cyrilzakka/clinical-trials huggingface dataset:
Different Clinicopathological Features of Non-Elderly Sigmoid Volvulus Patients

Sigmoid volvulus is frequently seen in male patients over 60 years old. In the sigmoid volvulus \<60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in \<60 age groups, it is more likely to be another underlying organic pathology.

Sigmoid volvulus is frequently seen in male patients over 60 years old. Here, the investigators aimed to investigate the causes of sigmoid volvulus developing in patients under 60 years of age. Patients diagnosed with sigmoid volvulus between 2009 and 2018 were retrospectively screened. The patients were divided into two as under 60 years old and above. The co-morbidity, mortality, morbidity, complications, age and gender data of the patients were analyzed. In the sigmoid volvulus \<60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in \<60 age groups, it is more likely to be another underlying organic pathology.

Eligibility Criteria:
Inclusion Criteria:

* Sigmoid volvulus patients under the age of 60
* Sigmoid volvulus patients at the age of ≥60

Exclusion Criteria:

* Lack of data
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada

This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Patients in Canada.

Data will be collected via web-based data capture and paper surveys depending on patient preference. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have received Fibristal within 6 months of completing the survey.
* Patients who have provided permission to share their responses in aggregate with Health Canada.
* Patients who have provided informed consent for their participation in the survey.

Exclusion Criteria:

* Patients who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.
* Patients who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past year.
Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy \> 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.


Eligibility Criteria:
Inclusion Criteria:

* Person who undergo gastroduodenoscopy
* Person who visit Konyang University Hospital

Exclusion Criteria:

* Bleeding diathesis
* History of stomach neoplasms
* History of upper gastrointestinal surgery
Pre-operative Studies for Prediction of Lymph Nodes Involvement in Endometrial Cancer Patients

The study evaluates pre-operative prediction of the risk for lymph nodes involvement in endometrial cancer patients. Patients will undergo ultrasound exam (bi and three dimensional) and biomarker test - Ca 125, in addition to routine physical and laboratory exams, before surgery.

The sonographic evaluation will include endometrial characteristics and myometrial invasion, pelvic findings and enlarged lymph nodes.


Eligibility Criteria:
Inclusion Criteria:

* Endometrial cancer patients
* Surgical candidates

Exclusion Criteria:

* Fertility preservation therapy
* Contraindication for surgery
* Stage 2 and higher
A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome

The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation reflecting the current knowledge about the disease, Heart Rate Variability Coherence Biofeedback, pacing and activity planning and some principles of cognitive behaviour therapy. The study is designed as a Single-Case study including 10- 15 participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants who meet the diagnostic criteria of chronic fatigue syndrome
* Clinically evaluated, exclude any disease that can explain the chronic fatigue;
* Diagnosed and evaluated within the health region, Central Norway
* With written consent form signed by themselves and their parents.

Exclusion Criteria:

* serious comorbidity such as anorexia, psychosis
* serious depression
PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer

This is prospective, multicenter, randomised phase III trial among women with endometrial cancer with high-intermediate risk features to investigate the role of an integrated clinicopathological and molecular risk profile to determine if participants should receive no adjuvant therapy, vaginal brachytherapy or external beam radiotherapy based on a favourable, intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.

Adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinically relevant reduction of the risk of relapse by the adjuvant treatment. Risk profiles have traditionally been based on clinicopathological factors such as age, stage, grade, LVSI and depth of invasion. Newer, both molecular-genetic (the cancer genome atlas subgroups) or immunohistochemistry-based (L1-CAM) risk factors have become available which are strongly related to outcomes and risk of cancer spread. In a comprehensive analysis of the PORTEC-1 and-2 biobank an integrated clinicopathological and molecular risk profile was determined which separated the current high-intermediate risk group of endometrial cancer in 3 separate groups (favourable, intermediate or unfavourable) with clearly separated outcomes, which is now prospectively tested in the clinic to determine adjuvant treatment. This is the first randomised trial using the molecular risk factors to assign adjuvant treatment for women with stage I-II high-intermediate risk endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of the following combinations of stage, grade, age, and lymph-vascular space invasion (LVSI):

