cyrilzakka/clinical-trials huggingface dataset:
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI

The purpose of this study is to investigate how gut hormones and brain areas respond differently to gastric distention, tasteless calories, or palatable food and how this alters appetite.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-25 kg/m\^2.
* Weight stable for 3 months prior to study entry.
* For females: study days will be scheduled during the follicular phase of their menstrual cycle (i.e., the first 13 days (about 2 weeks) of the cycle).
* Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures..
* Ability to perform light to moderate physical activity.

Exclusion Criteria:

* Any contraindication for MRI scanning.
* Any history of childhood (\> 95th percentile) or adult obesity (BMI \>30 kg/m\^2).
* Claustrophobia.
* High intensity training or physical activity.
* Any contraindication for intragastric balloon insertion.
* Any allergies to the study meals.
* Any history of eating disorder.
* Any substance abuse disorder (including alcohol and tobacco).
* Any history of psychiatric disorders.
* Any cardiovascular, endocrine, pulmonary, neurological, or gastrointestinal comorbidities.
* Pregnancy or nursing.
* Any history of bariatric surgery or endoscopic bariatric procedure.
* Use of any medication or supplement that alters appetite.
* Patient has a known history of any condition or factor judged by the investigator to prevent participation in the study or which might hinder study adherence.
Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

Rationale: The construction of esophageal anastomoses is associated with considerable risk at postoperative anastomotic leakage. Application of TachoSil®, a tissue sealant with human fibrinogen and thrombin, can improve strength of the esophageal anastomosis and potentially prevent anastomotic leakage.

Objective: Evaluation of feasibility and safety of TachoSil® application on esophageal anastomoses.

Study design: Non-randomized, non-blinded, single-center intervention study. Study population: Patients, 18-80 years old, undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis will be enrolled. A total number of 15 patients will be included in the study.

Intervention: Gastric or esophageal resection will be executed according to the common procedures used in the UMC Utrecht. After construction of the esophageal anastomosis, all enrolled participants will receive a TachoSil® patch, which will be applied on the esophageal anastomosis intra-operatively. Hence, TachoSil® is used as an add-on therapy. TachoSil® will be degraded enzymatically in a period of approximately 24 weeks after application.

Main study parameters/endpoints: The primary endpoint is feasibility, which is assessed by evaluation of adherence of the patch. A time-action analysis of the application of the Tachosil patch will be performed.

Nature and extent of the burden associated with participation: The burden for the patient is minimal. The total surgical procedure will be prolonged with 10-15 minutes. Postoperative care and outpatient visits do not differ from regular protocol. TachoSil® is approved and registered for supportive treatment in surgery for improvement of haemostasis and to promote tissue sealing by the European Commission.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis
* Male and female gender
* Ages 18-80
* Signed informed consent
* For females of childbearing potential:

  * Patient uses a reliable contraceptive method: contraceptive pill, intrauterine device, subdermal implantation, or transdermal patch
  * Patient has a negative serum or urine pregnancy test.

Exclusion Criteria:

* Emergency resections of esophagus of stomach
* Unsigned informed consent
* History of hypersensitivity reactions to human fibrinogen, human thrombin, or collagen.
* Patients having difficulty understanding Dutch and English
* Mentally incapable patients
* Pregnancy or breast feeding
The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide

Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and trendelenburg position which result in oxidative stress and inflammatory response.

Propofol is well known to reduce those responses during anesthesia. Therefore, we try to figure out the efficacy of propofol to reduce oxidative stress, inflammatory response and increase the nitric oxide activity during robot-LRP compared to that of desflurane.

To investigate the oxidative stress, malondialdehyde will be measured. As inflammatory markers, interleukin-1β, interleukin-6, tumor necrosis factor-α will be measured. Nitric oxide will be measured as well.

