cyrilzakka/clinical-trials huggingface dataset:
A Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis

The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. The subject should have the pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.

This trial contributes to save the time for decreasing primary tumor in rectal and metastasis cancer to whole body after short course radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Subject whom should have the pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.
* Over 18 years
* ECOG 0-1
* Proper organ function (hepatic transaminases : \< ULN ⅹ5, Bilirubin: \< ULNⅹ2, creatinine (serum): \< ULNⅹ 1.5, PLT \> 100,000Ul, ANC \> 1,500/Ul
* more than one target lesion (standard by RECIST 1.0)
* Who should sign on the Informed consent form before participate the trial.

Exclusion Criteria:

* Metastasis in other organ except liver (No matter whether have resection or not)
* Chronic active hepatitis or cirrhosis
* History of treatment for colorectal cancer
* Subject pregnant or breast feeding
* Uncontrolled disease (eg. infection, hypertension, heart failure, Myocardial Infarction within 6months)
* Have been used FOLFOX as an adjuvant therapy
* Have had adjuvant therapy within 6months
* Uncontrolled peripheral nerve infection
* Alcoholic or drug addict
* Subject currently is enrolled in or ≤30 days from ending other clinical trial.
* History of other type of cancer except resolved from skin cancer and cervical cancer.
Effects of Mental Practice on Manual Gripping Motor Function

The main objective is to evaluate and quantify the manual gripping force caused by mental practice


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60
* Healthy and with no pain subjects

Exclusion Criteria:

* Any cognitive impairment that hindered viewing of audiovisual material.
* Difficulty understanding or communicating.
* Presence of systemic pathology, Central Nervous System or rheumatic disease.
* Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
* Collaboration of pregnant women.
* Underage subjects
* Subjects with pain at the time of the study.
12 / 48 Week Pivotal PFT vs PBO in COPD I

This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).

The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.


Eligibility Criteria:
Inclusion criteria:

* All patients must have a diagnosis of chronic obstructive pulmonary disease
* Male or female patients, 40 years of age or older Patients must be current or ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1 \<80% predicted and post-bronchodilator FEV1/FVC \<70%

Exclusion criteria:

* Patients with a significant disease other than COPD
* Patients with a history of asthma
* Patients with any of the following conditions:

a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the past year. known active tuberculosis a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a history of cystic fibrosis
Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis: An Assessor-blinded, Randomized Controlled Trial

The aim of this randomized controlled trial is to compare outcome after construction of an ileal (J-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery.

The primary aim of this randomized controlled trial is to compare functional outcome in terms of bowel function correlated with quality of life for patients who undergo primary ileal pouch-anal anastomosis surgery with an ileal (J-shaped) reservoir length of either 10 cm or 15 cm.

Secondary aims include health-related quality of life measures and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis or familial adenomatous polyposis (FAP) (implying a normal sphincter function as judged by history and clinical examination)
* Signed informed consent
* Able to perform both a small (10 cm) and medium-size (15 cm) pouch with adequate reach and no tension as determined subjectively by the surgeon intraoperatively
Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT

Project UPLIFT, a home-based treatment for depression in people with epilepsy, was designed to be delivered to groups by telephone or Web. The Project UPLIFT intervention materials were demonstrated to be effective in treating depression among people with epilepsy in Georgia. This project will assess whether the materials are also effective for preventing depression among people with epilepsy, and will extend the project beyond Georgia to Michigan, Texas, and Washington.

The study is a pilot test of Project UPLIFT for depression prevention during which the acceptability and estimates of effectiveness of the intervention, presented in the Web and telephone modes, are assessed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of epilepsy
* at least three months post initial diagnosis of epilepsy and either on medication or permission of the physician
* symptoms of depression, but absence of moderate-to-severe depression, (8 \< CES-D \< 27)
* 21 years of age and older
* English speaking
* had access to a telephone
* mentally stable, as determined by a score of \> 26 on the Telephone Mini-Mental Status Exam (T-MMSE)
* willing to participate
* willing to complete assessments three times

Exclusion Criteria:

* no diagnosis of epilepsy
* less than 3 months since diagnosis of epilepsy
* no depressive symptom (CES-D \<8)
* severe depression (CES-D \> 27)
* suicidal ideation
* previous participation in Project UPLIFT
Observational Study Describing Conditions for Administering Slow-acting Insulin Analogue With Oral Antidiabetic Agents in Type 2 Diabetes on Blood Glucose Control

This study is conducted in Europe. The aim of this observational study is to describe the conditions for the concomitant administration of a slow-acting insulin analogue with oral antidiabetics (OADs) in order to improve blood glucose control in type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1c level greater than 7% despite treatment with two (or three) oral antidiabetic drugs (OADs) at an optimal dose level
* Patient agreeing to take part in the study and capable of completing a self-questionnaire.

