cyrilzakka/clinical-trials huggingface dataset:
Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid

Patients with kidney failure on hemodialysis have an extremely high rate of cardiovascular disease including atherosclerotic cardiovascular disease. This, at least in part, is due to the chronic inflammatory status usually seen in these patients. Here we try to see if treatment with extended release nicotinic acid (Niaspan) can reduce their overall inflammatory burden (in general) and the atherosclerotic plaque inflammation (in particular).


Eligibility Criteria:
Inclusion Criteria:

* A signed consent form;
* Male or Female, 18 years or older;
* Diagnosed with ESRD, on maintenance hemodialysis for at least six (6) months;
* Subject must be able to understand and provide informed consent;
* No known contraindications to therapy with nicotinic acid;
* Female subjects of childbearing potential must be willing to be on an acceptable form of birth control for the duration of the study and for two month after they have stopped taking the study drug.

Exclusion Criteria:

* Any patient with a medical condition or taking any medications that would be contraindicated with the use of extended release niacin, such as active peptic ulcer disease;
* History of severe allergic reactions to the study medication;
* History of active infection or acute gouty attack within 2 weeks prior to enrollment;
* Known serological positivity for HIV, HBsAg, or HCV Ab;
* HbA1C \> 9;
* Total CK of more than three times of the upper limit of normal;
* Elevation of liver function tests at time of entry (AST and/or ALT \> 2 times the upper limit of normal);
* History of drug, alcohol, or chemical abuse within 6 months prior to enrollment;
* History of malignancy except adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin;
* History of an inflammatory disease such as SLE, rheumatoid arthritis or ulcerative colitis;
* Patients currently on pharmacological doses of nicotinic acid;
* Patients receiving chronic anti-inflammatory therapy;
* Patients with average baseline hs-CRP levels of \> 20 mg/L or \< 1 mg/L;
* Patients in whom FDG-PET/CT dual scans are contraindicated (e.g., pregnant patients or those with severe allergy to IV contrast; a pregnancy test will be performed in each female subject between 18 and 45 years of age prior to each scan)
Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)

Chronic Exertional Compartment Syndrome (CECS) in the lower leg is a debilitating condition in highly active individuals. Pain occurs in 1 or several leg compartments upon an exertional activity, typically running, that quickly dissipates once the activity stopped. Surgical fasciotomy is the standard for treating lower leg CECS, but success is variable. Complications may occur post-surgery and there is a potential for a repeat procedure. Recovery times post-surgery also vary greatly. Conservative treatments, such as gait retraining and botulinum toxin injections, are emerging as non-surgical options for the treatment of CECS with success through published case reports and case series. This study aims to evaluate the use of these non-surgical treatment options for CECS in the anterior and lateral leg compartments with a follow up for at least 2 years across multiple study sites.


Eligibility Criteria:
Inclusion Criteria:

* Active duty service
* Fluent in speaking and reading English
* Unable to run 2 miles without producing pain and/or symptoms
* Difficulty completing the running portion of their service-specific physical training due to pain and/or symptoms in their lower leg
* Meets clinical diagnostic criteria for CECS of the anterior or lateral compartment per clinical examination (palpation, intramuscular compartment pressure, lower leg MRI).

Exclusion Criteria:

* Prior botulinum injection in the lower leg compartment of the affected limb
* Prior compartment release of affected lower leg
* Recent (within the last 6 months) lower limb injury that needed medical intervention
* Completed formal gait retraining within the last 6 months
* Allergic to botulinum toxin
* Pregnant or breastfeeding
* Medical examination that indicates a condition other than CECS
Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) in Social Anxiety Disorder

This RCT examines the effectiveness of Attention Bias Modification Treatment (ABMT) as an augment to Cognitive-Behavioral Group Treatment (CBGT) for Social Anxiety Disorder (SAD) in adults. It is expected that ABMT vs. control training condition would achieve better therapeutic outcomes as indicated reduction in symptoms.

