cyrilzakka/clinical-trials huggingface dataset:
Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

The purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral therapy.

Each year, more than 2 million children are born to HIV-infected women. The World Health Organization (WHO) recommends that these infants receive cotrimoxazole (CTX) prophylaxis starting at 4-6 weeks of age until the period of infant HIV transmission risk is over, and the infant is known to be HIV-uninfected. There is also increasing interest in studying CTX prophylaxis given to all infants of HIV-infected women at the time of initiation of replacement feeding, regardless of infant HIV infection status, to mitigate the high risk of infant morbidity and mortality associated with formula feeding in the developing world. However, infant in utero exposure to maternal antiretroviral drugs can lead to hematologic toxicities in infants. It is critical to know whether infant CTX prophylaxis exacerbates the hematologic toxicity associated with perinatal ARV exposure. This question, with broad public health implications, has never been studied.

We will study the hematologic toxicity associated with CTX prophylaxis given to infants exposed to maternal HAART in Botswana. We will use existing data from a large cohort that did not receive CTX, and enroll a smaller cohort that does receive CTX according to Botswana national guidelines.

Eligibility Criteria:
Both maternal and infant criteria need to be met:

Maternal Inclusion Criteria:

* documented HIV infection
* taking 3-drug highly active antiretroviral therapy at any point during pregnancy (note: can include 2 NRTI+NNRTI, 2NRTI+PI, or 3 NRTI)
* 21 years of age or older, and able and willing to sign informed consent
* Proof of Botswana Citizenship

Maternal Exclusion Criteria:

* involuntary incarceration

Infant Inclusion Criteria:

* younger than 42 days of age
* able to be brought to regular visits at study clinic until at least 6 months postpartum

Infant Exclusion Criteria:

* known pre-existing birth anomalies resulting in a high probability that the baby will not survive to 6 months
* known hypersensitivity to cotrimoxazole
Perioperative Troponin I and NT Pro-BNP in Lung Resection

After lung resection, troponin elevation may be regulated by mechanisms other than myocardial ischemia. Perioperative natriuretic peptides measurement may help identify changes in ventricular function during thoracic surgery. Integrating both cardiac biomarkers may improve the predictive value for cardiovascular complications after lung resection.

Objectives: To evaluate the incidence and magnitude of perioperative N-terminal pro brain natriuretic peptide (NT-proBNP) and high-sensitivity troponin I (Tn I) elevation in patients undergoing pulmonary resection and its predictive value for cardiovascular complications. Methodology: Prospective, multicenter, observational cohort study in patients \>45 years undergoing elective thoracic surgery for lung resection. Cardiac biomarkers Tn I and NT-proBNP will be measured preoperatively and at postoperative days 1 and 2. Risk score for major cardiovascular postoperative complications will be calculated depending of both biomarkers perioperative changes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥45 years old
* Patients undergoing elective surgery for lung resection

Exclusion Criteria:

* Patients undergoing urgent, emergent, or nonthoracic surgery
* Patients or family did not consent to participate
* Presence of symptoms related with infection or sepsis
* Patients with a documented history of severe heart failure and/or ejection fraction lower than 30%
Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

The purpose of our study is to use a flaxseed-based nutritional supplement in combination with exercise training (walking) for improving cholesterol levels. We hypothesize that exercise training will improve cholesterol profile and that adding supplementation with a flaxseed nutritional supplement will further improve cholesterol profile.

Flax supplementation and exercise training each have small beneficial effects for improving blood lipid profile and reducing cardiovascular disease risk. Flax lignan, a phytoestrogen found in flaxseed is thought to be the active compound responsible for the cholesterol-lowering effect of flaxseed. Our purpose is to combine an exercise training program (walking) with flax lignan supplementation for improving blood lipid profile.

Comparisons: Walking (6 days per week) plus flax lignan (500 mg per day) compared to walking plus placebo.

Eligibility Criteria:
Inclusion Criteria:

* 50 years or older

Exclusion Criteria:

* Currently taking medication for cholesterol
* Smoker
* Diabetic
* Gastrointestinal disease
* Females on hormone replacement therapy
* Currently taking a flaxseed supplement
* Currently engaged in vigorous exercise training
Safety, Efficacy Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.