Exclusion Criteria:

* Hypersensitivity to insulin or to one of the excipients
* Treatment with insulin for at least 6 months
* Participant in a clinical trial for diabetes on entry into the observational study
The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control Study

This study is an Investigator initiated, randomized, multicenter, double-blind, placebo-control study. The aim of this study is to evaluate the safety and efficiency of Sirolimus for primaty antiphospholipid syndrome patients at week 24 and week 48.


Eligibility Criteria:
Inclusion Criteria:

1. Understand and sign the informed consent form
2. Male or Female
3. aged 18-70 at the time of screening visit
4. Met 2006 Sapporo classification criteria of APS or 2023 ACR/EULAR classification criteria of APS
5. With the stable combination therapy

Exclusion Criteria:

1. history of serious adverse events or contraindication to Sirolimus
2. Catastrophic APS within 90 days
3. Acute thrombosis within 30 days
4. ≥4/11 American College of Rheumatology Classification Criteria for SLE or other systemic autoimmune diseases
5. Historically positive HIV test or test positive at screening for HIV
6. currently on any suppressive therapy for a chronic infection (such as tuberculosis, hepatitis B infection, hepatitis C infection, CMV, EBV, Syphilis, etc)
7. Surgery treatment within one month
8. History of malignant neoplasm within the last 5 years
9. White blood cell counts\<3×10\*9/L
10. Abnormal Liver function tests: ALT or AST ≥ 1.5 times the upper limit of the normal value, and total bilirubin and blood lipids ≥ 2 times the upper limit of the normal value
11. Pregnant or pregnancy preparation or breastfeed
12. Any circumstances that may cause the subjects to be unable to complete the study or pose significant risks to the subjects
Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma

This study is perform to study the effect of psychological and psychosocial factors associated with resilience to the self-stigmatization of people living with HIV

Epidemiological and sociological survey carried out with patients and their caregivers in the CHUs and CHGs of France via the COREVIH from 01/17/2022 to 02/17/2022.

Primary endpoint: Self-stigmatization as experienced by PLWHA will be explored through a patient questionnaire Secondary endpoints:The main explanatory variables will be studied by means of a custom questionnaire intended for the patient and covering psychological flexibility, social provisions, avoidance and fusion mechanisms, quality of life, anxiety and depression.

The socio-demographic explanatory variables will be collected by questionnaire, covering the following areas: sex, age, geographical origin, insecurity, drug use, sexuality, family context, employment, leisure, care environment.

A questionnaire intended for caregivers will study the self-stigmatization perception of the people they care for and the means implemented to fight against self-stigmatization.

Anonymous data will be reported in Redcap. The population will be described by numbers and percentages for categorical variables and by the mean ± standard deviation or the median \[interquartile range\] for the quantitative variables, with regard to their statistical distribution. Normality will be studied by the Shapiro-Wilk test and / or by histogram. As far as possible, graphical representations will be associated with the analyzes.

Eligibility Criteria:
Inclusion Criteria:

* For patients: adult patient, male or female, infected with HIV medically monitored in a hospital department involved in the investigation.
* Affiliation to a Social Security scheme For caregivers:Caregiver caring for people living with HIV as part of a hospital service involved in the survey (doctor, IDE, psychologist, other ...).

Exclusion Criteria:

* Minor patient
* Refusal of participation
* Persons under guardianship, guardianship or legal protection
Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

The purpose of this study is to see if giving growth hormone and Lupron along with thyroid hormone will improve final height in patients with long term hypothyroidism. Lupron is a medicine which is used to delay puberty and to prevent early closure of growing bones which might increase growth potential. Growth hormone is used to restore growth rate. This study will include children with "short term" and "long term" hypothyroidism.

Hypothyroidism is often associated with growth failure. It takes several years for slow growth to be noticed. This growth retardation is typically severe and progressive.