  1. Stage IA, grade 3 (any age, with or without LVSI)
  2. Stage IB, grade 1 or 2 and age \>60 years
  3. Stage IB, grade 1-2 with documented LVSI
  4. Stage IB, grade 3 without LVSI
  5. Stage II (microscopic), grade 1
* World Health Organization (WHO)-performance status 0-2
* Written informed consent

Exclusion Criteria:

* Any other stage and type of endometrial carcinoma
* Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
* Uterine sarcoma (including carcinosarcoma)
* Previous malignancy (except for non-melanomatous skin cancer) \< 5 yrs
* Previous pelvic radiotherapy
* Expected interval between the operation and start of radiotherapy exceeding 8 weeks
MOS Prebiotic Potential in Older Adults

Mannooligosaccharides (MOS) derived from baker's yeast may have prebiotic properties such as improving gastrointestinal function. The aims of this study are to determine the effect of MOS on gastrointestinal function and symptoms and fecal microbiota in older adults.

Novel prebiotics with specific microbiome targets and without adverse gastrointestinal symptoms are needed for the exploration of health benefits. This is a 3-week, open-label pilot study designed to evaluate the effect of 15 g per day of yeast-derived mannooligosaccharides on gastrointestinal symptoms, stool frequency, fecal microbiome, and urinary metabolites.

Eligibility Criteria:
Inclusion Criteria:

* Adults 50-99 years of age.
* Able to provide written informed consent in English.
* Willingness to complete all study procedures
* Healthy or diagnoses with Parkinson's or multiple system atrophy

Exclusion Criteria:

* Yeast allergy.
* Self-reported kidney disease.
* Elite athletes or long-distance runners.
* Use of antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of the screening visit.
* Current use of laxatives or antidiarrheal medications.
* Use of other investigational products within 3 months of the screening visit.
* Previously or currently being treated for any intestinal disease or condition, including IBS, Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer (self-report).
* Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection)
* Current cancer treatment
* Currently pregnant
Satiety Effects of Pulses Compared to Matched Protein Smoothie

The satiety effects of pulses compared to a matched smoothie will be measured.

The investigators will compare satiety and food intake after consumption of purses or a calorie/protein matched smoothie

Eligibility Criteria:
Inclusion Criteria:

* healthy, normal body weight,

Exclusion Criteria:

* smoker, restrained eating habits, recent weight change, history of disease, vegetarian, do not normally eat breakfast or lunch, are pregnant or lactating, have irregular menstrual cycles
Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

We propose to examine several angiogenic/angiostatic mediators in the skin and serum of subjects with SSc and compare it to levels found in the skin and serum of healthy subjects.

Systemic sclerosis (SSc) is a connective tissue disease that is characterized by fibrosis of the skin and internal organs. One of the earliest pathologic changes in patients with SSc is damage to the blood vessels. Many abnormalities have been found in the inner layer of the blood vessel, the enothelial tissue. It is known that there are mediators in the blood and tissues of the body that affect the endothelial tissue. These are called angiogenic (promote blood vessel formation) and angiostatic (inhibit blood vessel formation) mediators. Many of these mediators have been examined in the peripheral blood of patients with SSc, but fewer of these mediators have been examined at the site of action, in the tissue near the microvasculature. We hypothesize that there are differences in the levels of angiogenic/angiostatic mediators between healthy subjects and subjects with SSc. In addition, we propose that there are differences at skin sites that have varying levels of involvement with SSc of these angiogenic/angiostatic factors in subjects with SSc.

