cyrilzakka/clinical-trials huggingface dataset:
NSAIDs in Coronary Artery Disease Patients

Introduction:

Different groups already showed in retrospective subgroup analyses, that there is an increased risk for cardiovascular events in patients on a simultaneous ASA/NSAID treatment.

Methods:

Light-Transmission aggregometry

Hypothesis:

Simultaneous administration of different NSAIDs and ASA impair the platelet inhibiting effect of ASA.


Eligibility Criteria:
Inclusion Criteria:

* Patients on a simultaneous ASA, NSAID treatment
* \> 18 years

Exclusion Criteria:

* unconsciousness, not able to consent
* reanimation, cardiac shock
Executive Training and Anomia Therapy in Chronic Post-stroke Aphasia

Aphasia is a devastating acquired language impairment mainly caused by stroke, in which anomia is a quintessential clinical feature. If speech-language therapy (SLT) has been shown to be effective for persons with aphasia, the relative efficiency of one SLT strategy over another remains a matter of debate. The influential relationship between language, executive functions and aphasia rehabilitation outcomes has been addressed in a number of studies, but only few of them have studied the effect of adding an executive training to linguistic therapies.The aim of this study is to measure the efficiency of a protocol combining anomia therapy and executive training on naming skills and discourse in post-stroke aphasic persons at the chronic stage


Eligibility Criteria:
Inclusion criteria:

* 18 \< age \> 80 years
* adult person with chronic post-stroke aphasia (\> 6 months postonset)
* receiving SLT rehabilitation 3 times a Week

Exclusion criteria:

* presence of apraxia of speech
* major impairment of comprehension
* history of other neurological or psychiatric disease

Exclusion criteria:

* presence of apraxia of speech
* presence of major impairment of comprehension
* presence of history of other neurological or psychiatric disease
Conventional SILS vs Harmonic Scalpel SILS

Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are some obstacles making this procedure more complex than conventional laparoscopic cholecystectomy. The use of harmonic scalpel may aid in solving some of these issues that may allow simplification of the technique. The investigators will compare the ordinary method of single incision laparoscopic cholecystectomy versus harmonic scalpel single incision laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic gallbladder stones

Exclusion Criteria:

* acute cholecystitis cbd stones contraindications for laparoscopy
WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS

The purpose of this study is to determine whether weekly text-messages improve retention in care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).

Patient retention in care is critical to the success of programs funded by the President's Emergency Relief Plan for HIV/AIDS (PEPFAR). High levels of patient retention after first clinical contact contribute to the timely initiation of antiretroviral therapy (ART) and better health outcomes for patients. With the dramatic proliferation of cell phone use in Africa, telecommunications technology offers new opportunities to improve retention using a low-cost, culturally appropriate format. In Kenya (WelTel Kenya1), a weekly short message service (SMS) text message led to improved ART adherence and viral load suppression. This study, WelTel Retain, will evaluate the effect of WelTel on retaining pre-ART patients in care and determine the cost-effectiveness of the intervention. Specific objectives include: 1) determining if the WelTel SMS intervention improves patient retention in the first stage of HIV care; 2) determining whether the WelTel SMS intervention improves 12-month retention; and 3) evaluating the cost-effectiveness of the WelTel SMS intervention. We will fulfil these objectives by conducting a randomized controlled trial at the Kibera Community Health Centre in Nairobi, Kenya. Over one year, HIV positive individuals newly enrolling at the clinic will be recruited and randomly allocated to an intervention or control arm at a 1:1 ratio. Intervention arm participants will receive a weekly SMS 'check-in' to which they will be required to respond within 48 hours. An HIV clinician will follow-up and triage any problems that are identified. The control arm will receive standard of care. Patients will be followed for one year. The WelTel Retain study will contribute critical information on the effectiveness of an mHealth program to engage patients in care during the first year of HIV care. This research has the potential to demonstrate that the WelTel SMS intervention is an effective, feasible retention strategy, which can contribute significantly to the long-term success of PEPFAR-funded programs and towards a sustainable global HIV/AIDS response.

