnant female patients
* breastfeeding female patients
* body weight \> 140 kg
* systemic and/or local infections
* moderate to high grade of spinal instability
* MRI contrast agent contraindication
* any MRI-unsafe implant or pacemaker
* facet joint anatomy which is not targetable or reachable due to scars, surgical clips, implants, or prosthesis in the planned beam path of the ultrasound beam
Clinical Performance Evaluation of KnowNow SARS-CoV-2 Test for the Detection of COVID-19 Antigen

This is an international, multicentre, non-interventional, observational study to assess the clinical diagnostic performance of a rapid, point of care (POC) COVID-19 (SARS-CoV-2) antigen In vitro diagnostic (IVD), The KnowNow SARS-CoV-2 Rapid Antigen Test, using saliva samples when compared to reverse transcription polymerase chain reaction (RT-PCR) as the standard detection of COVID-19 infection.

The KnowNow SARS-CoV-2 Rapid Antigen Test which uses saliva and is a lateral flow diagnostic device that can detect the SARS-CoV-2 specific Antigens that are present on the surface of the virus. The KnowNow test is an affordable, user friendly, and point of care device that can be mass produced as part of a multipronged strategy to address the global COVID-19 pandemic.

A saliva sample is collected from someone with suspected COVID-19 and mixed with a running buffer. The mixture is added to the sample pad of the KnowNow test, from where it migrates through the lateral flow strip. If COVID-19 Antigens are present, they bind to capture proteins on a test line and are made visible by secondary reagents within the device. The test result is visually assessed after 15-30 minutes and provides a binary positive (two lines) or negative (one line) result. Levels of COVID-19 Antigen differ dependent on disease progression. A visible test line (marked T) indicates the presence of COVID-19 Antigen in sufficient quantity in the collected sample to be detected. The appearance of the control line (marked C) confirms that the test has been performed correctly.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 years or over (or age of adult consent in some states within the United States).
2. Suspected COVID-19 infection and / or presenting with at least 1 recognised symptom Fever or chills. ie: Cough. Shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat
3. Be willing and able to comply with study procedures.
4. Be able to give written informed consent.

Exclusion Criteria:

1. Inability to give written informed consent.
2. Vaccinated against SARS-CoV-2
3. Adults unable to undertake the requirements of the nasopharyngeal or saliva sample collection for physical or psychological reasons
4. Subjects with other significant disease, condition, or at the Clinician's discretion.
Robotic Scope Cleaning Device

A novel device that works with robotic trocars to clean the scope when visualization is compromised during a surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* able to consent
* undergoing a surgical robotic procedure

Exclusion Criteria:

* not suitable for a surgical procedure with the robot
Correlation Between Pulmonary Rehabilitation and TFC

To study the effects of lung rehabilitation on the heart's hemodynamic performance of patients with chronic bidirectional lung disease when performing routine and regular PR, and found that the effects of lung rehabilitation on the heart mechanism and patients long-term quality of life research.

This study will be conducted in the Pulmonary Rehabilitation Treatment Room on the 6th floor of the Affiliated University Hospital. The acceptance conditions are: (1) treatment of chronic pulmonary obstructive pulmonary disease in the lung rehabilitation clinic, and (2) signing of the subject's consent; exclusion conditions: (1) tracheostomized patients, (2) patients who cannot perform conventional lung rehabilitation, (3) patients who use respirators at home.

The study is a prospective observational study. It is expected to include a total of 25 subjects. The study will be implemented for one year from the date of IRB adoption. Before performing PR treatment, performed the 6th and 12th Every month, routine lung function, six-minute walking tests, and non-invasive cardiac output measurements are performed. The main results are: cardiac hemodynamic parameters.