This is a multi-center, open-label, single-arm trial to evaluate the efficacy and safety of Recombinant Coagulation Factor VIII in patients with hemophilia A . Recombinant Coagulation Factor VIII is prophylactic administrated 25 - 35 IU/kg once every other day or three times per week which should be continuous for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Hemophilia A.
2. FVIII:C \<1%. 3）12 and 65 years old.

4）Has received FVIII treatment and the treatment exposure days ≥100. 5）Has bleeding treatment records of at least 3 months before randomization. 6）FVIII inhibitor assay results is negative. 7） Subjects should agree to use an adequate method of contraception during the study.

8）Understood and Signed an informed consent form.

Exclusion Criteria:

1. Has a history or family history of blood coagulation factor VIII inhibitor.
2. Has other coagulation dysfunction diseases in addition to hemophilia A.
3. HIV positive.
4. Plan to receive surgery during the trial.
5. Has used immunomodulator within one weeks before the first dose，and less than 7 half-life periods.
6. Known to be allergic to experimental drugs or any excipients.
7. Severe anemia and need blood transfusion.
8. Serious liver or kidney damage.
9. Serious heart disease.
10. Uncontrollable hypertension.
11. Has participated in other clinical studies within one month before the first dose.
12. The researchers believe that it is not suitable for participants.
Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)

This research is being done to test the effectiveness of an early intervention model for very young children at high risk for autism spectrum disorders (ASD) and their families. If children show improvement in this intervention, the investigators hope that the availability of public services of this type will be increased. Children between 11 months and 21 months old with Autism Spectrum Disorders, or with social and communication delays that indicate high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment must start prior to the second birthday.


Eligibility Criteria:
Inclusion Criteria:

* Children will be ascertained between 11 months and 21 months of age
* Must be able to enter the study prior to their second birthday
* Must then pass an eligibility assessment to determine whether the child meets criteria for ASD and thus qualifies for the study. This assessment will consist of the Baby ADOS and the Mullen Scales of Early Learning. Children must meet criteria for ASD or autism on the ADOS, score more than one standard deviation below the mean on the Receptive or Expressive Language scale of the MSEL, and have a clinical judgment of ASD to be eligible for enrollment into treatment.
* Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
* The parent (or other primary caregiver, such as grandparent) in the Parent Enrichment/Training condition must agree to attend the training sessions

Exclusion Criteria:

* Fail hearing or vision screening (by pediatrician's office, audiologist, or ophthalmologist)
* Family's first language being other than English (language measures are normed on English speakers, putting non-English speakers at a disadvantage. In addition, the treatment is delivered in English. Children from non-English speaking homes may not make progress, but for reasons other than the efficacy of the intervention.)
* Head injury (because this may cause some of the symptoms, which may not be due to autism and therefore we would not be able to assess the effects of the intervention on autism)
* Identified reason for the autism (e.g., fragile X syndrome, Rett syndrome, Tuberous Sclerosis)
* Inability of the family to attend the playgroup sessions and parent trainings
* Parents whose hearing or vision is not within normal limits after correction (e.g., hearing aid, glasses)
* Parents with developmental delays, language or learning impairments, or a psychiatric diagnosis IF the impairment would interfere with parent training (PI will assess on a case by case basis by talking to the parent)
* Foster children
* Refusal to allow videotaping of the children's assessments or intervention or to allow videotaped footage to be used for teaching purposes.
Validation of a Food Addiction Screening Test

Food addiction (FA) is a behavioral addiction characterized by a high consumption of palatable foods, which markedly activate the reward system, despite adverse consequences. FA was first described in 1956 but remains controversial. The Yale Food Addiction Scale (YFAS), developed by Gearhardt et al. in 2009, is currently regarded as the "Gold Standard" for FA screening. In a previous study, we established a Food Addiction Screening Test using artificial intelligence. The main objective of the present study is to validate the sensitivity, specificity and precision for FA diagnosis in a sample of patient suffering from obesity and healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30
* Able to consent

Exclusion Criteria:

* Non-french speaker
* Patient unable to use internet tools
PermeaDerm® vs. Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds

The purpose of this study is to compare the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds: PermeaDerm® (PermeaDerm, Inc., Carlsbad, California, USA) and silver impregnated foam dressing (Mepilex Ag®, Health Care, Göteborg, Sweden)

In this prospective, randomized parallel study, the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds will be compared: PermeaDerm®, and silver coated foam dressing Mepilex Ag®.This study is therefore considered a minimal risk study. Procedures related to research apart from randomization to one of the dressings, will include review of medical records, non-invasive wound and scar assessments and additional photographs.