Eligibility Criteria:
Inclusion Criteria:

* evidence of HIV infection
* newly enrolling at the Kibera Community Health Centre
* own or have sufficient access to a cell phone; able to operate a cell phone using simple text-messaging\*
* able and willing to provide informed assent/consent to participate \*If a participant does not own a phone but has sufficient access to a cell phone (through a partner, relative, etc.), the participant would be able to either 1) use the accessed phone to respond to the text messages themselves; or, if they are unable to text themselves 2) have their partner, relative etc. respond on their behalf.

Exclusion Criteria:

* individuals will be excluded if they do not meet all of the inclusion criteria.
* individuals transferring from other clinics who are already taking ART will also be excluded.
Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.

Pudendal nerve release surgery in case of pudendal impingement syndrome is well described in literature.Pudendal nerve modulation in case of chronic perineal pain is also a promising technique and some small studies exist. However, in the latter group, patient inclusion criteria are very heterogenous and so conclusions about efficacy are difficult to draw. In the surgery group, outcome results also vary between the different approaches but in general, there is room for improvement. After pudendal nerve release in chronic perineal pain syndrome, it can take up to 6 months before improvement for the patient is recorded. This is partially due to the complex chronic pain syndrome mechanism.

Nothing is known about the possible effect of early neuromodulation at the level of the pudendal nerve after his release.

Recently, two cadaveric studies were published which described a minimal invasive trans gluteal approach for pudendal nerve decompression and a pudendal electrode placement.

In the present trial, the investigators would like to combine the endoscopic trans gluteal pudendal release with pudendal neuromodulation to improve the outcome for patients suffering from pudendal impingement syndrome.

The aim is to improve the results of pain score and quality of life of patients undergoing surgery for pudendal release in case of chronic perineal pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Candidates for release surgery
* Patients meeting the five Nantes criteria
* Chronic pain for more than 3 months

Exclusion Criteria:

* Pregnancy
* Progressive neurological disease
Metabolism and Bariatric Surgery Study

The purpose of this study is to determine if diet-induced weight loss causes different changes in hormones that control appetite and glucose control than surgery-induced weight loss. The overall research plan is a non-randomized prospective study of 3 different weight loss (WL) interventions and a lean and an obese healthy control group.

Weight loss (WL) improves obesity-related co-morbidities such as type 2 diabetes mellitus (DM). Unfortunately, WL through life-style interventions has a high degree of relapse and the lack of safe, effective and affordable therapies together with an increase in the prevalence of morbid obesity has led to a rise in bariatric procedures. Clinical trials in patients with DM show that improvements in glycemia vary between procedures and occur in the following order: Roux-en-Y gastric bypass (RYGB) \> sleeve gastrectomy (SG) \> laparoscopic adjustable gastric banding (LAGB) \> medical/life-style therapy. This order mirrors the amount of WL with each intervention and is a major driver of glycemic improvement. The investigators have shown profound changes unique to RYGB and SG in levels of hormones that make up the "gut-brain" and "enteroinsular" axes. The association of some of these hormones with insulin sensitivity (IS) and glycemia, independent of WL strongly suggests that glycemic improvements after surgery occur in part through pathways that are distinct from just calorie restriction. This study builds on results showing that levels of fibroblast growth factor 19 (FGF19), a protein secreted by intestinal cells, are increased after RYGB and SG but not after low calorie diet (LCD). This difference may affect hormones that control the stress response to weight loss. The investigators will explore differences in hormones of the gut that affect appetite, body weight, and stress response in healthy lean and obese individuals. Obese individuals will also be studied before and after 15% body weight loss induced by LCD, RYGB or SG, and again at 1 year after study enrollment.

Eligibility Criteria:
Inclusion Criteria:

Men and women Ages 18-65 Years Old

Exclusion Criteria:

1. Altered Sleep-wake Cycle
2. Type 1 or 2 Diabetes
3. Previous Bariatric Surgery
4. Lactose Intolerance
5. Any Special Diet restrictions.
6. Use of medications that may affect body weight at screening or during a 3-month period prior.
7. Untreated thyroid disease
8. Other medical conditions like Cushing's, acromegaly, Hearth failure, Crohn's disease, etc.
9. Pregnancy
10. Tobacco or opioid use
11. Alcohol dependence
12. \> 3% weight change over the 3month period prior to screening
13. Unwillingness to maintain current level of physical activity over duration of study period
Somatoform Disorder in British South Asians

The study uses in depth interviews to understand their experience of somatoform disorder, possible explanations and their experience of somatoform disorder, possible explanations and their understanding of treatments, especially their ideas about psychosocial treatments.

