cyrilzakka/clinical-trials huggingface dataset:
Asha HIV Health Promotion Intervention in India

The purpose of this randomized pilot study was to conduct an intervention with 68 rural women living with AIDS to compare the effectiveness of two different programs on compliance with HIV/AIDS treatment regimens, improvement in knowledge about HIV/AIDS and TB, improvement in psychological distress, reduction in stigma; satisfaction with care provided to family members, reduction in number of opportunistic infections, increase in CD4 levels and completion of the designed Asha-Life (AL) program. The trial was designed to assess the impact of the Asha-Life (AL) intervention engaging with an HIV-trained village woman, Asha (Accredited Social Health Activist), to participate in the care of women living with AIDS (WLA), along with other health care providers compared to a Usual Care group. Two high prevalence HIV/AIDS villages in rural Andhra Pradesh, which were demographically alike and served by distinct Public Health Centers, were selected randomly from a total of 16 villages.

This Community health study was conducted in two phases:

Phase I was initiated with the establishment of a Community Advisory Board (CAB) composed of 10 persons including WLA, Ashas, and health care providers consisting of Nurse Midwives, HIV and TB experts selected from a Primary Care Clinic in Nellore, Andhra Pradesh. The CAB considered issues related to stigma, disclosure, and psycho-socio-cultural factors affecting the health-seeking behaviors of WLA. They also analyzed the strategies that Asha could employ to support WLA in optimizing their health and well-being and that of their families. This was followed by focus groups conducted separately with the same type of participants. Eligibility criteria included WLA who were currently on ART, were 16-45 years of age, and were able to provide informed consent.

Phase II: A randomized control trial-pilot study was completed in Year 3. We assessed the outcomes of 34 WLA who participated in the AL program at six-month follow-up, as compared with 34 WLA in the Usual Care (UC) Program; in terms of: a) compliance with HIV/AIDS and/or TB treatment regimens (HIV/AIDS/TB), b) improvement in knowledge about HIV/AIDS/TB, c) improvement in psychological distress, d) reduction in stigma, e) reduction in number of opportunistic infections (OIs), f) increase in CD4 levels, and g) completion of the program. The intervention incorporated a comprehensive education and skills program to which we added high protein supplements (1 kg of Black Gram and 1 kg of Toor Dal/month for the AL group vs. a basic program including 1 kg of Channa Dal/month for the UC group.

Eligibility Criteria:
Inclusion Criteria:

* Women living with HIV
* Ages 18-45
* Interfacing with an Accredited Social Health Activist (ASHA)
* Receiving ART or eligible for receiving ART
* HIV Positive status
* CD4 cells ≥ 100
* Not a participant of Phase 1

Exclusion Criteria:

* Cognitively impaired, not a participant of Phase 1
Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate

According to clinical guidelines, endoscopic surgery (mono- or bipolar TURBT, laser resection, en bloc resection) is a standard treatment option for patients with primary non-muscle invasive bladder cancer (NMIBC) (excluding carcinoma in-situ). However, more than half of patients will experience local recurrence after surgery. It is believed that one of the main causes for this local recurrence is the reimplantation of tumor cells during endoscopic surgery. It is crucial to limit contact between the resected tumor and the bladder wall during the operation and to extract the specimen as quickly as possible. In the case of a small tumor, the surgeon can immediately remove it using an endoscopic instrument. There are a number of methods available for removing large tumors, but it is not yet clear which one is most optimal. Therefore, comparing the oncological results from evacuating bladder tumors using various methods is very timely.