Eligibility Criteria:
Inclusion Criteria:

1. Meet American College of Rheumatology criteria for systemic sclerosis
2. Subjects with systemic sclerosis must have involvement proximal to the knee or elbow, excluding the face
3. Persons with no chronic health conditions

Exclusion Criteria:

1. Persons with systemic sclerosis as a result of being exposed to chemicals or drugs that can cause a sceroderma-like illness
2. Persons with autoimmune diseases other than systemic sclerosis
3. Persons treated with cyclophosphamide in the last 8 weeks
4. Persons with active infections, including but not limited to hepatitis C, hepatitis B, and HIV
5. Persons prone to bleeding because they are treated with medications that thin the blood or have a low platelet count
Genetic Association Study Between GAD1 and Reelin Polymorphisms and GABA/Glutamate MRS in Bipolar Disorder Type 1 and Healthy Controls: SPECGENE PROJECT

Background: The pathophysiological mechanisms of bipolar disorder are not completely clarified and several hypothesis have already been formulated including the role of monoamines, gama amino butyric acid (GABA) and glutamate. GABA is the main inhibitory neurotransmitter while glutamate is the main excitatory neurotransmitter. Genes that play a role in GABA metabolism and in the activity of GABA neurons are very important to understand the GABA function, once they affect neurodevelopment and its dysfunctions may predispose to neuropsychiatric diseases. The two genes that are going to be study in this project are glutamic acid decarboxylase (GAD1) and reelin (Reln). The enzyme glutamic acid descarboxylase (GAD67) metabolizes glutamate in GABA in the pre synaptic neuronal regions and is coded by the gene GAD1. Reelin is secretory serine protease with dual roles in mammalian brain: embryologically, it guides neurons and radial glial cells to their corrected positions in the developing brain; in adult brain, Reelin is involved in a signaling pathway which underlies neurotransmission, memory formation and synaptic plasticity. Magnetic resonance spectroscopy (MRS) studies on bipolar disorder show a number of alterations in cerebral level of GABA and glutamate in different cerebral areas when compared to healthy subjects and other mood disorders. Objective: Investigate in bipolar patients and healthy controls the association of GAD1 and Reln single nucleotide polymorphisms(SNP) and cerebral levels of GABA/glutamate on MRS. Methods: 70 symptomatic bipolar I patients medication free and 70 healthy controls are going to be genotyped for GAD1 and Reln SNPs and GABA/glutamate MRS.

Key words: GAD1, GAD67, bipolar, GABA, Glutamate, Reelin, Rln, Spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Bipolar disorder type I diagnose (DSM-IV criteria)
* Medication free (4 last weeks)

Exclusion Criteria:

* heavy smokers
* cannabis use
* recent alcohol abuse (14 days)
THERMARTHROSE: Gonarthrosis and Water Cure

The main objective of this study is to evaluate the therapeutic effect of a thermal treatment on gonarthrosis, with an increase of the number of patients presenting a clinically significant improvement.

Gonarthrosis is a frequent pathology and the prevalence increase with age (prevalence: 6,1% in an adult population more than 30 years old and 40% after 75 years). It has a large impact on the quotidian life of the patients and it cause important costs for social protection. Relative to the treatment, numerous recommendations have been proposed (EULAR, ACR specifically). But no one of them recommends thermal treatment even if it is largely used in Europe and especially in France for the treatment of this pathology. Several prospective controlled randomized studies have evaluated the effect of the thermal treatments in rheumatology and some of them are relative, in part, to Gonarthrosis. So, we conduct a phase III randomized, controlled, single blind study evaluating the therapeutic effect at 6 month of a thermal cure on gonarthrosis.

In a situation of physical treatment, it's impossible to use a placebo as control: blind can't be respected. Whatever the methodology employed, non blind of the patient create a bias. So, we hope that the Zelen method for randomization will reduce the bias due to the dissatisfaction of the patients in the control group.

Eligibility Criteria:
Inclusion Criteria:

* ACR criteria: knee pain and one of the tree following conditions: Age \> 50 years, Morning stiffness\< 30 minutes and articular crackling.
* osteophytes visible on knee radiography.
* knee radiography less than 3 years old: face, schuss, axial of kneecap cliché.
* Actual gonarthrosis intensity on Visual Analogic Scale \> or = 30mm.

