cyrilzakka/clinical-trials huggingface dataset:
Mechanisms of Lipodystrophy in HIV-Infected Pateints

The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.

The project therefore has the following aims: 1) to characterize metabolic abnormalities and changes in body fat distribution, 2) to develop objective criteria for defining the syndrome and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the lipodystrophy syndrome in HIV-infected patients.

A 2-year long prospective, randomized, double blind, placebo-controlled study in 200 asymptomatic HIV (+) patients to compare two equally effective antiretroviral regimens, one with and the other without a protease inhibiotor. We will study body fat distribution by anthropometry and magnetic resonance imaging and will measure insulin sensitivity (in a subset of patients), plasma lipoproteins, glucose tolerance and other metabolic variables. We will study expression of an array of adipocyte specific proteins/transcription factors involved in adipocyte differentiation, insulin action and lipoprotein metabolism in fat biopsy samples obtained before and after institution of therapy.

Eligibility Criteria:
Inclusion Criteria:

* HIV Positive
* No previous antiviral therapy
* 18 to 70 years of age

Exclusion Criteria:

* Patients with opportunistic infections or AIDS.
* Active intravenous drug users.
* Patients on corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, dehydroepiandrosterone, oxandrolone, megace.
* Patients with diabetes mellitus.
* Patients with moderate to heavy alcohol consumption ( greater than 15 drinks per week).
* Pregnant or premenopausal women, unless surgically sterilized or highly unlikely to conceive (defined as women taking oral contraceptives, using barrier protection during intercourse or with a copper intrauterine device in place for \> 3 months without complaints and a negative serum or urine pregnancy test within 30 days of study entry).
* Acute or chronic liver diseases; elevations of liver transaminases by more than two and one half times above the upper limits of normal ( SGOT \> 105 U/L, SGPT \> 120 U/L, ) or a total bilirubin of \> 1.5mg/dL.
* Anemia (hematocrit \<32%).
* Abnormal thyroid function tests.
* Weight loss \>10% from baseline in the past year.
* Recent (within the past year), history of suicide attempt.
Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients

This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and Truvada (tenofovir and emtricitabine).


Eligibility Criteria:
Inclusion criteria

* male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection.
* Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
* Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Exclusion criteria

* Age \< 18 years
* Pregnant female patients
* Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or Truvada (tenofovir and emtricitabine).
* Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
* Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment aspartine transaminase (ASAT) or alanine transaminase (ALAT) \> 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised \< 5 ULN.
* Viramune (nevirapine) should not be readministered in patients who previously had ASAT or ALAT \> 5 ULN during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine)
* Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine
* The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended.
Value of an Intervention to Enhance Adherence in Glaucoma Patients

A one-year, randomized, attention placebo-controlled trial investigating the value of comprehensive adherence specific interventions, over the course of one year, to enhance adherence in both (a) newly diagnosed open-angle glaucoma, or ocular hypertension patients, naive to medical therapy and (b) those who have failed monotherapy with any prostaglandin analogue (and are therefore candidates for adjunctive therapy) who then are randomized to receive only travoprost monotherapy. Subjects will be randomized to two different interventions involving direct physician education, each of which will take approximately the same amount of physician time: The first will be intensive adherence education that will continue throughout the year. The second will be intensive eye care education, but without any direct adherence education. All patients participating in the study will be monitored for adherence by the TDA. The study will demonstrate for the first time the role of adherence-specific training in improving patient adherence and will validate the TDA in monitoring and improving adherence in glaucoma. This will correlate with prior work that has documented that greater adherence is associated with marked improvement in intraocular pressure (IOP) control. A second goal will be seeing whether improving adherence will change the course of glaucoma therapy by making therapeutic failures into therapeutic successes by reducing the need for adjunctive therapy using only monotherapy with travoprost.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with glaucoma
* Suboptimally controlled patients with glaucoma
* Untreated baseline IOP greater than 21 mm Hg but less than 32 mm Hg
* Patients who have not responded satisfactorily to PGA therapy
* Patients who are about to have adjunctive therapy administered
* Patients who consent to participate in this trial

Exclusion Criteria:

* Glaucoma patients with high pressure
* Advanced glaucoma
* Patients with side effects to PGA therapy
* Unwilling to participate
Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site.

Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs.

The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias.

INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.


Eligibility Criteria:
Inclusion Criteria:

* Adults (at least 18 year-old patients)
* Umbilical trocar incision \> 10 mm
* Any of the following risk factors: BMI \> 27, Absence of primary umbilical hernia or smaller than 1 cm, active smoking, malnutrition, anemia, oncological surgery, diabetes, heart failure, chronic kidney disease, chronic liver disease, collagen disease, chronic pulmonary disease.

Exclusion Criteria:

* Umbilical trocar incision \< 10 mm
* Umbilical hernia \> 10 mm
* Hernia surgery or incisional hernia at the trocar site
* Conversion to laparotomy
* Pregnancy
* Ascites or cirrhosis
* Clasification of the American Anestesiology Classification IV o V.
* Inadequate follow-up
* Patients included in any other trial
* Patients with life expectancy \< 12 months
* Patients with any kind of sensibility to Duramesh
Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)

The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection following elective colorectal surgery in Chinese adults. This study is designed to demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this participant population.


