cyrilzakka/clinical-trials huggingface dataset:
Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis

This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.

Specific Aims of Study

1. To determine the safety profile of an intravenous omega-3 fat emulsion (Omegaven™)
2. To determine if established PN associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.

Eligibility Criteria:
Inclusion Criteria:

1. Age \< 18 years old
2. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days, may be inpatient or outpatient
3. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
4. Direct bilirubin \> 2.0 mg/dl
5. Signed patient informed consent
6. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, or the use of ursodiol (i.e., Actigall®)

Exclusion Criteria:

1. Pregnancy
2. Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency)
3. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
4. The parent or guardian or child unwilling to provide consent or assent
5. Patients known to be allergic to fish or egg protein and patients with the following contraindications to Omegaven™ use:

   * Impaired lipid metabolism
   * Severe hemorrhagic disorders
   * Unstable diabetes mellitus
   * Collapse and shock
   * Stroke/embolism
   * Recent cardiac infarction
   * Undefined coma status
Comparison of Treatment Modalities in Poor Responders Undergoing IVF

The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
* Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:

  * advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
  * a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or
  * an abnormal ovarian reserve test (antral follicle count, \<7 follicles or anti-Mullerian hormone, \<1.1 ng/ml).
Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus

The primary objective of this study is to evaluate the short-term antiviral potency of GS-9131 functional monotherapy compared to placebo-to-match (PTM) GS-9131, each administered once daily with the existing failing antiretroviral (ARV) regimen as demonstrated by the proportion of participants achieving human immunodeficiency virus ribonucleic acid (HIV-1 RNA) \> 0.5 log10 decreases from baseline after up to 14 days of therapy in HIV-1 positive, ARV treatment experienced adult participants with nucleos(t)ide resistant virus.

This is a two-part study. Part 1 consists of three cohorts: 2 Sentinel Cohorts and 1 Randomized Cohort. Eligible participants from Part 1 will proceed to Part 2 followed by an optional open-label extension.


Eligibility Criteria:
Key Inclusion Criteria:

* Plasma HIV-1 RNA ≥ 500 copies/mL at screening Visit
* Currently taking a failing ARV regimen that contains 2 NRTIs and a NNRTI
* No prior or current ARV regimens containing integrase inhibitor (INSTI) or protease inhibitor (PI)
* Screening genotype must show at least the protocol defined resistance mutation profile

Key Exclusion Criteria:

* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
* Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
* Use of an investigational drug other than the study drug
* Individuals with chronic hepatitis B virus (HBV) infection are not permitted to participate
* Active tuberculosis infection

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Imagery Rescripting and Imaginal Exposure for Social Anxiety: Mechanisms and Outcomes in an Analog Sample

This study will recruit 100 participants who self-report high symptoms of social anxiety (Social phobia inventory \>30). Participants will be randomly assigned to receive either one analog intervention of Imagery Rescripting (IR) or Imaginal Exposure. We will test the efficacy and mechanisms behind each interventions.

After being informed about the study potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. They will be randomly assigned to two conditions (Imagery rescripting Vs. Imaginal exposure) at a 1:1 ratio. Participants will attend three \~1 hour online ZOOM sessions (pre-assessment and measurement, intervention, and post assessment and measurement).

Assessors will be blind to the treatment condition.

Eligibility Criteria:
Inclusion Criteria: SPIN scores \>= 30 -

Exclusion Criteria:

can't report a negative imagery related to a future social scenario. Attending active psychotherapy sessions.

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Gene-Polymorphies in the P2X7 Gene in Patients With Osteoporotic Fractures

We are looking after gene-polymorphies in the p2x7-gene in patient with osteoporotic fractures.


Eligibility Criteria:
Inclusion Criteria:

* hip fracture, no dementia, low energy fracture

Exclusion Criteria:

* high energy fracture
Cardiorenal and Metabolic Effects of Nighttime Eating

In this study, the investigators are trying to find out of the effect of nighttime eating on metabolism, cardiorenal, hormonal and circadian rhythm, and a study was conducted to examine the effects of diseases that are quite common in internal medicine practice, such as type 2 diabetes mellitus, chronic kidney disease, hypertension, metabolic syndrome and sleep disorders.