"Somatoform" or "functional" syndromes are those that present with physical symptoms, not explained by well-recognized medical illness. Such symptoms are common in all settings and studies have reported that they accounted for one-fifth of all new presentations in primary care. Literature suggests that they are associated with significant levels of psychological distress, disability, impairments in quality of life and high levels of healthcare utilization. Research also suggests that medically unexplained symptoms cause similar (or higher) levels of disability than medically explained symptoms in primary care settings. There have been a number of studies that have looked at the cognitive and behavioural basis of somatisation, and treatment strategies have been trialed based upon a cognitive behavior therapy (CBT)-led approach for these patients.

In British South Asian patients the difficulties in managing this condition are further compounded as culture can have an important role in shaping the experience, interpretation \& clinical presentation of emotional distress. Patel reported that GPs found it very challenging to manage South Asian patients with chronic pain due to the way they present with pain, and a greater likelihood of psychosomatic presentations. Language differences as well as cultural differences contributed to the challenges, especially among first- generation South Asians. Further, they felt that self-management strategies were difficult to address. The author concludes by saying 'cultural influences play an important role in the consultation process where patients' behaviour is often bound in their cultural view of health care. (South Asian) patients' presentation of their condition makes diagnosis difficult but can also lead to miscommunication'.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of self-ascribed British South Asian origin.
* Over the age of 18 years.
* Able to understand spoken and written English and/or Urdu, Gujarati.
* Able to provide written informed consent.
* Registered with the GP practice.
* criteria for somatoform disorder (determined by PHQ15).

Exclusion Criteria:

* individuals with diagnosed physical or learning disability
* any form of psychosis.
Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting

The authors hypothesize that a pelvic kinematic disorder, demonstrated by a significant decrease in sacral slope, is associated with the risk of instability of total hip prosthesis, the sacral slope being measured by an EOS imaging system during the transition to sitting in unstable patients versus patients with no history of instability.


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 must be at least 18 years old and less than 85 years old
* Patient has a conventional first intention total hip arthroplasty (not dual mobility) by posterior approach
* "Case" patients have at least one previous episode of prosthetic dislocation repaired with surgery
* "Control" patients have no previous episode of prosthetic dislocation with more than 2 year since initial intervention

Exclusion Criteria:

* The subject is participating in a category 1 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 patient is under safeguard of justice or state guardianship
* Patient is pregnant, parturient or breastfeeding
* Patient with lumbar instrumentation
* Patient with severe dementia (Mini Mental State Examination \< 10)
* Patient with American Society of Anesthesiologists score ≥ 4
* Patient experience multiple falls
* Patient requiring early revision surgery (\<15 days postoperatively
* Patient with obvious implant positioning error on an X-ray of the pelvis.
* Patient with dislocation of traumatic origin (significant kinetic trauma)
Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes

Health care system (HCS)-based interventions have been limited by their inattention to social and environmental barriers that impede improvement in obesity-related behaviors. Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the organizational structure to provide longitudinal care for children with chronic illnesses, the clinicians to manage and support patients with chronic illnesses outside of clinic, and/or the health information systems that support the use of evidence-based practices at the point-of-care. Thus, the research question this study is designed to address is whether a novel approach to care delivery that leverages delivery system and community resources and addresses socio-contextual factors will improve family-centered childhood obesity outcomes.

The primary specific aims are to examine the extent to which the intervention, compared to the control condition, results in:

1. A smaller age-associated increase in BMI over a 12-month period.
2. Improved parental and child ratings of pediatric health-related quality of life.

The secondary aims are:

1. To examine parental ratings of quality and family-centeredness of pediatric obesity care and compare outcomes among participants in the intervention with the control condition
2. To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition
3. To assess the following process measures:

   * Reach
   * Extent of implementation
   * Fidelity to protocol
   * Parent satisfaction
4. To examine the extent to which neighborhood environments modify observed intervention effects
5. To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records


Eligibility Criteria:
Inclusion Criteria:

* child is age 2.0 through 12.9 years at baseline primary care visit,
* child's BMI is equal to or exceeds the 85th percentile for age and sex at baseline primary care visit,
* at least 1 parent has an active email address,
* at least one parent is comfortable reading and speaking in English.