Secondarily, kidney protection effect of propofol over desflurane will be compared.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia

Exclusion Criteria:

* chronic renal failure ( estimated glomerular filtration rate \<60 mL/min/1.73m2)
* allergy to propofol, nuts
* on diuretics, vitamin C or vitamin E within 5 days before surgery
* Body mass index \> 30 kg/m2
* older than 70 years
* who cannot read the patient consent form
Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients

In recent years, the patients with IB2 and IIA2 stage cervical cancer are still treated with radiotherapy and chemotherapy based treatment, but the radiotherapy will severely damage the function of ovary, cause endocrine dyscrasia and the sexual function of vagina. So we want to study whether neoadjuvant chemotherapy without radiotherapy will achieve the same outcome compared with traditional therapy including radiotherapy. So we randomly divide IB2 and IIA2 stage cervical cancer patients into two groups. The neoadjuvant chemotherapy group will receive two courses of chemotherapy basically composed of platinum, and then undergo surgery, after that, doctors will add more courses of chemotherapy according to the situations of the patients, including whether the patients have the adverse prognostic factors. The control group will undergo surgery directly, and then receive chemotherapy and radiotherapy at the same time. Then we will compare the outcomes of these two groups, and analyze the therapeutic effect, the impact on survival rate and the effect on improving the living quality of patient from two groups. All the outcomes will be fed back to clinical doctors and instruct them to choose better treatment for patients.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis IB2 or IIA2 stage cervical cancer;
* age less than or equal to 65 years old;
* laboratory examination results: WBC ≥ 4\*10\^9/L, NEU ≥ 20\*10\^9/L, PLT ≥ 80\*10\^9/L, serum bilirubin ≤ 2 multiples of the upper normal limit, aminopherase ≤ 2 multiples of the upper normal limit. BUN ≤ normal limit, CR ≤ normal limit;
* KARNOFSKY score ≥ 60;
* No prior treatment;
* pathological diagnosis before surgery is invasive squamous cell carcinoma of cervix;
* well-compliance and willing to keep in touch;
* willing to participate in this study, and sign the informed consent;

Exclusion Criteria:

* participate in other drug clinical trials at the same time;
* respiratory depression, airway obstruction and hypoxia;
* heart diseases (cardiac function at grade II, III or above);
* hematological diseases;
* obvious dysfunction of liver and kidney (above 3 multiples of the upper normal limit);
* a history of brain dysfunction;
* unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
* drug abuse or a history of drug abuse;
* unable or unwilling to sign informed consents;
* unable or unwilling to follow the protocols;
Effects of E-cigarette Flavors on Youth TCORS 2.0

This study is an examination of the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth.

Researchers will examine the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth. Participants will rate the flavor intensity, coolness, sweetness, and irritation experienced using validated rating scales. Forty youth (18-20 years of age) who have experience with e-cigarettes and will participate in 1 laboratory session. They will receive 1 nicotine concentrations (36mg/ml nicotine salt) during the session; during the session they will be exposed, in random order, to sweet (watermelon) and sweet-cooling (watermelon-menthol) flavors combined with the assigned session nicotine concentration.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-20 years
* Able to read and write
* Used e-cigs at least 10 times in lifetime
* Used e-cigs in past 30 days

Exclusion Criteria:

* Current use of non-prescription substances besides nicotine, marijuana, alcohol
* Any significant current medical or psychiatric condition
* Known hypersensitivity to propylene glycol
* Pregnant or lactating females
* Uncontrolled asthma
* Nut/e-liquid flavorant allergy
* current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms
Social Media Chatbot on Physical Activity Education for Older Adults

In this study, a social media chatbot was used to provide a continuous and real-time multimedia health education program on physical activity for the older adults, as well as supportive messages and feedbacks, to improve physical activity and exercise self-efficacy among the older adults. This study was a cluster randomized trial, and participants were recruited from community care stations and activity centers in Taipei City. The experimental group was involved in an 8-week, 5-day-a-week intervention with a total of 40 multimedia physical activity education programs, and users were provided with real-time feedback interactions and regular physical activity education guidelines, and self-administered questionnaires were used for data collection. The research instruments include basic personal information, International Physical Activity Questionnaire, Exercise Self-Efficacy Scale, Behavioral regulation in exercise questionnaire-2, Exercise Benefits/Barriers Scale, and the statistical methods will be descriptive statistics, independent sample t-test, paired sample t-test, and one-way analysis of covariance.