Eligibility Criteria:
Inclusion Criteria:

- Participant is scheduled to undergo elective colon or colorectal surgery by

laparotomy that is scheduled in advance with adequate time prior to surgery to

complete preoperative bowel preparation.

- Participant is a Chinese adult between the ages of more than 18 years old and

less than 81 years old.

- Participant is highly unlikely to conceive.

Exclusion Criteria:

* Participant is undergoing emergency colon or colorectal surgery.
* Participant requires a second planned colorectal surgery or other surgery requiring antibiotic prophylaxis within the 4-week follow-up period.
* Participant is undergoing laparoscopic-assisted surgery.
* Participant is undergoing an isolated rectal procedure.
* Participant has a decompensated intestinal obstruction.
* Participant has active inflammatory bowel disease involving the colon (i.e.,

ulcerative colitis or Crohn's disease).

* Participant is scheduled to undergo an elective colorectal procedure for revision of a previous operation involving a large bowel resection.
* Participant has a bacterial infection at the time of surgery.
* Participant requires or is anticipated to need the administration of other (nonstudy therapy) systemic antimicrobial therapy within 1 week prior to surgery or at any time during this study.
* Participant is anticipated to receive either antibiotic or antiseptic peritoneal lavage during the surgery.
* Participant has a history of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to ertapenem sodium, ceftriaxone sodium, metronidazole, penicillin, or any cephalosporin, beta(β)-lactam, or nitroimidazole agents.
* Participant is breast feeding or plans to breast feed prior to the completion of the study period.
* Participant has neutropenia.
* Participant with immunosuppression due to an underlying disease, chronic

immunosuppressive therapy, or use of high-dose corticosteroids.

* Participant has a rapidly progressive or terminal illness.
* Participant is considered unlikely to survive through the expected 4-week study period.
Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)

The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent to participate in the study;
2. Adult patients of either sex aged ≥ 40 years;
3. Patients with diagnosis of moderate to very severe COPD according to Gold Initiative for Chronic Obstructive Lung Disease (GOLD) updated 2019 (GOLD Stage 2-4);
4. COPD assessment test (CAT) score ≥ 10 at initiation of BDP/FF/G fixed combination;
5. History of \>1 moderate or severe COPD exacerbation during the previous year.
6. Patients in treatment with BDP/FF/G as per local clinical practice and according to Trimbow® Summary of Product Characteristics (SmPC).

Exclusion Criteria:

1. According on Investigator's judgement, patients unable to comply with the requirements of the study (e.g. inability to attend all the planned study visits according to the time limits included) or patients with poorly controlled concomitant severe diseases or conditions that could interfere with the study participation;
2. Participation in an interventional clinical trial within 30 days prior to enrolment into the present study.
Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia

A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)

This is an open label phase II clinical study to evaluate the safety and pharmacokinetics of oral encochleated Amphotericin B (CAMB/MAT2203) for prevention of invasive fungal infections in approximately 30 patients undergoing induction therapy for AML/ALL.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed AML/ALL receiving chemotherapy inducing neutropenia \< 500 cells/mm3
* Able to have all screening tests done to allow for study drug administration no later than 5 days after start of chemotherapy
* Sign informed consent
* ≥ 18 years of age

Exclusion Criteria:

* Known hypersensitivity to amphotericin B, specifically anaphylactic reaction
* Fungal induced fever (≥ 38°C)
* Proven, possible or probably invasive fungal infection in previous 12 months
* Serum galactomannan index (GMI)≥ 0.5 at screening
* Pulmonary infiltrates at screening
* Current treatment with amphotericin B
* Sever comorbidity other than underlying haematological disease
* Prolongation of corrected QT interval
* History of convulsion
* Pregnant or breastfeeding
* Females of childbearing potential who do not practice sexual abstinence or who do not agree to use appropriate contraceptive methods
* Presence of hepatic disease
* Total bilirubin \> 3 x upper limit of normal
* Age-adjusted creatinine clearance \< 30 mL/minute
* Participating in any other clinical study
Optimizing Psychological Treatment for Pain After Breast Cancer: A Pilot Study

The present study is a pilot study that aims to evaluate the feasibility, validity, and preliminary efficacy of three psychological treatment components for pain after breast cancer, which will be evaluated in a larger trial following completion of the present pilot study.

The present pilot study is a precursor for a following larger trial and aims to evaluate the i) feasibility, ii) validity, and iii) preliminary efficacy of the three treatment components that will be further investigated in a subsequent larger trial. The present pilot study will employ the same design as will be used in the subsequent larger trial, namely the Multiphase Optimization Strategy (MOST). Specifically, in the subsequent larger trial, MOST will be used to evaluate the efficacy and change processes of three psychological treatment components selected from so-called "third wave" cognitive therapies (CTs), which have been shown to be efficacious in the treatment of pain after breast cancer.

