cyrilzakka/clinical-trials huggingface dataset:
Adapting Project UPLIFT for Hispanic Patients With Epilepsy II

The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression. Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL); it was developed at Emory University with CDC funding. The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression. Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL); it was developed at Emory University with CDC funding.

The goal of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression. A 2-arm randomized control trial will be conducted to evaluate the feasibility, acceptability and effects of Project UPLIFT versus usual care (UC) in Hispanic patients with epilepsy.

The specific aim of this study is: To evaluate the feasibility, acceptability and short- and long-term effects of the adapted intervention on depression and other outcomes in 72 English- and Spanish-speaking Hispanic epilepsy patients.

Eligibility Criteria:
Inclusion Criteria:

* self-identified as Hispanic
* English or Spanish speaking
* diagnosis of epilepsy for at least one year post diagnosis
* willing to participate in 8 one-hour telephone sessions every week for eight weeks.
* willing to be audio-taped
* Elevated depressive symptoms (Center for Epidemiological Studies Depression Scale (CES-D) score \>13

Exclusion Criteria:

* Severe depression (CES-D \> 37)
* Active suicidal ideation
* Significant cognitive impairment (evident during screening)
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)

The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the outcome of intensive language therapy in chronic aphasia.

Stroke is the leading cause of death and disability worldwide. Given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. One of the most frequent and devastating conditions after stroke is aphasia, which affects language production and comprehension. High-frequent intensive speech-and-language therapy is currently the treatment of choice in chronic aphasia. However, despite its general effectiveness, treatment effect sizes are only low to moderate. Thus, there is a pressing need to explore novel training-adjuvant therapies to enhance treatment efficacy. Moreover, very little is known about the neurobiology of treatment-induced recovery in chronic aphasia. This is the prerequisite to improve existing and/or develop new treatment paradigms.

Thus, in the present project the investigators aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. They will be using anodal transcranial direct current stimulation (atDCS) that has previously been shown to enhance (a) language and motor learning in healthy subjects and (b) motor recovery in stroke patients. Specifically, in a longitudinal group comparison design, two matched groups of patients with chronic anomia will receive two weeks of intensive language training with or without atDCS. Treatment effects will be assessed immediately after the two week intervention period and several months after the end of the training. The Investigators will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* chronic stroke (\> 1 year after event)
* aphasia due to stroke with naming impairment
* German as first language
* first-ever stroke

Exclusion Criteria:

* more than 1 stroke
* history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity
* dementia
* contraindications for Magnetic Resonance Imaging or transcranial direct current stimulation
Health Effects of Resistance Training on Postmenopausal Women

Today's women will live more than a third of their lives after menopause, i.e. with a changed hormonal and metabolic state. Vasomotor symptoms like hot flushes and sweating are reported by about 75% of all women around menopause and may impair well-being, mental state, daily activities and night sleep. Vasomotor symptoms are less prevalent in women who participate in regular physical exercise. It is, however, still uncertain if physical exercise reduces vasomotor symptoms.

The purpose of this randomized controlled study is to establish possible beneficial health effects from 15 weeks of supervised resistance training (RT) on postmenopausal women. End-points include effects from RT in postmenopausal women on

1. clinical outcomes (number and severity of vasomotor symptoms, Health-Related quality of Life (HRQoL), Body Mass Index (BMI), abdominal height, muscle strength and mass, browning of fat),
2. diagnostic variables (production of myokines as irisin, immunological markers) and
3. genetic variables (length of telomeres).

The control group will be offered resistance training after the intervention period.

The first phase is planned as a pilot-study including 20 women participating for 15 weeks. Thereafter an evaluation of the sample size and the study methodology will be made.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women who had at least 28 moderate to severe hot flashes per week during a screening period of two weeks.(Postmenopausal, i.e. had their last menstrual bleeding at least 12 months ago or have increased gonadotrophic hormones showing they are postmenopausal.)
* At lest 45 years of age
* Good physical health and physical ability to take part in organized resistance training or other training at least three times per week.
* Ability to speak and read Swedish
* Freely informed consent for participation

Exclusion Criteria:

* Physically active more than 75 minutes of intense exercise per week or more than 150 minutes of low intensity activities
* Hb \<110 g/l
* Blood pressure \>160 systolic and/or \>100 mmHg diastolic pressure
* Ongoing usage or use during the last two months of hormone therapy aimed for hot flashes
* Treatment with psychopharmacological drugs (e.g SSRI or SNRI) or other treatment with a possible effect on menopausal symptoms
* Uninvestigated or unstable disease that could affect presence of flushes (e.g thyroid disease)
* Other medical condition that is judged inappropriate to combine with physical activity or participation in the study.
Strengthening Physician Communication About HPV Vaccines

The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV) immunization program carried out in pediatric and family medicine practices would be more effective in improving adolescent patients' HPV immunization rates than the usual care provided to adolescents in pediatric and family medicine practices.


Eligibility Criteria:
Inclusion Criteria for immunization rate assessment:

1. 9 years of age or older when presenting for care
2. Patients who present for care one year prior to the start of the intervention and up to two years after the start of the intervention

Exclusion Criteria:

1. Less than 9 years of age when presenting for care
2. Patient is not eligible for HPV immunization

Provider survey:

Providers who are working at participating practices during the two times a cross-sectional survey is administered.

Parent survey:

Parents of adolescents who presented for care within one 1 year prior to the two times a cross-sectional survey is administration.
Ridge Preservation Using Different Techniques

Soft tissue contour and radiographic evaluation of alveolar ridge preservation using different techniques

Background:

Following tooth extraction, the alveolar ridge undergoes an inevitable remodeling process which influences future implant therapy or prosthetic rehabilitation in the edentulous area. In an attempt to attenuate the loss of hard and soft tissue after tooth loss, alveolar ridge preservation (ARP) immediately after complete tooth extraction could minimize the need for ancillary ridge augmentation or soft tissue grafting. Different techniques and barrier membranes has been proposed to achieve the sealing of extraction socket.

Aim:

To investigate the effect of different techniques and barrier membranes for the soft tissue contour and morphological change of alveolar ridge after ARP

Methods:

The study was designed as a randomized controlled trial and recruited patients, who require ARP for the purpose of implant placement or prosthodontic rehabilitation. After the tooth extraction, patients were randomly allocated to one of the following groups: ridge preservation with a xenogeneic bone substitute and (a) spontaneous healing (control), (b) covered with a free palatal graft, (c) or covered with pedical palatal graft, (d) covered with a collagen membrane, (e) covered with a non-resorbable high-density polytetrafluoroethylene membrane. 2 weeks, 4 weeks, 12 weeks, and 24 weeks following tooth extraction and ARP, clinical profilometric and radiographic evaluations were performed to analyze the change of hard and soft tissue contour. Moreover, and the need for additional guided bone regeneration (GBR) or soft tissue augmentation were assessed prior implants or fixed prosthesis placement.


Eligibility Criteria:
Inclusion Criteria:

* \>20 years old
* No contraindications for invasive dental procedures.
* Not pregnant.
* Teeth need to be extracted due to malocclusion or broken teeth.
* Requires dental implant or denture fabrication after tooth extraction.
* Healthy soft tissue (probing bleeding index \<20%, plaque index \<20%).
* At least 2mm of keratinized gingiva on the buccal and lingual sides.
* No need for simultaneous bone augmentation surgery during implant placement.
* Willing to participate in and sign the consent form for this trial.

Exclusion Criteria:

* Poor oral hygiene maintenance.
* Uncontrolled periodontal disease.
* Heavy smoker (smokes \>20 cigarettes per day).
* Uncontrolled diabetes.
* Alcohol abuse.
* Currently receiving medication treatment affecting wound healing (osteoporosis medication, radiation or chemotherapy).
Evaluation of a Functional Training Program in Primary Health Care

Sedentarism is the fourth risk factor for worldwide mortality and morbility. Considering the high prevalence of sedentarism (57.0%) and obesity (30.5%) in Azores islands (Portugal), local primary health care (PHC) services should support the implementation of complementary interventions and the development of medical research in the area of active lifestyle promotion.

This study aims to evaluate the feasibility and effectiveness of a 6-months functional training program (FTP), which includes a group nutrition counseling, in sedentary users of Ponta Delgada Health Center (PDHC), compared to a waiting list control.