Based on the previously mentioned studies, the investigators assume that the rate of bladder cancer relapse out site of the resection area would be lower in the morcellation group compared with piecemeal resection of the tumor. In order to prove this, the investigators plan to conduct a randomized study comparing the relapse rate in these two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for endoscopic bladder tumor removal
2. Non-muscle invasive bladder cancer on contrast-enhanced MRI or CT (stage cT1N0M0 and lower)
3. Diameter of tumor \>3cm

Exclusion Criteria:

1. Patient refused to participate in the trial
2. Multiple (more than 2) bladder tumors
3. Previous cold-cup biopsy or any other surgery for bladder tumor
4. Muscle-invasive bladder cancer on postoperative histological evaluation
5. Other malignant/benign tumors of the bladder (non-urothelial cancer)
Optimal Timing of Hepatitis B Vaccination After Transplants

The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity effect of two different vaccination schedules (initiated at 3 or 6 months after transplantation) in patients with different immune reconstitution status.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be ≥ 16 years old;
2. Patients receiving hematopoietic cell transplantation;
3. Patients achieving complete molecular remission;
4. Patients or their guardians have to sign an informed consent form before the start of the research procedure.

Exclusion Criteria:

1. Multiple transplantations;
2. Donors' HBV-DNA or HBsAg are positive;
3. Patients' HBV-DNA or HBsAg are positive before transplantation or \< 3 months after transplantation;
4. Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions;
5. Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.
EffecT of eARly analGesia With Erector Spinae Plane Block to Reduce Ventilation After Severe Chest Trauma

Blunt chest trauma is commonly associated with rib fractures and early pain management is a key goal after chest trauma. In spontaneous breathing patients, pain limits coughing efficiency and secretion clearance, thereby potentially leading to progressive atelectasis, loss of functional residual capacity (FRC) and, ultimately, respiratory distress. In patients under mechanical ventilation, pain interacts with the weaning of mechanical ventilation inducing an increase of the duration of invasive ventilation. According to recent French guidelines for chest trauma management, immediate analgesia is initially performed by intravenous multimodal analgesia followed by a thoracic epidural analgesia or a paravertebral block if the pain is not controlled within the first 12 hours. However, these blocks necessitate an experienced anaesthesiologist, are at risk of severe complications and are contraindicated in case of post-traumatic coagulopathy. All these considerations limit their indication in the trauma bay. The erector spinae plane (ESP) block is an easy to perform, ultrasound guided, regional anaesthesia for pain management after thoracic surgery. This block can be made continuously with a dedicated catheter for a continuous infusion of local anaesthetic drug with boli. The ESP block is performed by depositing the local anaesthetic in the fascial plane, deeper than the erector spinae muscle at the tip of the transverse process of the vertebra. This block is less invasive with fewer contraindications as compared to epidural analgesia or paravertebral blocks. After chest trauma, ESP block was associated with an improvement in respiratory capacity in a retrospective study. However, there is no randomised control trial assessing ESP efficacy. Our hypothesis is that early continuous ESP block in the trauma bay decreases the number of days with invasive and/or non-invasive ventilation after chest trauma.


Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years

Blunt chest trauma with 3 or more rib fractures on Thoracic CT scan

With spontaneous breathing or under mechanical ventilation in the trauma bay

Requiring an intensive (or intermediate) care unit admission

Exclusion Criteria:

Pre-hospital cardiac arrest

Patient not expected to survive within the first 72 hours

Uncontrolled haemodynamic instability despite initial resuscitation (systolic arterial blood pressure lower than 90 mmHg at the time of catheter insertion)

Mechanical ventilation for severe traumatic brain injury (Abbreviated Injury Score, AIS, head \> 2)

Spinal cord injury at the cervical or thoracic levels

Hypovolaemia.

Hypersensitivity to ropivacaine or other amide-bound local anaesthetics

Subject in exclusion period of another interventional study

Pregnant, breastfeeding women
Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability

Repetitive transcranial magnetic stimulation is a non-invasive neuromodulation technique used to treat different neuropsychiatric disorders, such as, depression, neuropathic pain, fibromyalgia and obsessive-compulsive disorder. It is known that the heart rate variability is altered in these conditions. Therefore the focus of this research is to show the influence of rTMS on the Heart Rate Variability.