The overall hypothesis is that the selected third wave CT components will target key maintaining psychological factors in pain, thus leading to reductions in the primary outcomes of pain intensity and -interference. Specifically, we hypothesize that:

1. Mindful attention practices will increase attentional control (i.e., the ability to intentionally focus and intentionally shift one's attention), thereby reducing pain hypervigilance, leading to reductions in pain intensity and -interference.
2. Decentering practices will reduce fusion with thoughts (i.e., getting caught up in one's thoughts and acting automatically in response to thoughts), thereby reducing pain catastrophizing, leading to reductions in pain intensity and -interference.
3. Values and committed action (i.e., behavior linked to values and goals) will increase acceptance of discomfort and reduce avoidant behavior, leading to reductions in pain intensity and -interference.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of primary breast cancer stage I-III
* Min. 6 months post breast cancer treatment (i.e., surgery, chemotherapy, and/or radiotherapy). Endocrine treatment, e.g., Letrozole or Tamoxifen, and/or Zoledronic acid and/or Herceptin treatment is allowed during study participation
* Pain corresponding to a min. pain score of \>= 3 on pain intensity or pain interference measured by 11-point Numeric Rating Scales (NRSs)
* Sufficient ability to communicate in Danish
* Sufficient ability to participate in an online-delivered intervention

Exclusion Criteria:

* Metastatic breast cancer (stage IV)
* Breast cancer recurrence
* Bilateral breast cancer
* Other current cancer disease
* Other current pain condition (e.g., fibromyalgia)
* Current severe psychiatric disorder (e.g., psychosis)
* Inability to communicate in Danish
* Inability to participate in an online-delivered intervention
Rule Out of ACS in Primary Care Using a Decision Rule for Chest Pain Including Hs-troponin I POCT

The goal of this clustered, diagnostic randomized controlled trial is to study a clinical decision rule including a high-sensitive troponin I point of care test in patients with chest pain in primary care.

The main questions it aims to answer are:

1. Can unnecessary referrals to secondary care be reduced by the use of a clinical deci-sion rule in patients with new onset, non-traumatic chest pain in primary care? Compared to current daily practice.
2. What is the accuracy (sensitivity, negative prediction value) of the clinical decision rule for excluding ACS and MACE at 6 weeks and 6 months?

This clustered, diagnostic randomized controlled trial will included patients with acute chest pain consulting their general practitioner. Practices in the intervention group will use a clinical decision rule consisting of the Marburg Heart Score and a high-sensitive troponin I point of care test to exclude acute coronary syndrome (ACS) and decide upon referral. Practices in the control group will apply usual care following local guidelines.

An independent endpoint committee consisting of a cardiologist and general practitioner will adjudicate the final diagnosis. Primary endpoints are ACS and Major Adverse Cardiac Events. A delayed reference standard of 6 months will be used.

For high sensitive troponin I measurement, the Siemens Atellica VTLi immunoassay analyser is used.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Acute chest pain
* Seen by general practitioner

Exclusion Criteria:

* \<1 hour since onset of symptoms
* Inability to speak or understand Dutch
* Hemodynamic instability
Pre-biopsy With Dynamic Acquisitions

This study is being done to test the ability of an investigational mammography camera to find small tumors in patients' breasts.

If you agree to take part in this study, you will be asked to remove your clothes from the waist up and put on a gown. A female technologist will give you an injection of Tc-99m sestamibi in a vein in your arm. This is a drug routinely used for breast imaging. About 10 minutes after your injection, you will be asked to sit in a chair for about 40 minutes. The technologist will position your breast between two small cameras. The cameras will apply a very light compression to your breast to make sure there is no movement during the picture. We will take two pictures of each breast. Each picture takes 10 minutes. You will also be asked to fill out a short questionnaire. If you are found to have additional breast lesions, your doctor and radiologist will be notified so that additional imaging or biopsies can be performed.

Eligibility Criteria:
Inclusion Criteria:

* Have a lesion on Mammogram, Ultrasound or MRI that measured \< 2 cm and considered suspicious or suggestive of malignancy
* Scheduled for biopsy of lesion
* \> 18 years of age
* Negative pregnancy test, postmenopausal, or surgically sterilized

Exclusion Criteria:

* Prior needle biopsy
National Longitudinal Cohort of Hematological Diseases

Background Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in hematology. The purpose of this study is to analyze the incidence and risk factors of major blood diseases, the treatment methods, prognosis and medical expenses of these patients in China.

Method The study will include patients diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders, blood infection or received bone marrow transplantation in the investigating hospitals from January 1, 2020, and collect basic information, diagnostic and treatment information, prognosis information, as well as medical expense information from medical records. In its current form, the NICHE registry incorporates historical data (collected from 2000) and is systematically collecting prospective data in two phases with broadening reach, and prospectively follow-up to collect the prognosis information.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders or received bone marrow transplantation in the investigating hospitals from January 1, 2020.

Exclusion Criteria:

* Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.
* Alcohol and drug addictions affect their ability to comply with study requirements.
* According to the investigator, there are conditions that may endanger the patient's safety or affect his/her compliance.