cyrilzakka/clinical-trials huggingface dataset:
Medication Adherence in Older People With Psychosis

This study will determine whether Medication Adherence Therapy (MAT) can improve medication adherence and lower the risk of rehospitalization in older patients with psychosis.

Psychoses are among the most common and serious psychiatric disorders. Currently, the most effective treatment for psychoses involves the use of antipsychotic or neuroleptic medications. Unfortunately, pharmacologic regimens often do not achieve their goals because of poor medication adherence. Nonadherence to antipsychotic treatment is a considerable public health problem that leads to myriad clinical and economic burdens, including psychotic relapse, increased clinic and emergency room visits, and rehospitalization.

Participants in this study are randomly assigned to receive either MAT or supportive treatment for 12 weeks. MAT is given in 15 sessions and consists of motivational interviewing, education, and social skills and behavior modification. Individual MAT sessions are held in Weeks 1 and 12; small group sessions take place in Weeks 2 through 11. Three monthly booster group sessions begin in Week 16. Participants are assessed at baseline and at 3, 6, and 12 months. Medication adherence, psychopathology, quality of life, medication side effects, health beliefs, and functioning are assessed.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for schizophrenia or schizoaffective disorder
* Outpatient status at the time of enrollment
* Currently prescribed maintenance treatment with antipsychotic medication (typical or atypical, oral or depot)
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed

In an effort to engage more HIV-infected PWUD into care, and ensure treatment adherence and efficacy, simplification of older, multi-tablet regimens is required. Newer, more potent molecules can also overcome resistant that has persisted with previous regimens, while simultaneously providing a high barrier to resistance. The co-formulation of B/F/TAF is a viable switch-option for patients who have experienced lower adherence with previous regimens due to high pill burden, or for those requiring a more potent regimen due to emergent resistances. The formal evaluation of B/F/TAF in this context will allow us to optimize care for HIV-infected PWUD.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is ≥19 years of age infected with HIV-1
2. Participant has an undetectable viral load \<40 copies/mL at screening with any CD4 count and has exhibited any, or all of the following:

   1. Transient HIV viremia (episodes of HIV viral load between 40-1000 copies/mL) in the past 12 months, OR Virologic breakthrough (HIV viral load \> 1000 copies/mL) in the past 12 months, OR Documented instances of non-adherence for a period of more than 7 days or...
   2. Participant is currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy)
   3. Participant has a history or current indication of illicit drug use.
   4. Patients infected with HCV and or HBV can be included in this study.
   5. If female, participant must have a negative pregnancy test and agree to use, for the duration of the study, a method of birth control that has a history of proven reliability as judged by the investigator.

Exclusion Criteria:

1. They have any documented history of integrase inhibitor resistance
2. They exhibit any of the following:

   1. Creatinine Clearance Rate \< 30 ml/min
   2. Hemoglobin \< 10.0 g/dL
   3. Absolute neutrophil count \<750 cells/mL
   4. Platelet count \< 50,000 /mL
   5. ALT or AST \>5x upper limit of normal (ULN)
   6. Creatinine \> 1.5x ULN
3. They are taking medication that is contraindicated with any component of B/F/TAF.
4. They are pregnant or breastfeeding.
5. They do not/have not ever used any form of illicit drug use.
CPG 7909 Injection in Melanoma

To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed melanoma that is metastatic.
* Measurable disease according to the RECIST criteria.
* Karnofsky Performance Status of \> 70.

Exclusion Criteria:

* Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy other than DTIC).
* Suspected or known CNS metastases.
Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women

Although there are many methods for the surgical treatment of pilonidal sinus disease, the number of studies specific to women is limited in the literature. In addition to post-treatment recurrence and complication rates in women, aesthetic results are also of great importance. This study will compare the Karydakis procedure, a flap method, and the Bascom's pit-pick procedure, a minimally invasive procedure, in terms of recurrence, complications and aesthetics, especially in female patients with three or fewer pits.

This study is a single-center, prospective observational trial aimed at comparing the effectiveness of the Karydakis flap and Bascom's pit-pick methods in treating pilonidal sinus disease in women. Female patients aged 18 and over, with three or fewer pits, will be included, and each patient will be followed for 12 months. The Bascom pit-pick method will be performed under local anesthesia, while the Karydakis method will be performed under spinal or general anesthesia. Postoperative recovery time, complications, recurrence rates, and patient satisfaction will be evaluated. Ethics committee approval has been obtained (Approval No: TE 172, Date: June 12, 2024).

Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years old and older
* Diagnosed with pilonidal sinus disease, having 3 or fewer pits.
* No previous surgical treatment for pilonidal sinus.

Exclusion Criteria:

* Under 18 years of age
* Pregnancy
* Presented with acute abscesses
* Patients with recurrent disease, Stage-R.
* \>3 pit
* Collagen tissue disease
* Exceed to navicular area
* Lateral extension in both directions
* Accidentally discovered (asymptomatic) sinus or with follow-up \<12 months
The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease

There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces the amount of fat stored in the liver and improves liver function. The purpose of this study is to see whether this observation is correct.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of non-alcoholic fatty liver disease
* fatty infiltration on ultrasound
* abnormal serum liver function tests.

Exclusion Criteria:

* any other identified cause of chronic liver disease
* the prescription of medication which would cause non-alcoholic fatty liver - disease (e.g. tamoxifen)
* already taking supplementary fish oil
* alcohol intake of \>20g/day for women, \>40g/ day for men
* known allergy to fish oil
* on anticoagulants (antiplatelets are permitted)
* severe heart failure (NYHA class IV)
* pregnancy/ lactation
* age under 18 years.
Identifying Genes That May Increase the Risk for Heart Disease in African Americans

Heart disease and stroke disproportionately affect African Americans in the United States. These conditions are likely caused by both environmental and genetic factors. This study will attempt to identify specific genes of African and European ancestral origins that may influence the development of heart disease in African Americans.

African Americans have a high risk of developing heart disease and stroke, and are more likely to die from heart-related illnesses than other racial and ethnic groups. A large majority of African Americans are descendants of both African and European ancestors who mixed five to six generations ago. Because only a few generations have passed since that time, it is still possible to identify specific genes, the basic units of heredity, as being either African or European in origin. This is a sub study of the Jackson Heart Study, which is examining the environmental and genetic factors that influence the development of heart disease in African Americans. In this study, researchers will examine genes from participants in the Jackson Heart Study to identify specific African and European genes that influence the development of heart disease in African American men and women.

This study will use genetic samples from individuals participating in the Jackson Heart Study. There will be no study visits for participants. Study researchers will examine the genetic samples and identify specific African and European genes that may influence the development of heart disease, high blood pressure, lipid disorders, left ventricular hypertrophy, and low birth weight.

Eligibility Criteria:
Inclusion Criteria:

* Unrelated African Americans living in Hinds, Rankin, or Madison County, Mississippi enrolled in the Jackson Heart Study
Regulation of Inflammatory Genes in Hidradenitis Suppurativa

The purpose of this protocol is to examine the cytokine profi le of pati ents with hidradeniti s suppurati va (HS) and idemechanisms responsible for post-transcripti onal regulati on of these genes. The primary objecti ve is to determinfollowing cytokines linked to hidradeniti s suppurati va are diff erenti ally expressed in hidradeniti s pati ents versus controlalso doing a sub-study to determine the eff ect of childhood trauma on HS. The parti cipati on in the sub-study is opti onal