The Coronavirus Disease (COVID)-19 pandemic, which emerged in recent years, has deeply affected living conditions and has had an impact on societies on eating habits. As shown by some studies, it has been shown that night sleep habits have changed and night nutrition and calorie intake have increased due to reasons related to staying at home, working remotely, and isolation during the pandemic period. However, some recent studies have shown a relationship between nighttime eating and conditions that predispose to metabolic syndrome, such as obesity and hyperglycemia. At the same time, prospective studies on the details of the cardiorenal and metabolic effects of night feeding behavior, which is one of the important predisposing factors for metabolic syndrome, are quite insufficient. Although the importance of nighttime eating habits has begun to be emphasized in recent years with recent randomized cross-controlled studies on this subject, there are not yet enough prospective studies on this subject. In this respect, studies on nighttime eating behavior, which is common in society, are important.In this study, a cross-over design study was conducted on the effectiveness of nighttime eating on metabolism, cardiorenal, hormonal and circadian rhythm, and a study was conducted to examine the effects of diseases that are quite common in internal medicine practice, such as type 2 diabetes mellitus, chronic kidney disease, hypertension, metabolic syndrome and sleep disorders. The investigators aim to create a new and additional perspective on the management, treatment and follow-up of common diseases and to contribute to raising awareness about night nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Being willing to adapt to the desired feeding time and calories
* Body mass index (BMI) is between 18-30
* Not having any systemic disease, not using chronic medication

Exclusion Criteria:

* -\<18, \>65 years old
* Failure to comply with the regulated nutrition program
* BMI between \<18 and \>30
* Presence of systemic disease: E.g. Diabetes Mellitus, Chronic Kidney Disease, Coronary Artery Disease, Hypertension etc.
* Inability to have polygraphy
* Chronic drug use
NP2 Enkephalin For Treatment of Intractable Cancer Pain

The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.

Chronic severe pain remains a significant unmet medical need in patients that have progressive cancer. Existing treatments have limited efficacy and also suffer significant side effects. This is a multi-center, randomized, double blind, placebo-controlled clinical trial designed to evaluate the impact of intradermal injection of NP2 in subjects who have intractable pain due to malignant disease. NP2 is a gene transfer vector engineered to express human preproenkephalin, a gene naturally involved in pain control. Delivery of NP2 directly to the site of pain caused by cancer is intended to provide increased Enkephalin peptides, which bind to opioid receptors, that may allow better pain control.

Eligibility Criteria:
Main Inclusion Criteria:

* Histologically confirmed malignant disease.
* Intractable pain related to malignancy.
* Females must be postmenopausal or practicing birth control.
* Able to provide appropriate written consent.

Main Exclusion Criteria:

* Positive pregnancy test prior to receiving study treatment.
* Serious uncontrolled medical condition other than malignancy (e.g. congestive heart failure, coagulopathy, uncontrolled diabetes).
* Evidence of active Hepatitis B, Hepatitis C, or HIV infection.
* Evidence of viral, bacterial, or fungal infection in the planned treatment area.
Anesthesia Methods on Percutaneous Kyphoplasty

The aim of this research is to examine the effects of the anesthesia method and preoperative characteristics on postoperative results and complications in patients who underwent percutaneous kyphoplasty (PKP).

Method: Patients were split into three groups according to anesthesia methods: (1) General Anesthesia (Sedation), (2) Central Block (Spinal and Epidural Anesthesia), (3) Peripheral Block \[Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB)\]. Patients' pain values, hemodynamic parameters, additional need for sedation, and perioperative and postoperative complications were recorded prospectively together with Visual Pain Scales (VAS).