Eligibility Criteria:
Inclusion Criteria:

* Agreed participate the protocol
* Signing the consent form
* Do not present any cardiac problems or disease

Exclusion Criteria:

* Trauma of Skull, epilepsy don't treated,
* Use of medications decrease the seizure threshold
* Patients in use of drugs, how cocaine and alcohol
* Neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
* Pregnant or breastfeeding women
Exploratory Study of NS-089/NCNP-02 in DMD

This study is designed to assess the safety, tolerability, efficacy and pharmacokinetics (PK) of NS-089/NCNP-02 in subjects diagnosed with Duchenne muscular dystrophy (DMD), and to determine the dosage for subsequent studies.


Eligibility Criteria:
Inclusion Criteria:

* Has an out of frame deletion(s) that could be corrected by skipping exon 44 as confirmed by any of methodology at the time of visit 1. If not confirmed by any of methodology that evaluates the relative copy number of all exons (i.e. MLPA etc), must be confirmed through these techniques by the time of visit 3.
* DNA sequencing of exon 44 confirms that no DNA polymorphisms occur that could compromise duplex formation between NS-089/NCNP-02 and pre-mRNA.
* Male and \>= 8 years and \< 17 years of age at the time of obtaining informed consent and/or assent. Subjects aged \>= 4 years and \< 8 years can be enrolled according to the circumstances.
* Able to give informed consent in writing signed by parent(s) or legal guardian who is able to understand all of the study procedure requirements. If applicable, able to give informed assent in writing signed by the subject.
* Life expectancy of at least 1 year
* Able to ambulate. Non-ambulant subject can be enrolled according to the circumstances.
* Have intact muscles, which have adequate quality for biopsy. (No lacks or severe atrophy of biceps brachii or tibialis anterior muscle)
* QTc \<450 msec (based on 12-lead ECGs), or \<480 msec for subject with Bundle Branch Block.
* Glucocorticoid-naive patients, or patients who have used systemic glucocorticoids for at least 6 months prior to enrollment in this study with no dose changes for at least 3 months prior to enrollment.

Exclusion Criteria:

* Has participated in other pharmacological clinical trial that might recover dystrophin protein by the readthrough or the exon-skipping therapy, and/or upregulate the dystrophin-associated proteins such as utrophin.
* A forced vital capacity (FVC) \< 50% of predicted.
* Continuous use of artificial respirator (except for use of NPPV while sleeping)
* A left ventricular ejection fraction (EF) \< 40% or fractional shortening (FS) \< 25% based on echocardiogram (ECHO).
* Surgery within the last 3 months prior to the first anticipated administration of study medication or planned for anytime between visit 1 of Part 1 and the last visit of Part 2.
* Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody test (HCV), or human immunodeficiency virus (HIV) test at screening.
* Current diagnosis of any immune deficiency or autoimmune disease.
* Current diagnosis of any active or uncontrolled infection, cardiomyopathy, or liver or renal disease.
* Use of any other investigational agents and/or experimental agents within 3 months prior to the first anticipated administration of study medication.
* History of any severe drug allergy.
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.

To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.

This trial is a single arm, prospective, multi-center, non-randomized and open-label post-market study that will evaluate subjects for up to 5 years post treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \> 18 years old
2. Presence of severe MR as read on a transthoracic echocardiographic study
3. Mitral leaflet coaptation surface is sufficient to reduce mitral regurgitation without undue leaflet tension (approximate leaflet to gap ratio of 2:1) based on the judgment of the patient eligibility committee and the operating surgeon
4. Degenerative mitral valve disease with mid-segment P2 prolapse
5. Patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation

Exclusion Criteria:

1. Patient is of the age where further growth is expected
2. Active endocarditis
3. Left ventricular or left atrial appendage thrombus
4. Severe mitral annular and/or leaflet calcification
5. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen
6. Mitral stenosis
7. Functional Mitral Valve disease
8. Previous mitral valve replacement surgery
9. Fragile or thinning apex
10. Contraindications to transoesophageal echocardiography (atlantoaxial disease, severe generalized cervical arthritis, upper gastrointestinal bleeding, significant dysphagia and odynophagia, has received extensive radiation to the mediastinum)
11. Patient is pregnant or lactating
Haptoglobin Phenotype and Cardiovascular Complications in Diabetic Patients

