cyrilzakka/clinical-trials huggingface dataset:
Colon Cancer Prognosis After Radical Surgery

1. Radical surgery. It is supposed to improve prognosis of colon cancer. A surrogate measure of achievement of radical surgery is the number of lymph nodes removed with the specimen.
2. Markers. There may be variables that may make patient assessment more sound. The project is including investigation of such markers (genes, old age, comorbidity, and others).
3. Laparoscopic resections. This is being used more and more in cancer surgery but the feasibility of this approach remains to be proven compared with conventional open surgery. The project compares these according to 1) and 2).
4. Morbidity and mortality must be surveilled to keep at a minimum. Many patients have comorbidity and are old to make this factor extra important, including perioperative care.
5. Proper treatment of colon metastases may prolong life. Treatment of lung-metastases will be studied in particular.

1. Radical surgery. A detailed description of procedures for each location of tumor in the large intestine is used. By following a given procedure for each location in the large intestine, the number of lymph nodes can be analyzed for each location to find out if this differs and if prognosis is affected by lymph node numbers according to tumor site.
2. Markers. Different variables are examined for use in clinical judgment to make treatment better as well as genetic experimental analyses for comparison with clinical outcome to better understanding of clinical behavior.
3. Laparoscopic resections. The technical challenge of laparoscopic approach has been compared with conventional surgery without any difference being observed in trials. However, it should be compared with radical open surgery to compare best achievements by using number of lymph nodes as well as outcome measures in the short and long term (mortality).
4. Comorbidity, old age itself, type of surgery and perioperative care according to the so called fast track surgery may all play a part in reducing perioperative morbidity and mortality. A maximum 3% mortality should be aimed for.
5. Colon cancer usually metastasize to the liver and lungs. Surgical treatment of liver metastases has been extensively studied and the prognosis has improved. Lung metastases has not been given similar attention but the prognosis of those operated may be good and equal that after liver surgery. The need for pulmonary resection and factors associated with metastases and lung metastases in particular will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Malignant tumor (adenocarcinoma) of the large intestine (colon)
* Willingness to participate

Exclusion Criteria:

* No radical resection (R0) possible
* Unwilling to participate or medically unfit to undergo follow-up
A Fast, Quiet, Artificial Intelligence-based PET/MR Solution for Paediatric Diseases

To investigate the feasibility of deep learning-assisted rapid silent PET/MR in pediatric applications.

This study aims to address the challenges faced by PET/MR in pediatric applications by leveraging new technologies such as flexible coils, silent sequences, and deep learning-based image reconstruction. The objective is to provide a rapid, silent, comfortable, and half-dose PET/MR imaging solution for pediatric patients, and to demonstrate its feasibility in this patient population.

Eligibility Criteria:
Inclusion Criteria:

1. Children who have clinical symptoms and are suspected of having malignant tumors after being evaluated by clinical pediatricians and require 18F-FDG PET/MR examination to further clarify their conditions.
2. Signed and dated informed consent form
3. Commit to complying with the research procedures and cooperate in the implementation of the entire research process.
4. No gender restriction, aged between 0 and 18 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Patients with severe claustrophobia，epileptic seizures, respiratory distress who cannot lie down, and patients with mental anomalies who are unable to cooperate.
3. Patients with metal implants such as pacemakers, artificial metal heart valves, and neurostimulators in their bodies.
4. Non-compliant person.
Sertindole in Asian Patients With Schizophrenia

The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia.

This study is the first randomised clinical trial performed in Asia with sertindole, aiming at comparing sertindole efficacy and safety to that of another atypical antipsychotic.

Sertindole is a limbic-selective antipsychotic agent with a unique neuropharmacological profile. Sertindole has shown significant improvements relative to placebo against both positive and negative symptoms of schizophrenia (measured by PANSS total, PANSS negative and positive subscale scores). It is well tolerated and shows placebo-level incidence of extrapyramidal symptoms (EPS). Sertindole is associated with a dose-dependent increase in the QT interval, but this does not translate into an excess mortality with sertindole relative to that of other recently developed antipsychotics in their respective clinical development programmes.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia
* Positive and Negative Syndrome Scales (PANSS) total score between 60 and 120 (extremes included) at screening and baseline
* Based on the patient's clinical status, an antipsychotic treatment is indicated
* Otherwise healthy
* Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods

Exclusion Criteria:

* Current Axis I primary psychiatric diagnosis other than schizophrenia
* Has never before received antipsychotic drugs
* Has received a depot antipsychotic medication within less than one dose interval prior to Screening
* History of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (\<50 beats per minute)
* Congenital long QT syndrome or a family history of this disease, or in patients with known acquired QT interval prolongation (QTc above 450 msec in males and 470 msec in females at Screening)
* Significant risk of suicide and/or violent behaviour
* Known history of narrow angle glaucoma
* Substance or alcohol abuse, current alcohol dependence
* Use of disallowed concomitant medication

Other protocol-defined inclusion and exclusion criteria may apply.
Exteriorization Versus Non-exteriorization of the Uterus During Repair of Uterine Incision in a Repeated Cesarean Section

Cesarean section is one of the most frequently performed major operations worldwide. It accounts for between 1% and 70% of deliveries depending on the facilities or country assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut university is 51.3% of all deliveries.

Different Operational techniques For cesarean section have been defined aimed at reducing surgical time, making the surgery easier and more efficient, lowering costs,decreasing the risk of adverse effects and postoperative morbidity, as well as length of hospital stay.

Also, Intraoperative blood loss is one of important complications during cesarean section. A systematic review included twenty one studies, in 2011, revealed that increase incidence of intraoperative blood loss and blood transfusion with increase number of cesarean deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant women about 51% of pregnant women.

After baby born by cesarean section and the placenta has been extracted, uterine incision is sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal cavity (in situ repair). There had been few randomized controlled trials comparing intraoperative and postoperative morbidity following exteriorization of the uterus with non-exteriorization. The conclusions drawn from these trials have been conflicting.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in 28 weeks
* Women who will undergo repeated lower segment cesarean section

Exclusion Criteria:

* First cesarean section
* Placenta previa.
* Rupture uterus.
* Classical caesarean section.(upper segment cesarean section)
* Sever Preeclampsia.
* Chorioamnionitis.
* prolonged or obstructed labour.
* Fibroid.
* Polyhydramnios.
* Multiple pregnancy.
Duration of Red Blood Cell Storage Prior to Transfusion

This study will determine the minimal duration of red blood cell (RBC) storage that leads to increases in circulating non-transferrin-bound iron in healthy human volunteers post-transfusion. The results from this study will help guide national guidelines for appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food and Drug Administration (FDA) criteria. The overall objective of this research is to improve the safety of refrigerated storage of red blood cells before transfusion.

Recent studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Red cells may be stored in a refrigerator prior to transfusion for up to 42 days by current FDA standards. Refrigerator storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased delivery of hemoglobin-iron to certain parts of the body. The investigators have preliminary data in mice and humans suggesting that delivery of a significant iron load from aged red cells leads to the production of a potentially toxic form of circulating iron called non-transferrin-bound iron.

In this prospective study of healthy volunteers, each subject will be randomized to receive transfusion of one RBC unit after 1, 2, 3, 4, 5, or 6 weeks of storage. The primary outcome will be the 24 hr area under the curve (AUC) of the serum non-transferrin bound iron concentration calculated from samples collected at 0, 2, 4, 6, 8, 10, 12, 14 and 24 hours after transfusion.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Body weight \>110 lbs
* Hemoglobin \>12.5 g/dL

Exclusion Criteria:

* Ineligible for donation based on the New York Blood Center blood donor questionnaire
* Systolic blood pressure \>180 or \<90 mm Hg, diastolic blood pressure \>100 or \<50 mm Hg
* Heart rate \<50 or \>100
* Temperature \>99.5 F prior to donation
* Temperature \>100.4 F or subjective feeling of illness prior to transfusion (this is to avoid having a concurrent illness affect post-transfusion measurements);
* Positive results on standard blood donor infectious disease testing
* Positive urine pregnancy test
Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water.

To conduct a randomized, double-blinded, placebo-controlled, cross-over trial in a population of chronically, moderately dehydrated people comparing two waters on hydration status.

