cyrilzakka/clinical-trials huggingface dataset:
Retrospective Cohort Study Of The Efficacy Of Axona® (Medium Chain Triglycerides) In Patients With Alzheimer's Disease

This evaluation of the efficacy and safety of AXONA will be a chart review carried out at 16 practices in which AXONA has been prescribed for the treatment of patients with mild-to-moderate AD. Efficacy of AXONA will be assessed by comparison of patient status before and after initiation of treatment.

The primary objective is to assess the efficacy of AXONA (medium chain triglycerides \[MCTs\]) when used alone or in combination with other agents in patients with mild-to-moderate Alzheimer's disease (AD) in routine clinical practice.

Eligibility Criteria:
Patient Inclusion Criteria:

* Male or female outpatients aged ≥ 50 years with a diagnosis of probable AD of mild-to-moderate severity
* MMSE score between 14 and 24 inclusive at the initiation of AXONA treatment (if available)
* Has received Axona for a duration of ≥ 6 months

Caregiver Inclusion Criteria (if applicable):

* Must be at least 21 years of age, has been the primary caregiver since prior to the initiation of Axona, provides at least 4 hours of supervision or direct assistance per day for the patient and is able to perform assessments.

Patient Exclusion Criteria:

* MMSE score \< 14 at the time when AXONA treatment was initiated
* Presence of co-morbid disease known to adversely impact cognitive function (e.g., Parkinson's disease, history of cerebral infarcts, dementia with Lewy bodies)
* Vascular dementia
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma

The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years, gender is not limited;
2. Patients with lymphoma diagnosed by histopathology or cytology;
3. Patients requiring multi-cycle chemotherapy;
4. Planned chemotherapy regimen FN risk ≥ 20 % , or 10% \<FN risk \< 20% with high risk factors ; According to the judgment of the investigator, there is a risk of FN occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used prophylactically from the first cycle;
5. Physical status (KPS) score ≥ 70 points;
6. Expected Survival period of more than 3 months;
7. Normal bone marrow hematopoietic function (ANC ≥1.5×10\^9/L, PLT≥80×10\^9/L, Hb≥75g/L, WBC≥3.0×10\^9/L);
8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; total bilirubin (TBIL)≤2.5 times the upper limit of normal value; serum creatinine (Cr)≤2 times the upper limit of normal value;
9. Female patients of childbearing age must be negative in urine pregnancy test before treatment;
10. The testers (or their legal representatives/guardians) must sign an informed consent form.

Exclusion Criteria:

1. Lymphoma central involvement;
2. Hematopoietic stem cell transplantation or organ transplantation;
3. Local or systemic infection without adequate control;
4. Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
5. Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen；
6. Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
7. Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
8. Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
9. Researchers determine unsuited to participate in this trial.
GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes

Life-style change achieved in controlled experimental condition has been shown to prevent type 2 diabetes. The purpose of this study is to evaluate to what extent the life-style change can be achieved in a routine health care setting.

The GOAL (Good Ageing in Lahti region) Program Life-style change implementation trial to prevent type 2 diabetes was set to examine and enhance the effectiveness of life-style change counselling in the primary health care. In the intervention, specific nutritional, physical activity and weight loss objectives shown effective in diabetes prevention in an earlier randomised controlled trial are used as a benchmark, embedded in a structured group counselling model with an empowerment-oriented approach and adapted into the primary health care setting. In the trial, effectiveness and process are evaluated, the analyses including gender and socio-economic differences. Participants were 361 middle-aged (50-65 yrs) adults at an increased risk for type 2 diabetes, recruited in 16 primary health care centres in Paijat-Hame, Finland. Intervention and data collection took place in year 2003.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes risk test score \> 11 (Lindstrom \& Tuomilehto, 2003)

Exclusion Criteria:

* mental health problem or substance abuse likely to interfere with participation
* acute cancer
* type 2 diabetes requiring pharmacological treatment
* myocardial infarction during the past six months
Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia

This is a prospective, multicentre observational study screening all adult patients admitted to a participating hospital over a 6-month study period (may be adjusted to 4-8 months according to recruitment) and including all patients with suspicion of or confirmed acute mesenteric ischaemia (AMI).

Only admission data and hospital mortality outcome will be collected for patients in whom suspicion of AMI is not confirmed. For patients with confirmed AMI full data collection regarding diagnostics, management and long-term outcome is required.