Eligibility Criteria:
Inclusion Criteria:

* treatment of chronic pulmonary obstructive pulmonary disease in the lung rehabilitation clinic
* signing of the subject's consent

Exclusion Criteria:

* gas-cut patients
* patients who cannot perform conventional lung rehabilitation
* patients who use respirators at home
Prevalence of Intrauterine Adhesions After Abdominal Myomectomy

Uterine fibroids are the most common benign tumors of the genital organs of women of childbearing age. Literature data show that more than 75% of women have fibroids.Symptomatic fibroids account for approximately over 200,000 hysterectomies and 50,000 myomectomies annually in the United States. Fibroids have a major impact on fertility, with significant adverse effect on implantation rate and spontaneous abortion rates when compared with infertile women without fibroids. The definitive treatment for uterine fibroids in a fertile patient is surgical excision. Although usually effective, myomectomy is not a risk-free operation, since the surgical procedure can cause mechanical infertility and can be associated with infection, injury to adjacent tissues, hemorrhage and need to convert to hysterectomy. A not often mentioned consequence of myomectomy is post-operative intrauterine adhesion formation. It has been reported that 50% of women undergoing open myomectomy are found to have intrauterine adhesions diagnosed by hysteroscopy performed 3 months after surgery. Such a high prevalence of intrauterine adhesions after open myomectomy is unexpected, however only few studies have addressed this topic.

It is accepted that injury to the endometrium is generally considered to be the primary causative factor for the development of intrauterine adhesions. The reason for such a high incidence of intrauterine adhesions after open myomectomy is unclear. It is speculated that infection or in adverted closure of the uterine cavity may play a role in intrauterine adhesion formation. The relationship between the number of fibroids removed and the risk of adhesions suggests a traumatic etiology. In the preservation of the uterus for the purpose of fertility, it is essential to also understand the impact of myomectomy on the endometrium. Currently no guideline recommends in office hysteroscopy as follow-up after myomectomy. The purpose of the present study is to evaluate the frequency of uterine adhesions following myomectomy and the impact of number, size and location of the fibroids as well as intraoperative breach of the endometrial cavity at the time of the myomectomy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of one or more uterine myomas
* Desire to preserve fertility/uterus
* Myomectomy (by laparotomy, laparoscopy or robotic approach).

Exclusion Criteria:

* Adults unable to consent
* Pregnant women
* Prisoners
* History of previous intrauterine procedures such as dilation and curettage
* History of known intrauterine adhesions
* History of documented pelvic inflammatory disease
* History of endometritis (acute or chronic)
* Hysteroscopic myomectomy
Which Health-care Professional(s) to Talk About Advance Care Planning ?

The goal of this descriptive observational study is to evaluate the preference of French adult patients followed in the context of a oncological disease, regarding the choice of the preferred healthcare professional to discuss advance care planning.

To this end, voluntary participants will be asked to indicate their preferences by answering a self-questionnaire available in electronic or paper format.


Eligibility Criteria:
Inclusion Criteria :

* Patients with neoplasic disease (under treatment, in exclusive palliative phase, under surveillance or in remission)
* French-speaking patients
Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.)

GLACIER (Giving Long Acting CABENUVA in an Infusion center/ASA) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting \[LA\] plus Rilpivirine LA) intramuscular (IM) in infusion centers/ASAs in United States. In this study, the intervention is the process of using an infusion center/ASA as the location to receive the CABENUVA IM injections. The acceptability and feasibility of the IC/ASA to deliver CABENUVA IM injections will be assessed from the perspectives of the participants, HIV care providers and IC/ASA staff. In this study, Month 1 is the Baseline visit. CABENUVA is a registered trademark of ViiV Healthcare.


Eligibility Criteria:
Inclusion criteria

* Adults (greater than or equal to \[\>=\]18 years old) at the time of signing the informed consent.
* HIV-1 infected and have been prescribed CABNEUVA per the United States Prescribing information (USPI).
* Participants can be enrolled
* If they have been taking oral VOCABRIA + EDURANT or other ART for approximately 1 month (at least 28 days) prior to Baseline/Month 1, or
* Already taking CABENUVA prior to Baseline/Month 1 and the last injections were within a 1 month +/- 7-day window or for every 2-month injections, the timing will vary if they are receiving the initiation injections (1 month +/- 7-day) or the continuation injections (2 months +/- 7 days) per the USPI, or
* Prescribed direct to inject and receive their 1st injection without an oral lead in at the Infusion Center/ASA on the last day of any other antiretroviral therapy
* Agreement to receive CABENUVA IM injections at participating infusion center/ASA.

Exclusion criteria

* Participants are excluded from the study as dictated in the Prescribing Information (CABENUVA \[USPI\]) in consultation with the HIV care provider.
* Contraindications, as per the current Prescribing Information \[CABENUVA USPI\]
* New health condition / prohibited medication reported - Other Reason at the discretion of the HIV care provider or IC/ ASA staff