A randomized, double-blinded, placebo-controlled cross-over study design will be used to evaluate the effects of consumption of alkaline water against reverse osmosis water. The study is of 5 weeks' duration, with evaluation at baseline, 2 weeks (beginning of wash-out period), 3 weeks (end of wash-out period), and 5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adult people of either gender;
* Age 18 - 65 years (inclusive);
* BMI between 18.0 and 34.9 (inclusive);
* Screening results showing at least one of the following:

  * Hematocrit: Women: 45.0 or higher; Men: 48.7 or higher;
  * BUN/Creatinine ratio 20 or higher;
  * Sodium levels 146 mmol/L or higher;
  * Potassium levels 5.3 mmol/L or higher;
  * Chloride levels 108 mmol/L or higher.
* Willing to maintain a consistent diet (including medications, vitamins and supplements) and lifestyle routine throughout the study;
* Willing to abstain from coffee, tea, soft drinks, and nicotine for at least one hour prior to a clinic visit;
* Willing to abstain from alcohol for at least 12 hours prior to a clinic visit;
* Willing to maintain a consistent habit of abstaining from exercising and nutritional supplements on the morning of a study visit.

Exclusion Criteria:

* Cancer during past 12 months;
* Chemotherapy during past 12 months;
* Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure).
* Previous major surgery to stomach or intestines \[(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal\];
* Implanted electronic device such as pacemaker or implantable cardioverter-defibrillator (ICD);
* Currently experiencing peripheral edema in legs and /or feet;
* Diagnosed with any blood clotting disorder or taking clotting factor concentrates;
* Diagnosis of Peripheral Artery Disease;
* Diagnosis of varicose veins;
* Currently taking blood pressure medication;
* Currently taking blood thinning medication (81mg aspirin allowed);
* Currently taking diuretic medication;
* Currently taking nutritional supplements and other substances judged by the study coordinator to negate or camouflage the effects of the test product;
* Women who are pregnant, nursing, or trying to become pregnant.
Quality of Life in Thai Women Diagnosed Cervical Cancer at King Chulalongkorn Memorial Hospital

To study the quality of life of patients earlier diagnosed for cervical cancer and cervical intraepithelial neoplasia (CIN).

In Thailand, age standardized incidence is 20.9 per 100,000 women-year. Treatment-related survival gain are experienced by side-effect that may reduce quality of life (QoL). We therefore, study the quality of life of patients earlier diagnosed for cervical cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Thai patients
* aged more than 15 years old.
* Diagnosed of cervical intraepithelial neoplasia (CIN) or cervical cancer with pathological confirmation. If she has more than one diseases, the most severe will be considered as diagnosis.
* Not suffered from confusion or reduced level of consciousness or unable to communicate.

Exclusion Criteria:
Dermatologists' Educational Demonstration for Epiduo Application

The purpose of this study is to evaluate the efficacy and tolerability of this combination gel compared with BPO monotherapy in Korean patients, and test clinical practicability of dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable irritations.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate acne were evaluated by Leeds revised acne grade from 2 to 6
* age: 18-40

Exclusion Criteria:

* pregnancy
* mental illness
* intake of oral isotretinoin within 6 months
* application of the other oral or topical acne medications
* chemical peeling or light based treatments within 6 weeks.
Effects of Different Anesthetic Gases on Hemodynamics, Arterial Oxygenation and Lung Mechanics

The bronchodilator effects of volatile anesthetics have been the subject of many clinical studies. It is known that all volatile anesthetics, especially halothane, have similar effects. Sevoflurane has been shown to reduce airway resistance more than halothane and isoflurane. Desflurane is difficult to use as an induction agent due to its harsh and extremely pungent odor and airway irritating effect. However, it has been shown that the risk of cough, respiratory arrest and laryngospasm is no different from sevoflurane when administered after intravenous induction. Although it irritates the airway, it is thought to have a bronchodilation effect as it stimulates the sympathetic system.

In spinal surgeries, prone position is required to access the operating field. When the patient is placed in the prone position, pulmonary physiology are affected. In the prone position, V/Q mismatch decreases and arterial oxygenation increases. However, lung compliance decreases and the peak inspiratory pressure required to reach the required tidal volume increases. The main purpose of this study is the effect of volatile agents on lung mechanics and oxygenisation in the prone position.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* ASA1-2
* Patients planned to undergo spinal surgery

Exclusion Criteria:

* 1 - Lung disease
* BMI 35 and above
* Smokers
* Those under the age of 18 and over the age of 65
* Hepatorenal disease
* Reynaud's disease
* Burger disease
* Hypotensive patient
* Neuromuscular disease
* Those who have had thoracic surgery before
* Those with bad Allen test results
Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine

Single centre, open-label, randomised study in four parallel groups of healthy volunteers

Single centre, open-label, randomised study in four parallel groups of healthy volunteers: Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine; Group 3 = 450 mg of S-licarbazepine; Group 4 = 450 mg of Rlicarbazepine. In each group, the study consisted of a single-dose period (Phase A) followed by a repeateddose period of 7 days of duration in which the investigational product was administered once daily (Phase B). The repeated-dose phase started 96 h post single-dose.