Participants from three groups (estimated 40 patients) will be offered to participate in the study

Outpatients seeking treatment for Social Anxiety Disorder (SAD) at Geha anxiety-disorders clinic will be randomized into two groups (ABMT+CBGT; placebo control+CBGT). One group will undergo an Attention Bias Modification Treatment (ABMT) aimed at diverting attention away from socially-threatening stimuli. The second group will receive a placebo-control not designed to affect attention. Both groups will also undergo a standard Cognitive-Behavioral Group Treatment (CBGT) comprising 18 weekly sessions of 1.5-hr duration (along the lines of Heimberg, Juster, Hope \& Mattia 1995 and Clark \& Wells 1995). Symptoms and attention bias measures will be taken at three time points: Pre-treatment, Post-treatment,and at 3-month follow-up.

The study includes the following steps: a) initial assessment of participants' psychopathology and symptom levels; b) attention bias measurement; c) 8 sessions of ABMT/placebo control delivered as part of the CBGT sessions; d) two booster ABMT/Placebo treatments will be delivered at sessions 13 and 16 of the CBGT protocol. e) post-treatment assessment will include symptom and attention bias assessments. Finally, f) a three-month follow up assessment.

The goal of the study is to to test the effectiveness of ABMT as an add-on to established CBGT protocol for social anxiety disorder.

Eligibility Criteria:
Inclusion Criteria:

* A signed consent form
* Men and women between the ages of 18 and 60.
* Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV
* A minimum of a 1-year duration of SP
* SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
* Stable pharmacotherapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of CBGT.

Exclusion Criteria:

* Psychotic episode in the past or the present time.
* Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
* Another psychotherapeutic treatment during the study.
* Usage of neuroleptic medication.
* Change in medication status during the study.
* Substantial usage of drugs or alcohol in the present time.
* Poor judgment capacity (i.e., children under 18 and special populations).
Effect of Incentive Spirometry on Post-operative Pulmonary Complications After Bariatric Surgery

Today, obesity is the major concern and obese patients are at higher risk of developing pulmonary complications. Incentive Spirometry is widely used worldwide to reduce rates of pulmonary complications. In this study, Effect of Incentive Spirometry (IS) on Post Operative Bariatric Patients (Male and Female) will be studied on patients about sample size of 140 including male and female gender, BMI above 30 kg/m2 having Post Operative Bariatric Surgeries with chances of generating Pulmonary complications.

Research will be conducted in Shalamar Hospital Lahore and data will be collected through predesigned proforma. In previous studies some studies show positive and but some studies don't recommend Incentive Spirometry as a post operative Rehabilitation therapy.But this therapy device is still used in present days in Post Operative patients to prevent pulmonary complications. In this study we conclude the positive or negative effect of Incentive Spirometry.

Eligibility Criteria:
Inclusion Criteria:

* Patient having weight above 25 BMI
* Age between 18 years to 60 years
* having Post Operative pulmonary complication.
* Bariatric patients (Sleeve gastrectomy,Mini gastric Bypass,Sleeve gastrectomy to gastric bypass ,sleeve re do surgery)..

Exclusion Criteria:

* Patients weight below 25BMI.
* other abdominal surgeries.
* Patients having absence of teeth.
* Patients age below 18 years .
Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial

A common long-term side effect of anti-rejection (immunosuppressant) medications is skin cancer. This pilot clinical trial evaluates the feasibility of conducting a larger pivotal trial to examine the efficacy and safety of nicotinamide for prevention of keratinocyte carcinoma in solid organ transplant recipients. This pilot trial will transition into the pivotal trial if all feasibility targets are met.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Kidney, liver, heart, or lung transplant at least two years ago
3. History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ
4. Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus)
5. Able to attend follow-up visits
6. Able to speak and understand English (only for cognitive substudy)

Exclusion Criteria:

1. Use of mTOR inhibitor (sirolimus, everolimus) within the past 12 weeks
2. Biopsy-confirmed acute rejection episode within the past 12 weeks
3. Active liver disease (elevated AST or ALT \>3 times normal)
4. Severe renal failure (estimated glomerular filtration rate \<20 mL/min/1.73 m2)
5. Current carbamazepine or primidone use
6. Pregnancy and lactation
7. Gorlin syndrome or other genetic skin cancer syndrome
8. Solid organ or hematologic malignancy, invasive Stage II melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years, or invasive Stage I melanoma within the past two years
9. Untreated localized skin cancer (invasive squamous cell carcinoma, basal cell carcinoma, or keratoacanthoma) at baseline (the patient can enrol after skin cancer treatment)
10. Use of nicotinamide or niacin (250 mg or more daily) within the past 12 weeks
11. Use of field therapy for actinic keratoses within the past 12 weeks
12. Initiation of systemic chemoprevention within the past 12 weeks
Study Exploring the Effect of Music on Pain After Ventral Hernia Surgery

The purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.