Eligibility Criteria:
Inclusion Criteria:

1. Persons aged 60 to 85 years old living in Taipei City, healthy or with chronic conditions
2. Those who can listen, read and write Chinese
3. Those who have used smartphones in the past month and can use Line social software
4. Those who voluntarily participate in this study, can understand the research content after explanation and explanation, and sign the subject consent form

Exclusion Criteria:

1. Those who are advised by a doctor not to exercise
2. Those who must exercise under the supervision of medical personnel
3. Patients with severe cardiovascular disease
4. Anyone with disability or cognitive impairment
5. Persons living in long-term care institutions
Depressive Symptoms in Acute Manic Episode

Observational, non-interventional, transversal, multicenter, open label (No treatment is involved). The primary objective is to detect the prevalence of depressive symptoms in bipolar patients admitted to a psychiatric Unit due to an acute mania episode. Secondary objectives include 1) to evaluate, the relationship between depressive symptoms and severity of mania; 2) to evaluate, the relationship between depressive symptoms and anxiety; 3) to evaluate, the relationship between depressive symptoms and psychotic symptoms; 4) to evaluate, the relationship between depressive symptoms and insight; 5) to evaluate, the relationship between depressive symptoms and clinical global impression; 6) to evaluate, the relationship between depressive symptoms and previous treatment with antipsychotics (whatever the antipsychotic was); 7) to evaluate, the relationship between depressive symptoms and length of admission; 8) to evaluate factors (demographic, evolution...) which could be involved in the presence of depressive symptoms within an acute manic episode; 9) to evaluate, the difference on the initial prescription due to the detection of depressive symptoms; 10) to evaluate, if exists, differences on the previous psychiatric diagnosis in patients with and without depressive symptoms. The primary endpoint is score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed of Bipolar Disorder based on DSM-IV-TR
* Patients admitted to an acute inpatient psychiatric Unit due to an acute manic episode (as defined in DSM-IV_TR)
* Provision of written informed consent.
* Total score in Young Mania Rating Scale \>=20
* Able to understand and comply with the requirements of the study

Exclusion Criteria:

* Mental retardation
* Patients with manic symptoms are due to substance use, based in the investigator opinion
* Patients with unstable organic diseases, who are not receiving adequate treatment, according the investigator opinion.
* Participation in a trial with drugs within 4 weeks of enrolment into this study.
SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.

The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Italy in reducing their care-giving burden.

This intervention is going to take a form of an Internet-based Intervention (IBI) consisting of eight therapeutic modules. These are the themes, as listed chronologically: Introduction, Thoughts and Acceptance, Problem Solving, Stress and relaxation, Communication, Behavioural Activation, Worry and Anxiety, Maintenance. These themes were chosen after considering topics which might be the most useful for someone in a role of an informal caregiver, considering the trans-diagnostic nature of the intervention.

Effect of the intervention will be compared against a wait-list control group. Intervention is in Italian.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or over and both gender;
2. spent at least the last couple of months providing care;
3. must have internet access and the ability to use a computer or any other compatible device;
4. must be able to complete a phone interview -

Exclusion Criteria:

1) having severe physical or mental impairments, psychiatric conditions or neurological disorders; 2) the person in need of care has a life expectancy below or approximately around 6 months; 3) not able to use a computer or an electronic device; 4) not able to complete a phone interview;

-
A Randomized, Control Trial for Preinduction Cervical Ripening

The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.


Eligibility Criteria:
Inclusion Criteria:

* Women that are hospitalized for induction of labor that have a Bishop's score \<5
* singleton gestation
* cephalic presentation
* 24 weeks gestational age

Exclusion Criteria:

* Prior uterine surgery
* malpresentation
* placenta previa or abruption
* clinically suspected or diagnosed intra amniotic infection
* genital HSV infection
* multiple gestation
* premature rupture of the membranes
* active labor
* maternal/fetal conditions that may preclude labor induction in the opinion of the investigators
HILO-HF Registry: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure

The HILO-HF Registry is a single centre registry that will be performed to provide information on the usual baseline oxygen saturation (SpO2) in patients presenting to ED with a primary ED diagnosis of AHF


Eligibility Criteria:
Inclusion Criteria:

* Patients \>40 years of age presenting to the ED with AHF
* With or without tested BNP
* With or without admission to hospital for treatment of HF\\
* Patients must be recruited within the first 24 hours of presenting to the ED.

Exclusion Criteria:

* Patients on home oxygen
* Patients with known prior hypercapnic failure (PaCO2\>50 mmHg)
* Asthma
* Primary pulmonary hypertension
* Patients requiring urgent positive pressure ventilation or intubation or on \>10 L/min oxygen
Effect of Probiotics on Oral Homeostasis During Sugar Stress

The present study is a double-blinded randomized clinical trial with a duration of 28 days.

The present study is a double-blinded randomized clinical trial with a duration of 28 days.

80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is sugar stress, which will be applied at baseline and continue through day 14, followed by 14 days without sugar stress.