Investigators aim to recruit 40-50 sites with expected median of 10-20 patients with confirmed AMI per site during the study period (naturally depending on the size of the hospital). The start of the study is planned for Spring 2022.

The aim of the study is to identify the incidence of AMI and its different forms in adult hospitalized patients, and to describe patient characteristics (demographic, clinical and laboratory) at baseline, applied diagnostics and management, as well as outcomes in patients with AMI. An additional aim is to compare the baseline characteristics and outcomes of patients with confirmed AMI to those of patients with suspected AMI in whom the diagnosis was not confirmed.


Eligibility Criteria:
Inclusion Criteria:

All patients with suspected AMI

Exclusion Criteria:

Age \<18 years Consent declined by patient or next of kin Chronic mesenteric ischaemia without an acute event
Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity

Aim of the study is to improve the diagnosis of food allergy and hypersensitivity. Intestinal homogenates will be used to determine total IgE, specific IgE, tryptase, histamine and inflammation parameters (IFNgamma, TNFalpha). These data will be correlated with serum values and disease status. In addition, organoids from duodenal tissue will be isolated and cultured in vitro and stimulated with the major food allergens. The gene and protein expression will be checked to identify relevant biomarkers.

Food intolerances (FI) show an increasing prevalence and represent a particular challenge in clinical practice. The symptoms of a predominantly gastrointestinally mediated food allergy (FA) are similar to the symptoms of other FI (e.g. carbohydrate malabsorption, gluten sensitivity, histamine intolerance, irritable bowel syndrome), so that diagnosis is difficult and often delayed.

Well-evaluated methods for the clarification of an allergic disease are serological screening (IgE against food products or other cross-reacting allergens) and skin prick tests. However, these methodes have their limitations in the diagnosis of seronegative or mainly gastrointestinal-mediated FI. Patients often associate the consumption of certain foods with the clinical symptoms, which often leads to strict self-imposed elimination diets, but rarely to the correct identification of the triggering food.

In a pilot study, the investigators showed that patients with gastrointestinal FI have elevated mucosal IgE levels and TNF using homogenates from intestinal biopsies. Another patient subgroup could be identified that showed low allergic parameters (low mucosal IgE, low TNF) but high mucosal interferon levels, indicating a non-specific inflammation.

In this study, mucosal IgE, tryptase, histamine, IL4, and inflammatory parameters (e.g. TNF, IFN) from different areas of the gastrointestinal tract will be determined in a larger collective. Furthermore, organoids are cultured in vitro from duodenal tissue samples, incubated with blood cells and stimulated with food allergens. The titres of specific IgE from the mucosal homogenates will be correlated with serum levels and organoid stimulation results to identify relevant biomarkers. Microbiome and metabolome analyses will provide information about the intestinal flora in FI.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* patients with suspected food allergy or hypersensitivity
* healthy controls with indications for endoscopic diagnostics, e.g. tumour history within the family, exclusion of gastritis

Exclusion Criteria:

* pregnant person
A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.

This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Histologically or cytologically documented unresectable, locally advanced or metastatic breast cancer or gastric cancer refractory to standard therapy.

   1. For subjects with breast cancer:

      * Prior treatment with trastuzumab, pertuzumab, and T-DM1, either alone or in combination, is required.
      * Subjects with a primary tumor that is hormone (estrogen, progesterone, or both) receptor-positive or receptor-negative are eligible.
      * Prior hormone therapy is allowed, but last dose must be at least 14 days prior to first dose of MEDI4276.
   2. For subjects with gastric cancer:

      * Prior treatment with a trastuzumab containing chemotherapy regimen is required.
3. HER2 Positive disease documented as FISH-positive and/or 3+ by IHC on previously collected tumor tissue.
4. At least one lesion measurable by RECIST Version 1.1.

Exclusion Criteria:

1. Receipt of any conventional or investigational anticancer treatment within 28 days prior to the first dose of MEDI4276.
2. History of exposure to the following cumulative doses of anthracyclines:

   1. Doxorubicin or liposomal doxorubicin \>350 mg/m².
   2. Epirubicin \>530 mg/m².
   3. Mitoxantrone \>90 mg/m² and idarubicin \> 70 mg/m².
   4. If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 350 mg/m² of doxorubicin.
3. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery or other therapy to control symptoms from brain metastases within 2 months prior to first dose of MEDI4276.
Comparison of Fetal Thymus Volumes of Pregnant Women With In Vitro Fertilization (IVF) and Spontaneous Pregnant Women.