3054 diabetic patients were screened for Haptoglobin Phenotype as part of the ICARE study (NCT00220831) and composite the I CARE Registry, 1434 Hp 2-2 patients were treated as part of the I CARE study with vitamin E vs. Placebo, this study was recently terminated due to significant differences between the groups and data was sent to publication. All other patients were passively followed since April 2005 for cardiovascular events. We have decided to continue and follow these patients till end of December 2007 to determine the incidence of CVD in theses patients which are pre stratified by Haptoglobin Phenotype.

3054 diabetic patients from Clalit Medical Services were screened for Haptoglobin Phenotype as part of the ICARE study (NCT00220831) and composite the I CARE registry, 1434 Hp 2-2 patients were treated as part of the I CARE study with vitamin E vs. Placebo, this study was recently terminated due to significant differences between the groups and data was sent to publication.

During the follow up period of the I CARE study all 3054 registry patients were followed in a passive way, which means that the patients were not called for follow up visits but the reports for CVD events were centrally collected from patient's Hospital admission summaries. Admission summaries were collected using the computerized systems of the Clalit Health Services assuring that when ever a patient in the registry is hospitalized for what ever reason the study coordination them would be aware of that and receive the admission summary. An events adjudication committee adjudicated each event in a blinded fashion to determine the nature of the events.

1434 patients who were treated by vitamin E or placebo in the I CARE study were also followed by follow-up telephone calls.

once I CARE study was officially terminated we have decided to continue and follow the whole 3054 registry patients in the same manner to complete a nearly 3 year follow up to determine in a prospective manner the incidence of CVD events in Diabetic patients which were pre-stratified by Haptoglobin type.

Eligibility Criteria:
These are the same patients as in I CARE registry so the criteria are the same as was for I CARE study Recruitment phase.

Inclusion Criteria:

* Diabetic patients aged 55 and above

Exclusion Criteria:

* Patient who takes antioxidant treatment will be asked to stop, or can't be included in the study
* Patients who had a CVD incident (MI, Stroke, TIA), Unstable angina pectoris, Uncontrolled HTN, will have to wait a month after stabilization to be included in the study
* Allergy to Vitamin E
Social Media Intervention - Physical Activity

The purpose of the study is to develop and test social media interventions to help young people increase well-being and reduce risky behaviors. The study will help us learn about ways to deliver wellness information in a way that is appealing and helpful to young people that use social media.

Eligible participants will be enrolled after baseline survey is completed. Participants will be involved with the secret social media group they are assigned to for 8 weeks. In addition, surveys will be completed at various times during and after the 8 week social media group.


Eligibility Criteria:
Inclusion Criteria:

* self-report using cannabis at least 3 times per week or more often in the past month
* active Facebook profile

Exclusion Criteria:

* participants who cannot read English will be informally excluded
* if participants fail identity verification based on:

  * Internet Protocol (IP) addresses
  * survey time completion
  * repeat attempts
  * survey responses
  * photo identification from a time stamped self picture sent to the research team
* cannot safely engage in moderate to vigorous physical activity \[assessed at screening\]
* participated in previous Project Verdi waves
Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Cataract Surgery

To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after cataract surgery


Eligibility Criteria:
Inclusion Criteria:

1. age-related cataract
2. dry eye disease

Exclusion Criteria:

1. a history of surgery and other ocular diseases
2. contact lens use
3. ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months. had 4.any systemic diseases such as heart diseases, diabetes and psychosis.
Work of Breathing Assessment in Triage Scale

The proposed research study will be a prospective observational study designed to validate the Canadian Triage Assessment Scale (CTAS) in regard to work of breathing in patients in the emergency department. The investigators will assess inter-rater agreement between nurses \& emergency physicians for assessment of work of breathing.