Exclusion Criteria:

* children who do not have at least one parent/legal guardian who is able to follow study procedures for 1 year,
* families who plan to leave HVMA within the study time frame,
* families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties,
* children who have a sibling already enrolled in the study,
* children with chronic conditions that substantially interfere with growth or physical activity participation.
DNA Changes in Patients With Prostate Cancer

RATIONALE: Collecting and storing samples of blood from patients and their brothers with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers with prostate cancer.

OBJECTIVES:

* Determine the frequency of single nucleotide polymorphism (SNP) genotypes in patients with prostate cancer, their affected siblings, and an unaffected healthy population (control).
* Determine the age of onset of prostate cancer in affected probands and affected siblings.
* Determine the penetrance or likelihood that given SNPs will result in disease in affected siblings based upon Mendelian genetics.
* Determine the odds ratio of developing prostate cancer in the presence of SNPs.
* Determine SNP genotypes in patients enrolled on ECOG-E3805, a prostate phase III study enrolling men with D2 prostate cancer treated with androgen-ablation therapy alone or androgen-ablation therapy with chemotherapy, and correlate them with disease progression (i.e., androgen independence).

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to ethnicity, age at diagnosis, and Gleason score.

Patients, their affected siblings, and healthy participants (controls) undergo collection of blood samples. Genomic DNA is extracted from whole blood and sequenced for single nucleotide polymorphisms (SNPs) in Akt and mdm-2 genes. SNP data is correlated with clinical and biographical data.

PROJECTED ACCRUAL: A total of 500 patients (250 probands and 250 siblings) and 146 healthy participants (controls) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * Patient or sibling diagnosed with prostate cancer
  * Cancer-free participant (healthy control)
* Whole blood sample available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Role of Transcranial Direct Current Stimulation (tDCS) in Patients With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment attention deficit hyperactivity disorder (ADHD).

Randomized, double-blind Controlled Clinical Trial

Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria and who agree to participate in the study Will recruit from advertisements and clinical referrals to a PRODAH

Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is applied for 20 min

Sham tDCS Same assembly is used Current is applied for 30 sec

Both groups 5 stimulation sessions on consecutive days

Following tools at Baseline, 1st week, 2 st week, 3st week and 4st week Adult ADHD Self-Report Scale (ASRS) SDS - Sheehan Disability Scale CGI - Clinical Global Impression

Randomized, double-blind Controlled Clinical Trial

Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria and who agree to participate in the study Will recruit from advertisements and clinical referrals to a PRODAH

Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is applied for 20 min

Sham tDCS Same assembly is used Current is applied for 30 sec

Both groups 5 stimulation sessions on consecutive days

Following tools at Baseline, 1st week, 2 st week, 3st week and 4st week Adult ADHD Self-Report Scale (ASRS) SDS - Sheehan Disability Scale CGI - Clinical Global Impression

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 45 years
* Established diagnosis of ADHD according to DSM V through clinical interview and diagnostic criteria applied by trained physicians.
* ASRS greater than 21 in Part A or B
* Consent form signed
* Ability to read and interpret the self-applicable scales

Exclusion Criteria:

* Medication change in the last month
* The following comorbidities:

  1. Depressive episode with BDI greater than 9
  2. Anxiety Disorder with greater than 15 BAI
  3. Bipolar Disorder with depressive symptoms, manic or hypomanic in the last 6 months
  4. Schizophrenia and other psychotic disorders
  5. Autism
  6. dependence of substances
  7. Mental retardation or dementia
* Epilepsy or anticonvulsant use
* Clinically significant medical condition
* Contraindications for tDCS (metallic implants, cranioencefálica important anatomical change ...)

Exclusion criteria retrospectively: two fouls in a row dating to stimulation or three fouls in total days.
Physical Activity in Hidradenitis Suppurativa (HS)

The purpose of the study is to characterize the challenges to physical activity and exercise for HS patients and design an exercise program (EP) with evidence-based techniques and examine its outcome.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years old to 80 years old
* Have diagnosis of HS confirmed by a dermatologist
* Able to provide informed consent
* For the extended portion of the study: Classified as having moderate-to-severe HS as per the IHS-4 criteria

Exclusion Criteria:

* Individuals who are not yet adults
* Women known to be pregnant
* Prisoners
* Subjects, who in the opinion of the PI, cannot comply with the study procedures