The purpose of the study was to compare the fetal thymus volumes of 18-24-week pregnant women with In Vitro Fertilization (IVF) and spontaneous pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* pregnant between 18-24 weeks
* had no complaints
* between the ages of 18-35
* conceived with in vitro fertilization or spontaneously

Exclusion Criteria:

* history of endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease, and congenital adrenal hyperplasia), systemic diseases (e.g. asthma), collagen disorder, hypercholesterolemia, sickle cell anemia, or neoplasm,
* those who had a history of coronary artery disease, angina, or myocardial infarction, or a history of hypertension, coronary arteritis, and electrocardiographic changes that suggest any known history of vascular, infectious, or inflammatory disease, maternal autoimmune disease,
* use of any drugs other than those used for IVF (e.g. insulin sensitizing drugs, oral contraceptives, antiandrogens, statins, aspirin, and corticosteroids) in the 3 months before the pregnancy,
* multiple pregnancy,
* present cigarette and alcohol use,
* abnormal renal, hepatic, and thyroid function test results;
* refusing to participate in the study,
* abnormal fetal findings (fetal anomaly, increased nape transparency, first-second trimester screening test disorder),
* cases who did not meet the criteria for pregnancy after the first tube treatment (ICSI-ET) because of normoresponder, unexplained infertility, or male factor
Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial

AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients receiving surgical therapy due to anal HPV infection.

Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical Imiquimod-therapy). It is planned to include 200 patients.

100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive surgical therapy + topical Placebo therapy


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign and date a written consent document
* Male and female patients \>= 18 years of age
* Negative urine/serum pregnancy test
* Indication for surgical therapy of anal HPV lesions

Exclusion Criteria:

* Participation in another clinical study with experimental therapy
* Diagnosis and therapy of HPV associated lesions in the last 12 months
* Known intolerance of hypersensitivity to Imiquimod
* Women who are pregnant of lactating
Human Perception of Odors and Odor Blockers

The goal of this clinical trial is to determine whether blockers of perception of key odorants in cigarette smoke have any utility in smoking cessation. The main question it aims to answer is:

• Can odor blockers be used to suppress perception of the intensity of cigarette smoke in ways that reduce the ability of the odor of cigarette smoke to increase the urge to smoke.

Participants will be asked to smell up to 20 odor samples per session and report on odor pleasantness and desire to smoke.

The experimental treatments include controls (clean air, irrelevant odor), blocking odors, cigarette smoke odor, and cigarette smoke odor mixed with blocking odors or irrelevant odor. To obtain cigarette smoke odor a 1 inch length of a 1R6F research cigarette is burned to completion in a sealed 5 gallon chamber fitted with septa. Using a syringe fit with a needle and filter, 60 mL aliquots of smoke odor are obtained. These smoke odor aliquots, along with blocking odors, are injected into odor sample bags fit with a septum and a valve that can be attached to the CPAP nose mask worn by each participating smoker. Participants open the valve, inhale once through the nose, close the valve, and then remove the bag from the mask before reporting odor pleasantness and the desire to smoke. A 2 - 3 min wait period is enforced between each odor presentation to prevent odor adaptation and to allow acute motivational effects to subside.

In a testing session a participant sniffs 4 concentrations of a mixture of 2 blocking odors, along with control odor samples. Presentation order is randomized. Each participant is assigned their own CPAP nose mask, and masks are disinfected after use. Participants also provide demographic (age, sex, ethnic and racial background) and smoking history information (cigarettes per day, preferred brand, age at onset, and time since last cigarette).

Eligibility Criteria:
Inclusion Criteria:

* Smoker

Exclusion Criteria:

* Non Smoker
* Self reported inability to smell or taste
Implementing a School-based Mindfulness Curriculum

The outcomes and implementation processes of the school based mindfulness program, as a universal prevention program in classroom as and support group programs for students with special education needs will be investigated. The study of classroom program will apply quasi-experimental design, comparing the pretest and posttest of seven primary schools with implementation of mindfulness programs with three schools with ordinary school activities only. A total of 800 students will be recruited to receive an eight session mindfulness program in classroom as a universal prevention program. Ten support group for students with special education needs will apply mindfulness programs, and its outcome will be evaluated using repeated time measures.