60 patients with partial thickness burns meeting the inclusion criteria of the study will be enrolled to receive either PermeaDerm® (n=30) or silver coated foam dressing (Mepilex Ag®; n=30) in an outpatient or observational setting.

Prior to placement of wound dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Time to heal will be defined as the time after which complete re-epithelialization is reached and PermeaDerm® detaches or there are no more changes of Mepilex Ag® needed. Secondary goals of the study are to assess pain, and scarring associated with the use of the different dressings in our burn patients, as well as to assess cost-effectiveness of the therapy.

Pain will be assessed at every patient visit using visual analog scale (VAS) or Wong-Baker FACES respectively; mid and long-term scar development is assessed at approximately 1 and 6 months after enrollment in the study using Patient and Observer Scar Assessment Scale (POSAS) and DermaLab Combo® (Cortex Technology, Denmark).

Eligibility Criteria:
Inclusion Criteria:

* Superficial partial thickness burn injury due to flame burn, scald injury or contact burn that does not require excision and grafting
* Total Body Surface Area burned (TBSA) total ≤30 %
* Admission within 72 hours of burn injury
* Non-infected wound as diagnosed by the attending physician upon admission
* Treated as an outpatient or in an observational setting

Exclusion Criteria:

* Patient younger than 6 months
* Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
* Admission time greater than 72 hours after the injury
* Wounds noted to be infected at admission
* Previous treatment efforts such as previous debridement, silver sulfadiazine ointment or other pseudo eschar-forming topical agents
* Pregnancy/lactation
Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma

This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).

This study aimed to compare the overall survival and progression free survival between 6 cycles and 12 cycles adjuvant Temozolomide regimens in patients with brain glioblastoma and anaplastic astrocytoma. The main inclusion criterion includes patients newly diagnosed with glioblastoma and anaplastic astrocytoma whose diagnosis is confirmed by histologic evaluation. The main exclusion criteria involve chronic renal, hepatic or cardiac failure. The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage). This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1). This study will be conducted in the oncology clinic of Omid Hospital and Imam Reza Hospital, Mashhad. Blinding is not observed in this study. The primary endpoints of study are overall survival and progression free survival.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed glioblastoma and anaplastic astrocytoma
* age between 18 and 70 years
* Karnofsky Performance Scale Index equal or more than 60 percent
* signed informed consent

Exclusion Criteria:

* chronic hepatic
* renal failure
* cardiac failure
* history of hematologic malignancies
Treatment of Sleep Disturbances in Trauma-affected Refugees

The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.

BACKGROUND:

Sleep disturbances are often referred to as a hallmark of PTSD. In a sample of 734 trauma-affected refugees undergoing psychiatric treatment at Competence Centre for Transcultural Psychiatry (CTP) in the period 2008-2012 99% reported sleep disturbances and nightmares.

In trauma-affected populations untreated sleep disturbances can uphold and exacerbate both sleep-related and non-sleep-related PTSD symptoms. Sleep disturbances may also affect the efficacy of first-line PTSD treatment and constitute a risk factor for poor outcome of psychiatric treatment. It has been argued that effective treatment of sleep disturbances may accelerate recovery in PTSD. There is a lack of randomised clinical trials on this relation in trauma-affected refugees.

The aim of this study is to examine sleep enhancing treatment in refugees with PTSD.

MATERIALS AND METHOD:

The study will include 230 refugees, diagnosed with PTSD, referred to CTP. Patients who give informed consent will be randomised to four treatment groups.