After being informed about the study and potential risks and meeting eligibility criteria, all patients giving written informed consent will be scheduled for their hernia repair surgery. On the day of surgery, patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to listen to patient-chosen music during their surgery via headphones or just listen to silence via headphones. Pain and anxiety will then be assessed after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Adults having open retromuscular ventral hernia repair with mesh, with or without myofascial release for a hernia width ≤ 20 cm
2. Adults having open flank hernia repair that requires a myofascial release with mesh
3. Adults having parastomal hernia repair with mesh

Exclusion Criteria:

1. Primary language other than English, or lack of English language fluency
2. Hearing impairment, with or without use of hearing aids
3. Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and anxiety
4. Patients who will remain intubated after surgery
Optimized Treatment of Peginterferon Alfa 2a in Treatment Experienced Patients With HBV Related Liver Fibrosis

Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.

Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.

Main purpose: Comparing the improvement rate of liver fibrosis. Secondary purpose: Comparing the incidence of adverse events. Comparing the incidence of cirrhosis, hepatocellular carcinoma, and liver failure.

Comparing the rates of HBsAg and HBeAg serological conversion.

Eligibility Criteria:
Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
2. Receiving treatment of nucleoside/nucleotide analogues at least one year before recruited;
3. Age from 18 to 55 years old;
4. Normal liver function(ALT\<ULN,AST\<ULN and TBil\<ULN).
5. Undetectable hepatitis b virus DNA or less than 100IU/ml.
6. LSM between 6 and 12 kpa measured by fibroscan;
7. Liver ultrasound: normal or echo thickening, and portal vein diameter ≤ 12mm.

Exclusion Criteria:

1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
2. Pregnancy, lactation or female has plan of pregnancy within 18 months;
3. Accompanied with other active liver diseases(HAV, HCV, HDV, HEV, autoimmune liver disease, drug-induced liver injury, alcoholic liver disease, genetic metabolic liver disease, etc.)；
4. Accompanied with human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Accompanied with severe diabetes, autoimmune diseases etc. and other important organ dysfunctions;
6. Patients who fail to comply with this research arrangement and sign an informed consent form
7. Patients can not follow-up;
8. Investigator considering inappropriate.
D-Serine for Enhancing Cognitive Retraining for the Treatment of Schizophrenia

This study will examine the effectiveness of D-serine in increasing and sustaining the benefits of cognitive retraining in people with schizophrenia.

This study is based on the hypothesis that by increasing NMDA receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.

Patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Clinically stable
* Treated with antipsychotic medications for at least 6 months in the past, and on a stable dose of the same antipsychotic medication over the past month
* Not pregnant or lactating

Exclusion Criteria:

* Other current or past DSM-IV Axis I diagnosis
* Calgary Depression scale score \>10 or Simpson-Angus Rating Scale score \> 20
* Currently treated with clozapine, lamotrigine or carbamazepine, or defined as treatment refractory
* Substance abuse or dependence within the past 3 months, except for nicotine
* Wechsler Adult Intelligence Scale-Revised score \< 70
* Significant recent (within past 3 months) risk of committing suicide
* Abnormal thyroid function tests within the last 6 months
* Previous treatment with D-serine
* History of evidence of a medical or neurological condition that would expose the subject to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the trial
* Clinically significant abnormal laboratory test results at screening
* ECT treatment within the past two months
Paracervical Block for Pain Control in First Trimester Abortion

Many woman undergoing a surgical abortion receive a paracervical nerve block for pain reduction, in which lidocaine (a numbing medication) is injected around the cervix. These injections numb the cervix and possibly the lower part of the uterus. However, the injection can be uncomfortable and it is not well known whether it is effective in reducing pain. The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that paracervical block might have on that pain.