Investigators will enroll a convenience sample of consenting patients who present to the emergency department with a chief complaint related to respiratory symptoms, including shortness of breath, cough, difficulty breathing, hypoxemia, or any other respiratory related complaint.

Following consent and in a blinded fashion, the nurse \& emergency physician will be asked to evaluate the patient's work of breathing into three subjective categories: mild, moderate, or severe. The two evaluators will not be aware of the others evaluation of the patient. Evaluators will also be asked to predict the patients likely need for intervention \& disposition.

Subsequently, investigators will perform a chart review to determine the patient's clinical interventions, outcomes, and dispositions, and evaluate the assessment of the patients work of breathing.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age of older
* Presenting to the emergency department with a chief complaint of any type of respiratory symptom.

Exclusion Criteria:

* Under 18 years of age
* Refusal to consent to study
* Incarcerated patients
* Pregnant patients
* Unable to complete survey due to clinical instability, severe pain, or disorientation determined by a study physician.
Elastography Interest in the Management of Thyroid Nodules

Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 years old
* Patient affiliated to social security or similarly regime
* Patients referred for fine needle aspiration or surgery with one or more thyroid nodules

Exclusion Criteria:

* Patients with too much thyroid nodules or topography too imprecise to allow unambiguous correlation between echo/elastography data and histology/cytology data
* Patients withan echography/elastography indications cons
* Pregnant women and lactating mothers
* Adult unable to express their consent
* Ward of court or under guardianship
* Person under legal protection
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
Performance of 177Lu-PSMA-I&T for RLT in mCRPC - Prospective Multicenter Swiss Registry Study

The goal of this observational study (multicenter, national registry-based) is to evaluate the performance of 177Lu-ITG-PSMA-1 (177Lu-PSMA-I\&T) as therapy in patients with metastatic castration resistent prostate cancer (mCRPC).

The main questions are whether the 177Lu-PSMA-I\&T is safe and if it works well to treat patients with progressive mCRPC. The data and information in the study are collected under standard medical therapy and follow-up, so called real-world conditions.

Participants will:

* undergo regular radioligand therapy (RLT) with 177Lu-PSMA-I\&T
* have clinical, laboratory and imaging follow-up according to the currently available recommendation for PSMA-RLT an in line with their medical needs.
* answer study related set of questionnaires

Prospective, multicenter Swiss registry study evaluating the performance of 177Lu-ITG-PSMA-1 (177Lu-PSMA-I\&T) as RLT in mCRPC.

Primary endpoint: Safety-

* frequency and severity of adverse events (measured according to CTCAE 5.0). Secondary endpoints: Efficacy
* biochemical response: best PSA response, PSA50 (\>50% decrease from baseline PSA level) and PSA response at 12 weeks

  * imaging response: Objective response rate evaluated on follow-up morphological imaging CT/MRI and/or on molecular imaging PSMA PET/CT
  * quality of life: evaluated with standardized questionnaires

Eligibility Criteria:
Inclusion Criteria:

* hormone-refractory and PSMA PET/CT-positive prostate tumors
* progressed after or are ineligible for chemotherapy, next-generation antihormonal therapy or bone-directed radiation therapy -- male patients with an age above 18 years

Exclusion Criteria:

* patients who are not eligible for PSMA RLT, according to current, standard medical indications and guidelines
* patients who for medical or non-medical reasons are unable to give their consent
* patients withdrawing their consent for participation (NB: the already collected data in such cases will be anonymized and further used for applicable analyses)
A Clinical Study of Systane® Lid Wipes in Brazil

The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.


Eligibility Criteria:
Inclusion Criteria:

* Must sign informed consent.
* Agree to adhere to the procedures and requirements of the study.
* Wears makeup daily.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Ocular conditions as specified in protocol.
* Medical conditions as specified in protocol.
* Skin conditions as specified in protocol.
* Other protocol-specified exclusion criteria may apply.