Eligibility Criteria:
Inclusion Criteria:

* students in participating schools
* students with parent's consent

Exclusion Criteria:

* student without parent's consent
Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)

This study aims to examine the efficacy of a brain-computer interface system for the treatment of inattentive symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The investigators hypothesis is that children with ADHD receiving treatment with the BCI-based training will improve to a greater extent than the control group.

Additionally, the investigators are also conducting an fMRI study involving interested participants, to elucidate the neural mechanisms underlying any behavioural improvement. This is necessary to help the investigators gain a better picture of brain correlates related to ADHD and understand how the intervention can affect the brain.

This BCI study will involve 2 phases. The first phase is a preliminary study to test the safety and effectiveness of the novel BCI device which involves newly developed dry electrode sensors and intervention game. Twenty children, aged 6-12 and diagnosed with Inattentive or Combined subtype of ADHD will be recruited for the study. This open-label, experimental arm will go through 8 weeks of BCI intervention.

The second phase will be a randomized controlled trial involving 160 children. They will be randomized into the treatment or control arm. The treatment arm will receive 8 weeks of BCI intervention, similar to the experimental arm. The other group will serve as wait-list controls.

The fMRI trial aims to examine the underlying neural processes explaining any therapeutic effects that may be seen.

The study will enroll 70 children with ADHD, aged 6-12, who are participating in the main randomized controlled trial: 40 from the BrainpalTM intervention group and 30 from the control group; participants will undergo fMRI scan at Week 0 and 8 or Week 8 and 16. The study will recruit another 30 children aged 6-12 from the community as the healthy control group, who will undergo the same imaging procedure once. The scans will involve both functional and structural imaging.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV-TR criteria for ADHD, either the combined or inattentive subtype, based on the Diagnostic Interview Schedule for Children (CDISC; Schaffer et al., 2000)

Exclusion Criteria:

* Present or history of medical treatment with stimulant medication and Atomoxetine
* Co-morbid severe psychiatric condition or known sensori-neural deficit e.g. complete blindness or deafness (such that they cannot play computer games)
* History of epileptic seizures
* Known Developmental Delay (i.e. IQ 70 and below)
* Predominantly Hyperactive/impulsive subtype of ADHD (i.e. no predominant inattentive symptoms)
* Present/history polyunsaturated fatty acids supplement intake (e.g. Omega-3 oil, flax seed oil, cod liver oil) in the past 3 months
* Present/history of traditional Chinese medicine (TCM) prescribed for treatment of attention problems in the past 1 month
Incisional Hernia Repair by Abdominal Wall Component Release With Contemporary Onlay Mesh Fixation

There is a great expansion in the presentation of complex incisional hernia defects. Primary closure for most cases is impossible with a high rate of recurrence. Component separation provides an autologous repair of the defect but still has considerable recurrence rate. Reinforcement of component separation provides a more strength full repair and may be less recurrence.

the surgical correction was done under general anesthesia. After scrubbing and draping, an elliptical incision was performed .

Open the hernia sac then reduce the contents with adhesolysis as required. subcutaneous flaps on both sides were created in a manner that permit to spread an 8 cm mesh after the closure of the abdominal wall. approximate the facia after trimming of its edges with clamps with a manner that allow 1to 2 cm overlap in the midline without tension.

In case of tension do selective myofascial advancement (sequential components release). Our steps would be first a unilateral posterior rectus sheath release (1-2 cm longuitodinal incision lateral to linea alba) and reassess, if tension still present, bilateral posterior sheath release should be performed.If tension still present, do a unilateral then bilateral external oblique release as required (1-2 cm lateral to the linea semilunaris along the length of the abdominal wall).

close the defect with prolene 1 then cover with onlay wide pore mesh fixation with 2/0 prolene. Close the skin after placement of 2 subcutaneous suction drains.

Eligibility Criteria:
Inclusion Criteria:

* Age of 16 years and older.
* Both sexes.
* Patients with clean incisional hernia of stage I, II and III according to the ventral hernia staging system were included.

Exclusion Criteria:

* - Obese patients with BMI ≥35 kg/m2, Patients with contaminated hernia stage II and III, patients with collagen disease, patients with history of aortobifemoral bypass, Patients refusing mesh hernioplasty, Females in childbearing age who looks for further children, Patients unfit for surgery according to ASA criteria, Patients with a parastomal hernia, patient with a stoma and patients with uncontrolled diabetics, active smokers, and patients with COPD were excluded