The investigators expect to have 120 women complete this study, between study sites at OHSU's Center for Women's Health and Planned Parenthood Columbia Willamette in Portland, OR. Every participant will still receive the standard oral medication for pain (ibuprofen) and anxiety (lorazepam). Eligible subjects will be at least 18 years of age, less than 11 weeks pregnant and have already decided to have a surgical abortion.

The primary outcome evaluated will be pain reported at time of cervical dilation. The investigators will assess pain at various time points (including secondary outcomes) immediately upon completion of the respective step and pain and satisfaction 30 minutes postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older
* Voluntarily requesting pregnancy termination
* Ultrasound confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age
* Good general health
* English or Spanish speaking
* Be able and willing to sign an informed consent and agree to terms of the study

Exclusion Criteria:

* Gestational ages over 11 0/7 weeks, due to routine misoprostol use at our institutions
* Incomplete abortion
* Required or requested narcotics or IV sedation (prior to randomization)
* Patients who refuse Ibuprofen and paracervical blocks
* Contraindications or allergies to lidocaine, ibuprofen or ativan
* Significant physical or mental health condition
* Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
* Patients with known hepatic disease
* Women, who in the opinion of the investigator are not suitable for the study protocol
Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects

The purposes of this study are to: learn about the safety of the study drug (NBI-98854); learn how subjects tolerate the study drug; and evaluate and compare the pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of the investigational study drug after taking it alone and with ketoconazole. Ketoconazole is known to affect the PK of many drugs and is studied to more safely prescribe medications.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteer, 18 to 40 years of age.
* Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
* Female subjects must not be pregnant, given birth within 1 year of study start, or breastfeeding.
* Be in good general health and expected to complete the clinical study as designed.
* Have a body mass index (BMI) of 18 to 30 kg/m2 (both inclusive).

Exclusion Criteria:

* Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.
* Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start.
* Report more than two alcoholic beverages daily or more than 14 alcoholic beverages weekly withing 7 days of study start.
* Report use of tobacco and/or nicotine-containing products within 3 months of study start.
* Have a known history of neuroleptic malignant syndrome.
* Have a significant risk of suicidal or violent behavior.
* Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.
* Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
* Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
* Had a blood loss greater than or equal to 500 mL or donated blood within 56 days of study start.
* Have had previous exposure with NBI-98854.
Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft

This study looks to compare the clinical effects of StellaLife VEGA Oral Care Kit with chlorhexidine mouth-rinse on patient comfort, wound healing, wound epithelialization, bacterial levels, and colonization of the wounds.

A total of 60 participants will be recruited from those needing and have been treatment planned for a free gingival graft surgery to increase keratinized gum. The study subjects will be randomly allocated to either negative control group (NC), chlorhexidine group (C) or StellaLife group (S) by randomization done using a computer-generated table.

The NC group is provided normal saline mouth-rinse to rinse 2 times per day along with placebo gel to be applied 2 times and placebo oral spray. The S group will use StellaLife Oral Care mouth-rinse, gel and spray 2 times per day. The C group will use chlorhexidine mouth-rinse and placebo gel and spray 2 times per day. All groups beginning the same day and continuing for the duration of two weeks. All patients will receive a protective splint. Following this, subjective and objective measurements on the success of the mouthwash and oral care kit will be measured.

Patients will be evaluated post operatively following surgery as mentioned below:

* Wound Healing Assessment and Epithelization Assessment: Postoperative Days 1, 5, 14, 21 and 28
* Oral Health Impact Profile-14 and Functional Pain Scale: Starting on the day of the surgery and Postoperative Days 1, 5, 14, 21 and 28
* Wound Exudate assessment: Samples collected on Postoperative Days 1, 5, 14, 21 and 28
* Wound Plaque assessment: Starting on the day of the surgery and Postoperative Days 1, 5, 14, 21 and 28

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥18 years,
* No history of medication affecting periodontal status in the last 6 months,
* No history of allergy to study medication or material,
* No use of tobacco,
* No history of pregnancy or lactation or contraceptive medication
* Good oral hygiene.

Exclusion Criteria:

* Previous palatal surgery
* Patient on anticoagulant therapy
* Uncontrolled diabetes,
* Rheumatoid arthritis,
* Osteoporosis.