Hidradeniti s suppurati va (HS) is a chronic infl ammatory cutaneous disease which involves the pilosebaceous-apocrwhich typically presents aft er puberty with painful nodules and abscesses which can form sinus tracts and scars in theapocrine gland-bearing sites of the body. 1 Esti mates of disease prevalence range from 0.0003% to 4%, with youngparti cularly women as the most eff ected group. Racial predilecti on has also been demonstrated, with a higher likeldisease in African American and biracial individuals when compared to whites.1 HS is an under-recognized enti ty, ontaking 7.2 years from symptom onset to formal diagnosis.2 A notable aspect of HS is the profound impact it can have oof life in pati ent's suff ering with the disease, with an increase in depression, pain, and social and work impairment.pathogenesis conti nues to be elucidated but is primarily thought to be due to follicular hyperkeratosis, leading formati on, dilati on, and rupture. This in turn causes infl ammati on, abscess and sinus tract formati on. 1, 4 Whiunderstanding of a role of tumor necrosis factor (TNF) alpha, interleukin (IL)-1, IL-17A, IL-23, C-reacti ve protein (Cinterferon (IFN) gamma have been previously shown, much is sti ll unknown of the molecular involvement of infl ammarkers in HS.1, 2, 4. Currently, management varies from topical treatment, to surgical excision, to prescribing manbiologic medicati ons used for hidradeniti s suppurati va and infl ammatory bowel disease. However, there can be vasvariability in response to these medicati ons, and a proper understanding of the infl ammatory markers involved inpathogenesis will allow for more specifi c treatment, while hopefully avoiding the adverse eff ects related to these isuppressive medicati ons. Thus, in this study we will assess the cytokines, TNF-alpha, IFN-gamma, IFN-alpha, IFN-beta, IIL-12, IL-23, IL-17A, and study their regulati on in HS lesions of pati ents, with the ulti mate goal of identi fying potenti al tafuture therapies and interventi ons.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with hidradenitis suppurativa
* Not Pregnant

Exclusion Criteria:

* Mild/general dermatological issues like moles, other cosmetic issues
* Patients with hidradenitis suppurativa, psoriasis, roasacea, atopic dermatitis and other inflammatory skin disease
* Pregnant
Study to Investigate the Pharmacokinetics and Safety of Cadazolid in Patients With Clostridium Difficile Infection

The study investigated the pharmacokinetics, safety, and tolerability of cadazolid in subjects with severe Clostridium difficile diarrhea (CDAD) and whether this influenced the quantity of cadazolid absorbed into the systemic circulation.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Non-pregnant females were to remain non-pregnant for 1 month after the end of the study. Female subjects of child-bearing potential must have had a negative serum pregnancy test at screening and must have used a reliable method of contraception
* Subjects with severe CDAD; Clostridium difficile infection (CDI) must have been microbiologically proven, using a validated enzyme-linked immunosorbent assay (ELISA) for the detection of C. difficile toxin A (TcdA) and/or C. difficile toxin B (TcdB). The severity of CDAD was assessed according to the current European Union guidelines - European Society of Clinical Microbiology and Infectious Diseases (ESCMID).
* Received oral vancomycin or oral/intravenous (i.v.) metronidazole therapy for the treatment of CDAD.
* Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

* Known hypersensitivity to any excipients of the drug formulation.
* Clinical evidence of any relevant disease other than CDAD and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study drug.
* Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).
* Subjects with rare hereditary fructose intolerance, glucose-galactose malabsorption, saccharase-isomaltase deficiency or previously undiagnosed diabetes mellitus.
* Subjects who have a life-threatening condition, which may be related to CDAD or other underlying illness.
* Any clinically relevant electrocardiogram (ECG) abnormality at screening.
* Subjects who were unable to swallow or have difficulty swallowing.
* Subjects with vomiting, ileus or not passing stool.
* Likelihood of death within 72 hours from any cause.
* Life-threatening or fulminant CDAD (White blood cell count \> 30 × 10\^9/L; temperature \> 40 °C; or septic shock, peritoneal signs or significant dehydration).
* History of ulcerative colitis or Crohn's disease.
* Loss of 250 mL or more of blood within 3 months prior to screening.
* Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
* Positive results from the human immunodeficiency virus (HIV) serology at screening.
* Legal incapacity or limited legal capacity at screening.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study

Foot complications are a common and costly problem for subjects with diabetes. Although Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not wear their diabetic shoes in and around their house. Instead, subjects may wear shoes, such as flip flops or slippers, that provide little to no protection against injuries. While proper house shoe is important in the prevention of diabetic foot complications, this area has not received much attention. The purpose of this pilot study is to assess if CrocsRx Medical silver cloud clogs - a lightweight clog with protective toe box, cushioning soles, and easy to don and doff - offer reduced dynamic plantar pressure magnitude, as compared to conventional house shoes, for subjects with diabetes. A Repeated Measures ANOVA study design will be used to assess dynamic plantar pressure in 2 shod conditions for each subject with the order of shoes randomized.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 21 and 75 (inclusive)
* Documented type 1 or type 2 diabetes mellitus
* Demonstrated abnormal foot biomechanics by the presence of intractable plantar keratoma (IPK) beneath metatarsal heads or hallux
* Participants with and without signs of peripheral neuropathy (unable to perceive a 10 gram monofilament or vibration perception threshold (VPT \> 25 Volts)
* Able to walk independently without the use of walking aids (cane, crutches, or walker)
* Able to speak and understand English
* Able to understand the information in the consent form and willing and able to sign the consent form