Demographic characteristics (body mass index \[BMI\], gender, age, ASA use, pain values \[VAS\] before surgery, analgesic use habits, anesthesia technique chosen by anesthesiologist blind to the study, perioperative hemodynamic parameters, additional opioid during surgery, parol? or anesthetic need, perioperative complications \[patients who willingly stopped the procedure during the intervention, moaning, hypotension, hypertension, bradycardia, respiratory depression, desaturation and need for mask ventilation\] were taken from the records of the individuals with the treatment of PKP between 01/22-07/22 after the approval of the SBÜ Bursa Yüksek İhtisas EAH Ethics Committee (2021-KAEK-25 2021/12-09) and the patient's consent. In addition, the first mobilization time, additional analgesic need, total amount of analgesic used in 24 hours, discharge time, VAS values at 2, 6,12, and 18 hours, complications (nausea, vomiting, pain, delirium, respiratory insufficiency, infection, deep vein thrombosis, pulmonary embolus, need for re-operation, need for intensive care or mechanic ventilator) were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18-100 ages kyphoplasty surgery patients
* written consent form received

Exclusion Criteria:

* The patient's unwillingness to participate in the study
* inability to communicate with the patient
* the patient does not speak Turkish,
* previous CVO, presence of cognitive impairment
Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.

This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.

Patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Weekly counseling sessions, conducted by both doctors and nurses, aimed to educate patients on regulating their regular dietary intake to meet specific energy, protein, and other macronutrient requirements. Dietary advice provided precise instructions on food type and quantity, meal frequency, and calorie or protein intake to ensure a daily energy intake of approximately 30 kcal/kg. All patients received definitive thoracic radiotherapy with total radiation doses of 60-68 Gy, concurrent with weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed unresectable stage IIIA-IIIC non-small cell lung cancer.
* Recieved definitive concurrent chemoradiotherapy.
* Pretreatment PG-SGA score A or B.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Estimated life expectancy of at least 6 months.
* Without contraindication for chemoradiotherapy.

Exclusion Criteria:

* Severe impairment of intestinal function, or intolerance of enteral nutrition.
* Severe vomiting, gastrointestinal bleeding, or intestinal obstruction.
* Severe malnutrition, or intolerance of chemoradiotherapy.
Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)

The study is stratified cluster randomized trial. The study population will include adults with T2D and presumed NASH.

The study is a multi-centered, stratified cluster randomized controlled, open-labeled two-phase study. Clusters will be independent LMC clinic sites with patients as participants. The use of the stratified cluster randomization design will help prevent the potential for cross-contamination of screening methods.

Study participants who meet eligibility criteria undergo NASH screening. Everything, other than routineness of screening, is maintained the same in both the groups. The screening intervention received is determined by the site of the participant's provider. All participants enrolled will undergo biochemical screening. Regardless of randomization, any participants meeting biochemical cut-offs (FIB-4 index ≥1.3 or NFS \>-1.455) will undergo FibroScans. Clinical data and a health-related quality of life assessment will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of T2D
* Age 18 - 80 years
* BMI \>25 kg/m2 or waist circumference ≥102 cm in men and ≥88 cm in women
* Informed consent

Exclusion Criteria:

* Known history of biopsy-proven NAFLD or NASH, hepatitis B, hepatitis C, HIV, liver cirrhosis, hemochromatosis, drug-induced hepatitis, alcohol-related or autoimmune hepatic disease, history of hepatic decompensation, solid organ transplant, or primary liver cancer, based on electronic medical record
* History of alcohol abuse (≥30 g/day or ≥3 drinks/day for males and ≥20 g/day or ≥2 drinks/day for females)
* Unstable patients with T2D (e.g. end stage renal disease on dialysis, late stage cancer, acute cardiovascular event or any hospitalization in the past 3 months). Note - Emergency room visit without hospitalization is not exclusionary
* Pregnancy/lactation
* Presence of implanted electronic medical device (i.e., pacemaker, as FibroScan cannot be performed)
* Language barriers (i.e. inability to read the consent form translated in any of the multiple languages)
Covered Versus Uncovered Biliary Stents for Biliary Malignancies

Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.