Exclusion Criteria:

* arthrosis limited to the femoro-patellar compartments.
* severe depressive syndrome, psychosis.
* Thermal cure less than 6 month before.
* Contra-indication or predictable inability to tolerate thermal cure.
* Profession lied to hydrotherapy.
* previous knee treatments:

  * massage, physiotherapy and acupuncture since less than 1 month;
  * infiltration since less than 3 months;
  * NSAI since less than 5 days;
  * analgesic since less than 12 hours;
  * modification in the medicinal anti-arthrosis treatment since less than 3 months.
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event

This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).

Brief resolved unexplained events (BRUE) are frightening episodes characterized by the appearance of life-threatening choking, pallor, cyanosis, and limpness in infants. These common events are resource-intensive and current management approaches inadequately address persistent symptoms. Infants with BRUE commonly have oropharyngeal dysphagia with aspiration, which is a modifiable risk factor for persistent symptoms, but there are no studies determining the mechanism behind this swallowing dysfunction and if swallowing interventions reduce morbidity. This is a prospective, longitudinal cohort study of infants who experienced brief resolved unexplained event receiving thickened feedings compared to those not receiving thickened feedings over 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Less than 1 year of age
* Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.

Exclusion Criteria:

* Any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease
* Already receiving thickened liquids for treatment of another condition
Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming

This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during operation. Half of patients will be anesthetized using manual TIVA and other half using TCI.

Awareness is possible in TIVA in case of technical failure or prolonged induction phase, TCI technology seems to prevent these events. Total of 80 patients planed for elective neurosurgical brain tumor resection fulfilling the inclusion criteria will be devided into two groups. First half will be anesthetized using TIVA with manual induction and the second half will be anesthetized using TCI. All patients will fulfil Modified Brice Questionnaire one hour after the end of operation.

Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma scale 15
* ASA Physical Status Classification System I - III
* planed surgery for brain tumor to 5 hours
* postoperative awakening

Exclusion Criteria:

* NYHA III, IV
* abuse of stimulating drugs, grass, alcohol dependence
* BMI over 40 in females and over 35 in men
* propofol alergie
* awake operations
* postoperative arteficial ventilation
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

Visit 1 (Screening Visit)

* Be willing and able to comply with all treatment and follow-up/study procedures.
* Be a candidate for routine, uncomplicated cataract surgery.

Visit 3 (Postoperative Day 1)

* Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens (IOL) implantation, not combined with any other surgery) in the study eye.
* Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion Criteria:

* Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
* Have known hypersensitivity or contraindication to the study drug(s) or their components.
A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.

This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed/Refractory non-Hodgkin's lymphoma to determine if ARV-393 may be a possible treatment option.

ARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth. This is the first time ARV-393 will be used by people. The investigational drug will be given as an oral tablet.

This is an open-label, multicenter, phase 1, dose escalation study to evaluate the safety, tolerability and preliminary anti-tumor activity of ARV-393 as a single agent in adult patients with relapsed/refractory non-Hodgkin lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants aged ≥18 years.
* Have relapsed/refractory mature B-cell non-Hodgkin lymphoma (NHL) and ≥2 prior systemic therapies, or histologically confirmed AITL that has recurred or progressed following institutional standard-of-care therapy.
* Participants must also have ≥1 measurable lesion at study entry
* Eastern Cooperative Oncology Group performance status of 0 or 1,
* Freshly biopsied or archival tumor tissue available,
* Participants with adequate organ function,
* Participants must accept and follow pregnancy prevention guidance.

Exclusion Criteria:

* No prior allogeneic stem cell transplant or solid organ transplantation, Autologous stem cell transplant, must not have occurred ≤100 days, previous CAR T-cell therapy ≤60 days, radiotherapy ≤ 2 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, prior to ARV-393 treatment initiation.
* Participants must not have significant acute or chronic medical illness, including hypereosinophilic syndrome, active interstitial lung disease or pneumonitis, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
* Participants with an inability to comply with listed prohibited treatments.