Exclusion Criteria:

* History of lower limb amputations (excluding toe amputations)
* Presence of cutaneous ulceration in the lower extremity
* History of or active Charcot neuroarthropathy of either foot
* Severe peripheral vascular disease (i.e. ischemic rest pain, 2-block claudication, or gangrene)
* End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease
* Pregnant or nursing
* Not willing or able to make the required follow-up visits
* Insufficient (corrected) vision to complete the questionnaire
* Unable to fit into available shoe sizes
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis

The purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Enthesitis Related Arthritis (ERA) as defined by International League of Associations for Rheumatology (ILAR);
* Disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location;
* Inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate.

Exclusion Criteria:

* Any ILAR Juvenile Idiopathic Arthritis (JIA) subtype other than ERA;
* Psoriasis or a history of psoriasis in the patient or first-degree relative;
* Presence of Immunoglobulin M (IgM) rheumatoid factor;
* Presence of systemic JIA;
* History of inflammatory bowel disease;
* previous biologic therapy including anti-tumor necrosis factor (anti-TNF) therapy with a potential impact on pediatric ERA;
* Infection(s) requiring treatment with IV anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline.
Electrical Brain Stimulation for Treatment of Secondary Symptoms in Multiple Sclerosis

Multiple Sclerosis (MS) is an autoimmune disease associated with physical disability, psychological impairment, and cognitive dysfunction. As a result, the disease burden is high, and treatment options are limited. In this randomized, double-blind study, the investigators planned to use repeated electrical stimulation and assess mental health-related variables (e.g., quality of life, sleep, psychological distress) and cognitive dysfunction in patients with MS.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of MS according to the diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria (Polman et al., 2011), certified by a professional neurologist
2. being 25-55 years old
3. providing written informed consent
4. If female, a negative urine pregnancy test
5. stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment
6. right handed

Exclusion Criteria:

1. smoker
2. pregnancy
3. alcohol or substance dependence
4. history of seizure
5. history of other neurological disorders than MS
6. history of head injury
7. presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces.
"CHOiCE"! Choose Health: Oncological Patients Cenetered Exercise

The "CHOICE!" study is an exercise program following the recommendation of the American College of Sports Science for cancer patients. The aims of the intervention are to test the safety and feasibility of a structured program, letting patients choose the modality of delivery. Secondary endpoints include exercise health-related skills and quality of life. The program considers the preferences of exercise of cancer survivors, giving the possibility to choose the exercise modality (autonomous, with a personal trainer or group class). This program will be tested in different cancer populations with different study designs based on different patients cohort (i.e., RCT or single-arm).


Eligibility Criteria:
Inclusion Criteria:

* a confirmed cancer diagnosis;
* ≥ 8 weeks post-surgical procedure;
* Medical clearance for participation provided by primary care physician or oncologist;
* Informed consent signed;

Exclusion Criteria:

* Age \< 18 years old;
* Pregnancy;
* Inability to ambulate;
* Contraindication to participation in a regular physical activity program;
* Inability to understand the instructions for PA and/or Mini Mental State index \<24;
* Serious physical limitation and/or Karnofsky index \<50.
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:

the study aims to evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing abdominal myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects.

The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:

* Arm 1: intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
* Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
* Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets(placebo).

Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computer-generated randomization table with a 1:1:1 group allocation

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 16-45 years
2. Appropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm)
3. Baseline hemoglobin ≥9 g/dl
4. No contra-indications to the use of glyopressin or carbitocin
5. Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility
6. Not pregnant at the time of presentation

Exclusion Criteria:

1. Previous myomectomy
2. History of bleeding disorders
3. Concurrent anticoagulation therapy
4. History of Uncontrolled ischaemic heart disease
5. Any pelvic abnormalities requiring concomitant surgery
6. Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
7. Inability to understand and provide written informed consent.