Consecutive patients with malignant strictures of the extra-hepatic biliary tree considered unfit for surgical excision Placement of covered or uncovered metal stents in patients with and without gallbladder on the basis of a computer-generated randomization list Evaluation of clinical outcome, survival, complications, and quality of life. Evaluation of the cost and efficacy of the two types of metal stents.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree
* not eligible for surgical intervention
* able to provide informed consent

Exclusion Criteria:

* benign biliary obstruction
* previous surgery of the biliary tract
* life expectancy \< 3 months
Recovery Strategies Based on Mindfulness and Physical Exercise on Levels of Stress and Inmunoglobulin A

The present study aims to compare the differential effects of mindfulness meditation (MBI) and physical exercise (PE) on different stress, academic performance and health variables (self-report means and biological measure of IgA levels). A controlled trial of three groups is proposed, with pretest, posttest and two follow-ups at 1 and 3 months that would be developed among the Guardia Civil (Spanish military police) non-commissioned officers and officers academies.

Recovery from fatigue and daily stress involves mentally disconnecting from the journal. To achieve this disconnection (or psychological detachment), research has shown that engaging in a variety of interesting and motivating activities for individuals after the day allows them to achieve this disconnected state of mind and, consequently, facilitates recovery from work.

Previous research has shown that two of the most effective recovery activities are physical exercise (PE) and mindfulness meditation (MBI), although the results on the differential effects of the two are not conclusive (Karabinski et al, 2021; Steed et al., 2021; Wendsche et al., 2021).

Thus, the present study aims to compare the differential effects of MBI and PE on different stress, academic performance and health variables (self-report means and biological measure of IgA salivary levels). A non-randomized controlled trial (participant chooses to take of three groups proposed) with pretest, posttest and two follow-ups at 1 and 3 months. It would be developed among the Guardia Civil (Spanish military police) non-commissioned officers and officers academies (N ≥ 150). An MBI (focused attention meditations), an aerobic PE program (running with mental association strategies) and an inactive control / waiting list (LE) condition will be contrasted.

The dependent variables considered are: 1) recovery experiences; 2) perceived stress; 3) general health; 4) academic performance; 5) positive and negative affect; 7) daily states of fatigue, stress, psychological distancing, mindfulness, and sleep; 8) IgA levels in saliva. The intervention program is structured for four weeks, during which the two intervention groups will carry out their recovery strategy (MBI or PE), starting and increasing the practice 5 minutes every two weeks. The control group will continue as usual. The investigators believe that this study is a quasi-pioneering initiative because of its theme, and will have an important scientific and technical impact. The importance of the topic addressed in terms of health and academic performance is associated with important contributions in terms of knowledge transfer to the educational field and society in general.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.

Exclusion Criteria:

* Currently practicing any type of meditation regularly.
* To have a physical or mental illness that prevents mindfulness practice.
* To take medication that interferes with salivary inmunoglobulin A (SIgA).
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
* The renal cold ischemic time must be \< 36 hours.
* The age of the donor must be between 15 and 65 years.

Exclusion Criteria:

* Patients who are recipients of multiple organ transplants, including more than one kidney
* Patients who have previously received an organ transplant which failed within one year
* Patients with current panel reactive T-cell antibody titers of 50% or more
* Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant

Other protocol-defined exclusion criteria may apply.
Clinical Trial of CBASP for Individuals With Co-occurring Chronic Depression and Alcohol Dependence

This study examines the effectiveness of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults who are chronically depressed and alcohol dependent.

This study examines the effectiveness of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults who are chronically depressed and alcohol dependent. Participants will receive a 20-session course of CBASP psychotherapy over a period of 21 weeks and will be assessed for severity of pretreatment psychological abuse and trauma as well as pre and posttreatment interpersonal functioning. Two primary hypotheses are to be tested: 1) demonstrate that CBASP is effective in reducing depressive symptoms (Hamilton Rating Scale for Depression-24 ratings) and alcohol consumption (drinks per drinking day) in this chronically depressed alcohol dependent cohort when posttreatment ratings are compared to pretreatment levels; and 2) demonstrate that acquisition of feeling safe with the therapist and acquisition of the ability to perceive the interpersonal consequences of one's behavior will significantly increase from pre to posttreatment levels and will be associated with reductions in drinking and depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of a current major depressive disorder (e.g., Major Depression, Dysthymic Disorder) for a minimum of two years
* Clinical diagnosis of alcohol dependence during the last thirty days
* Interest in changing one's drinking and alleviating depressive symptoms

Exclusion Criteria:

* Please call study site for additional information