1. Treatment as usual (TAU); pharmacological treatment according to algorithm and manual based Cognitive Behavioural Therapy
2. TAU and add-on treatment with mianserin
3. TAU and add-on treatment with Imagery Rehearsal Therapy (IRT)
4. TAU and add-on treatment with mianserin and IRT

RESULTS:

This study is expected to bring forward new knowledge on both medical and therapeutic treatment of sleep disturbances in trauma-affected refugees.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* Refugees or persons who have been family reunified with a refugee
* PTSD pursuant to the International Classification of Diseases ICD-10 research criteria
* Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nation definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.
* Sleep disturbances/ PSQI \>8
* Nightmares/ HTQ score on nightmare item ≥ "a little"
* Signed informed consent

Exclusion Criteria:

* Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Patients are excluded only if the psychotic-like experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression
* Current abuse of drugs or alcohol (F1x.24-F1x.26)
* Known neurodegenerative disorder (Alzheimer's disease (AD), Parkinson's disease (PD), Levy-Body dementia (LBD))
* In need of admission to psychiatric hospital
* Pregnant and breastfeeding women and women of the reproductive age who wish to conceive during the project period.
* Allergy towards active ingredients or excipients in mianserin
* Lack of informed consent
Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery

In cardiac operations under cardiopulmonary bypass(CPB), monitoring of brain tissue oxygen saturation with infrared spectrophotoscopy leads to a reduction of the number of packed red cell(PRC) transfusions during the period of extracorporeal circulation.

The purpose of this study is to investigate whether the use of brain tissue oxygen saturation monitoring will lead to a reduction of the intra-operative use of packed red cell units.

Patients randomly allocated to groups A and B. In group A INVOS monitoring available. In group B, no access to INVOS for the attending anesthesiologist. An "observer" anesthesiologist has access to INVOS and provides information if it is considered necessary.

For BOTH GROUPS:

During CBP and before aortic unclamping, PRC not to be given if hemoglobin is \>7g/dl. For values less than 5.5g/dl, one unit of PRC is transfused and the patient is reevaluated. After weaning from CPB and retransfusion of the salvaged shed blood, transfusion when hemoglobin is \<8g/dl. During ICU stay, transfusion when hemoglobin is \<8g/dl. Between 8-10g/dl evaluation for transfusion in a multimodal manner.

For GROUP A:

As above and during CBP and before aortic unclamping, if hemoglobin is between 5.5-7g/dl, transfusion when INVOS is less than 60%.

For GROUP B:

As above and during CBP and before aortic unclamping, if hemoglobin is between 5.5-7g/dl, decision for transfusion is taken by the attending anesthesiologist (judgment).

Eligibility Criteria:
Inclusion Criteria:

* Cardiac operations under cardiopulmonary bypass, consequently (including coronary-aortic bypass graft), valve replacement, surgery of the ascending aorta, combined procedures, redo-operations)

Exclusion Criteria:

* Cardiac operations without the aid of extracorporeal circulation (ex. "off-pump" techniques)
* Emergency operations
22-G-Procore Needle for the Diagnosis of SETs of the Upper GI Tract

The goal of this prospective study is to evaluate the feasibility of the 22-G Core Biopsy Needle with reverse bevel (Procore TM) in biopsy sampling of subepithelial tumors of the upper gastrointestinal tract.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age 18 years and older
2. All patients with subepithelial tumors of the upper GI tract (maximum size: 3 cm)

Exclusion Criteria:

1. Unable to obtain informed consent
2. ASA class 4 or 5
3. known pregnancy
4. contraindication endoscopy
5. contraindication for taking biopsies
Initiation of Insulin Aspart in Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate if using insulin aspart as start therapy will improve the efficacy on daytime blood glucose cycle profile in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 3 years
* HbA1c greater than 8.0%
* Body Mass Index (BMI) below 40.0 kg/m2
* Inadequate treatment with diet and OADs
* Never received treatment with insulin

Exclusion Criteria:

* Type 1 diabetes
* Known or suspected allergy to investigational product
Effect of Usage of Electroencephalogram (EEG) Entropy on the Incidence of Postoperative Cognitive Dysfunction in Geriatric Patients

To determine if the usage of EEG Entropy helps to reduces the incidence of POCD in elderly patients after general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II.
* scheduled for retinal surgery expected to take 2-3 hours under general anesthesia.
* orotracheal intubation.

Exclusion Criteria:

* history of cardiac, pulmonary, liver or renal disease.
* significant obesity (body mass index \>30.
* Long-term user of central nervous system activator drugs, benzodiazepines and/or opiates.
* dementia, brain atrophy and other neurological disorder.