Eligibility Criteria:
Inclusion Criteria

* Male or female subjects aged between 18 and 45 years, inclusive.
* Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
* Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
* Subjects who had clinical laboratory tests clinically acceptable at screening and admission.
* Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
* Subjects who were negative for drugs of abuse and alcohol at screening and admission.
* Subjects who were non-smokers or who smoke \< 10 cigarettes or equivalent per day.
* Subjects who are able and willing to give written informed consent.
* (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
* (If female) She had a negative pregnancy test at screening and admission to Phase A.

Exclusion Criteria:

* Subjects who did not conform to the above inclusion criteria, OR
* Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
* Subjects who had a clinically relevant surgical history.
* Subjects who had a clinically relevant family history.
* Subjects who had a history of relevant atopy.
* Subjects who had a history of relevant drug hypersensitivity (especially carbamazepine or oxcarbazepine).
* Subjects who had a history of alcoholism or drug abuse.
* Subjects who consumed more than 14 units of alcohol a week.
* Subjects who had a significant infection or known inflammatory process on screening or admission.
Predictors for Successful Neurofeedback Training

The primary objective of this study is to identify predictors of neurofeedback training success.

In the last decades, neurofeedback has been established as a promising scientific tool. Learning voluntary control over their own brain activity allows for establishing causal links between brain activity and mental functions. However, patients participants differ in their ability to learn control over their own brain activity with neurofeedback. It is thus crucial to understand why some participants are more successful in regulating their own brain activity than others. The objective of the present study is thus to identify predictors for successful learning self-regulation with real-time fMRI neurofeedback. To achieve this goal, we will evaluate the introspection ability of healthy participants using standardized psychological questionnaires and tasks. These scores will then be correlated with how well they learned self-regulation skills using established real-time fMRI neurofeedback protocols.

Eligibility Criteria:
Inclusion Criteria:

Age 18 - 65 years. Magnetic resonance imaging compatibility.

Exclusion Criteria:

Physical or psychiatric disorders (DSM-V diagnosis). Current substance abuse. Exclusion criteria applicable to MRI (metallic implants, claustrophobia, epilepsy).
SweMaMi DMI, Microbiome

Dysbiosis is associated with an increased risk of preeclampsia during pregnancy. The microbiome differs between those with and without type 1 diabetes and the cause of type 1 diabetes has been associated with dysbiosis. Increased knowledge of the microbiome and its variation, depending on the state of health during pregnancies complicated with type 1 diabetes, could in the future lead to preventive care and treatments during these pregnancies.

Prospective cohort. All women with type 1 diabetes that are planning a pregnancy and being cared for at the diabetic ward at Södersjukhuset will be asked to participate, n= 55.

All pregnancies complicated with type 1 diabetes that are being cared for at the special maternity ward at Södersjukhuset, n=45.

The expected to include is 100. Expected viable pregnancies: 50.

The maternal vaginal, fecal and oral microbiome will be sampled by "self-sampling" at home before, during and after the pregnancy, by this schedule:

1. Inclusion, before pregnancy after an appointment with the diabetic doctor or nurse. Or at the first visit at the special maternity care ward during pregnancy (around gestational week 8).
2. When the pregnancy is first discovered if the inclusion were before pregnancy.
3. Week 28.
4. When attending delivery ward in labor
5. 6-10 weeks postpartum from both the mother and the new-born. The tests will be sent to the obstetric research center at Södersjukhuset, where the tests will be saved in freezes. The analysis will be performed at CTMR at the Karolinska Institute.

Background, pregnancy and delivery data will then be associated with the woman microbiome in the vagina, in feces and in saliva.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women with type 1 diabetes
* Included as a patient at women's clinic Soderhospital in Stockholm
* Acceptant to sample her microbiome during pregnancy

Exclusion Criteria:

* Women without type 1 diabetes