This work will be a prospective, longitudinal, quasi-experimental study, with an experimental and a waiting list control group. Here, the investigators aim to test the feasibility and effectiveness of a 6-months functional training program in sedentary users of PDHC. The recruitment of participants will be held in PDHC by health professionals (e.g., family medicine doctors, nurses, nutritionists, psychologists, etc). Participants will be allocated into two groups (experimental and waiting list control groups). After signed informed consent and baseline measures, experimental group will conduct a 6-months functional training program (FTP), which comprises functional training sessions and group nutrition counseling. In every session, it will be evaluated the participants' adherence and theirs perceived enjoyment and exertion. The other outcomes (primary and secondary) will be analyzed through a face-to-face contact, in three different moments: baseline (T0), post-intervention (at month 6, T1) and 6-month follow-up (at month 12, T2). The control group will not participate in any specific intervention, but will receive the FTP after the experimental period. An intention-to-treat and per protocol analysis will be performed to analyze intervention effectiveness and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary (\<150 minutes of moderate-intensity PA per week or \<75 minutes of vigorous-intensity PA) users of Health Center of Ponta Delgada.

Exclusion Criteria:

* Users with a medical contraindications to moderate-to-vigorous intensity physical activity, such as: unstable angina; deep vein thrombosis; recent thromboembolism or embolism; acute systemic infection or fever; atrioventricular block of 2nd grade or higher (without pacemaker); negative deflection of the ST segment deflection of the ST segment \> 2 mm; severe neuro-musculoskeletal dysfunction; severe mitral or aortic insufficiency or stenosis without adequate treatment; decompensated heart failure; resting heart rate above 100 bpm; other decompensated metabolic disorders; pericarditis or acute myocarditis; uncontrolled arrhythmia; uncontrolled resting hypertension (SBP ≥ 180 or DBP ≥ 110); orthostatic hypotension with a fall in SBP\> 20 mmHg or uncontrolled diabetes.
* Users with physical and/or mental disabilities or
* Pregnant women.
Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19

Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19

This is a Phase 2, open-label, randomized 2-arm multicenter study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) administered orally plus Standard of Care (SOC) versus SOC in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 infection and COVID-19 pneumonia (documented radiographically). Only hospitalized patients are eligible for this study.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed infection with SARS-CoV-2 per World Health Organization (WHO) criteria (including positive RT-PCR nucleic acid test of any specimen \[eg, respiratory, blood, urine, stool, or other bodily fluid\]) within 7 days of randomization
* Hospitalized with COVID-19 pneumonia (documented radiographically) and oxygen saturation \<94% on room air or subject requires supplemental oxygen
* Able to swallow capsules
* Willing to follow contraception guidelines
* Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used

Exclusion Criteria:

* Known cardio-pulmonary resuscitation within 14 days prior to randomization
* Pregnant or breast feeding
* Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
* Alanine aminotransferase (ALT) ≥ 3x upper limit of normal (ULN) and total bilirubin \> 2x ULN
* QTcF prolongation \>480 milliseconds
* Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll
* Treatment with a strong cytochrome P450 (CYP3A4 inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug)
* Received anti-rejection or immunomodulatory drugs (eg, anti-cytokines, BTK inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
* Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
* Any condition that confounds the ability to interpret data from the study
* Relevant renal impairment (eGFR \<60 mL/min)
* Any significant medical condition, laboratory abnormality or psychiatric illness that would interfere or prevent the subject from participating in the study
The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of RIF

The investigators checked the hypothesis whether endometrial injury performed during the cycle before a frozen embryo transfer in women with RIF can improve pregnancy rates

After a freeze all cycle, participants were divided in two groups: an intervention group (n=30), who underwent endometrial injury before the transfer, and a control group (n=30), who underwent no other intervention. The primary outcome was clinical pregnancy rate, while secondary clinical and laboratory parameters. Baseline and cycle characteristics were also compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Women with RIF under 42 years old
* BMI 20-30
* Normal endometrial cavity
* FSH \<15 IU/L
* Absence of immunological or hematological disorder

Exclusion Criteria:

* women over 42 years old
* FSH\>15 IU/L
* women with chronic immunological or hematological disorder
* stage III or IV of endometriosis
* women with pathology concerning the endometrial cavity
* women with a medical history of adnexectomy or oophorectomy
Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection

This study is designed to investigate the acuity of olfactory dysfunction in COVID-19 positive patients in the United Kingdom. In particular defining severity with objective testing and determining if this has any predictive value on the outcome of the SARS CoV-2 infection. In addition, this study will strive to determine duration / natural history of olfactory dysfunction in these patients in respect to a positive SARS CoV-2 diagnosis. It should also demonstrate the impact of olfactory dysfunction on patient Quality of Life (QOL).

The main objective of this study is to evaluate olfactory acuity by means of a multidimensional assessment protocol to objectively demonstrate the severity of olfactory dysfunction in patients diagnosed with SARS CoV-2. The University of Pennsylvania Smell Identification Test (UPSIT) will be used to assess olfactory function in newly diagnosed patients and also existing patients longitudinally over a 12-month period. This is to document onset (where possible) and rate of progress of olfactory dysfunction.

In relevant cases, the investigators will correlate their findings with severity of the Acute Respiratory Distress Syndrome (ARDS) arising as a result of the infection - characterised as mild, moderate and severe according to the Berlin classification. The investigators will therefore determine if the degree of olfactory dysfunction correlates in any manner to the severity of ARDS developed in a positive SARS CoV-2 patient and if it offers any prognosticative applications.

The investigators will also examine the impact of the symptom of olfactory dysfunction on patient Quality of Life using two validated tools known as the Questionnaire of Olfactory Disorders for English speakers (eQOD) and the SNOT-22 questionnaire.

Furthermore, outcomes will be explored and stratified in terms of age, gender and ethnicity

Eligibility Criteria:
Inclusion Criteria:

* Patients who are presenting to hospital with symptoms of SARS CoV-2 infection.
* Patients who go on to develop a positive SARS CoV-2 test.
* Patients who can give a valid written informed consent.
* Patients who are motivated to participate in the study.
* Adult patients aged 18 years - 85 years.

Exclusion Criteria:

* Patients who cannot give a valid written informed consent.
* Patients who are not willing or not motivated to participate in the study.
* Patients with negative SARS CoV-2 tests.
* Patients with nasal pathologies like severe deviated nasal septum, nasal masses, head trauma or previously known chronic rhinosinusitis with polyps or on medication for more than 6 months/year for at least one year for chronic rhinosinusitis.
* Patients with any diagnosed neurological disease known to affect olfactory function will be excluded from the study.
* Patients unable to read in the English language.
Suicide Assessment and Feasible Evidence-based Treatments for Youth Living with HIV in Lilongwe

The overall aim of this study is to determine the feasibility, fidelity, acceptability, and preliminary effectiveness of the Friendship Bench +Safety Planning intervention in reducing suicidal ideation and behaviors (SIBs) and improving HIV engagement amongst adolescents living with HIV (ALWH) when compared to augmented usual care.

This project aims to evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the enhanced Friendship Bench+Safety Planning (FB+SP) intervention model. We will enroll 60 depressed ALWH who report suicidality from four facilities in Lilongwe, Malawi, and randomize them 1:1 to the enhanced FB+SP model or augmented usual care. This pilot trial is a step toward our long-term goal of generating and implementing an evidence-based model to prevent suicide in Malawi amongst ALWH by enhancing the capacity of the health system to identify suicidality and provide evidence-based care. Information gathered in this proposal will be used to develop a subsequent randomized control trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-19
* Diagnosed with HIV
* Report current or historical suicidal ideation and behaviors (SIBs) on question 9 of the Patient Health Questionnaire modified for adolescents (PHQ-9-A) and the Ask Suicide-Screening questionnaire (ASQ)
* Living in the clinic's catchment area with intention to remain for more than 1 year
* Willing to provide consent (age 18+ or 16-17 years old and married and thereby considered emancipated minors per Malawi law) or assent with parental consent (age 13-17).

Exclusion Criteria:

* Refuse to participate
* Refuse to be audio-taped for in-depth interviews