Clinical measurements and sampling will be performed at baseline, day 14 and day 28

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 yrs.

Exclusion Criteria:

* Presence of oral diseases i.e. gingivitis, periodontitis and dental caries
* Current smokers
* Any systemic diseases and current use of any medication with known effect on oral health
* Use of systemic antibiotics within the latest three months.
* Age \< 18 yrs., and age \> 30 yrs.
Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

The tympanic membrane separates the middle and the outer ear from each other and consists of three layers. The outer layer is covered with squamous epithelium, a thick basement membrane in the middle and an inner Mucosal layer. Rupture of the tympanic membrane is common cause of hearing loss.

In spite of the ability to spontaneously healing of the tympanic membrane, chronic tear of the eardrum in the absence of its spontaneously healing indicates surgical management. These surgeries are performing using various materials including fascia, cartilage, fats, pericardium and paper patch. It has proven that using different materials results in outcome and postoperative complications. The criteria of the best graft material includes availability, preservability, manageability, and acceptance rate to the hosts. Human amniotic membrane is preservable. Also, there isn't significant immunologic reactions against such graft material. So, choosing the best graft for Tympanoplasty surgery decreases complications, hospitalizations after surgery, and costs, consequently.

Up to now, limited studies have been conducted on the patients who were used amniotic membrane in the surgical reconstruction. There are different outcomes and complications which depend on the size of the rupture and the problems associated with the surgical conditions.

Considering that it can reduce the surgical time and cost of surgery, and with its high success rate, it can even be used as a substitute for conventional methods. The aim of this study was to compare the result of surgical repair of the tympanic membrane using membrane amniotic and surgical Tympanoplasty with Autologous fascia. Here the investigators reported on 30 patients who underwent Typmanoplasty with amniotic membrane and Temporalis fascia grafting.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Acute Otorrhea / - Cholesteatomas / - Canal stenosis requiring Canaloplasty / - Immunosuppressive patients / - Active neoplasm / - Diabetes Mellitus / - Ruptures less than one fifth of the eardrum / - Smoking.
Efficacy of a Natural Ingredient on Blood Pressure

Randomized controlled trial with two parallel branches (experimental product and placebo), double blind and unicentric with which it is intended to evaluate the efficacy of the product under investigation against placebo on blood pressure of normotensive subjects or with hypertension grade I without Pharmacotherapy. The subjects that meet the selection criteria will make a total of five visits to the research laboratory and perform the tests that were pre-established in the protocol. Later, a statistical analysis will be carried out with the variables measured in the study to obtain results.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes between 18-65 years old.
* Systolic blood pressure between 120 and 159 mmHg or diastolic blood pressure between 80 and 100 mm Hg. taken in basal conditions.
* Volunteers able to understand the clinical study and willing to comply with the procedures and requirements of the study

Exclusion Criteria:

* In pharmacological treatment of arterial hypertension.
* Subjects with acute diseases.
* Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathological conditions or malignant tumor disease that can modify the blood pressure of subjects.
* Subjected to major surgery in the last 3 months.
* Subjects who stopped smoking in the last 6 months or who intend to quit during the study.
* Subjects with allergies or eating disorders.
* Participation in another study that includes blood extractions or dietary intervention.
* Pregnant woman.
* Subjects whose condition does not make them eligible for the study, according to the researcher.
Study of Lupron Depot In The Treatment of Central Precocious Puberty

The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued.

This study includes a Prestudy Period; a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for females); a follow-up period where subjects will be observed every 6 months until physical and laboratory observations are at pubertal levels, then every 12 months for 5 years; lastly a final follow-up questionnaire is given to all subjects when they are at least 18 years old.

At the treatment visits, efficacy assessments are Tanner staging (suppression of breast development in females and genital development in males), gonadotropins (LH and FSH), sex steroids (estradiol in females and testosterone in males), ratio of bone age to chronological age, adult height compared to a standard population and predicted mature height, and age and time to regular menses in females. This protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II for pubic hair or genitalia earlier than 9.0 years in boys.
* Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone (GnRH) stimulation test (LH \> 10 U/L at baseline).
* Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time of first dosing.
* Bone age advanced at least 1 year beyond the chronological age at entry into the study.
* The condition may be idiopathic or secondary to another lesion. If secondary, therapy of the primary condition will have been undertaken and stabilized.
* No evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for premature secretion of gonadotropins.

Exclusion Criteria:

* Irradiation to the central nervous system.
* Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).