Thyroid hormone is necessary for normal growth. Treatment with thyroxine (thyroid hormone) results in rapid catch-up growth, which mostly happens during the first 18 months. Growth is accompanied by increased bone age, which means early fusion (closure of the growing bones) of the bones and reduced growth potential. For example, a patient, who is 10 years old but has bone age of 12 years, has growth potential of a 12 year old and will stop growing 2 years earlier than a 10 year old patient. According to the literature, prolonged juvenile hypothyroidism (low thyroid condition) resulted in a permanent loss in height and only 70% catch-up growth was generally achieved with thyroxine replacement.

Eligibility Criteria:
Inclusion Criteria:

1. Patients should have clinical and biochemical evidence of hypothyroidism, T4 less than 5.0 ng /dl , fT4 less than 1.0 mcg/dl and TSH of more than 10. Patients with prolonged hypothyroidism should have growth failure and delayed bone age of at least 2 SD from the mean. Patients with short term hypothyroidism should have normal growth velocity and bone age.
2. Females 8 to 16 years old.
3. Males 9 to 17 years old.
4. Patients without any chronic medical conditions.
5. Availability of a parent or guardian to attend study visits with the patient and to be actively involved in the patient treatment plan.
6. Give written informed consent prior to any study specific screening procedure with the understanding that the patient has the right to withdraw from the study at any time without penalty.

Exclusion Criteria:

1. Taking medications that affect their growth. (eg. Systemic corticosteroids, anabolic steroids)
2. Experiencing other health problems/conditions that affect their growth rate such as growth hormone deficiency, Cushing Syndrome, rickets, and chronic diseases.
3. Patients with any condition that is a contraindication for GH therapy would include conditions such as an active tumor, impaired glucose tolerance, neurofibromatosis (worsening of neurofibromatosis), and hypertrophy of tonsils and adenoids with sleep apnea. Contraindications for patients for GNRHa therapy would include a severe systemic reaction to GNRHa which is rare, osteopenia, and osteoporosis, because delaying puberty will worsen the condition.
4. Moving to a location that the patient will not be able to be followed by a pediatric endocrinologist.
5. Patient is not willing to continue with the study. -
Safety and Feasibility of Immuno-OCT

To improve detection of premalignant lesions in the gastrointestinal tract (the rectum and the esophagus) there is a need for better endoscopic visualization and the ability for targeted biopsies. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labelling the VEGF-A-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye bevacizumab-800CW (IRDye800CW). In several phase I studies and phase II studies, either completed or currently running, in the UMCG, the use of VEGF-A-guided near-infrared (NIR) fluorescence molecular endoscopy (FME) in combination with high-definition white light endoscopy (HD-WLE) shows an improved detection rate of early premalignant lesions. In this study the safety and feasibility of a next generation imaging system will be tested. This system uses immune optical coherence tomography (immuno-OCT) and near infrared fluorescence (NIRF) with the targeted tracer (Bevacizumab-800CW) for improvement of the detection of dysplastic lesions in Barret's esophagus (BE) and colorectal polyp detection. The system provides more depth information and can eventually be used without the guidance of the regular endoscopy system.


Eligibility Criteria:
Inclusion Criteria:

* Indication for a therapeutic endoscopy procedure (EMR or ESD);
* Age ≥ 18;
* Written informed consent.

Exclusion Criteria:

* Patients younger than 18 years old;
* Submucosal and invasive esophageal adenocarcinoma (EAC) or colorectal carcinoma (CRC);
* Radiation therapy for esophageal or colorectal cancer;
* History of infusion reactions to Bevacizumab or other monoclonal antibodies;
* Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer;
* Non-adjustable hypertension;
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
* Pregnancy or breastfeeding; a negative pregnancy test must be available for women of childbearing potential.
A Cluster RCT on TID

The brief intervention comprised the main intervention (tobacco industry denormalisation \[TID\] video, TID worksheet and sugar-sweetened beverages \[SSB\] worksheet) and booster intervention (worksheets where key contents in the main intervention reappeared).

The worksheets in the main intervention were printed in colour and contained eight pictures and eight texts which described the pictures. Students needed to match the pictures and texts. The booster worksheets contained the previous eight coloured pictures for the TID and SSB worksheet groups or six coloured screenshots from the TID video. Students needed to complete the six true or false questions based on the pictures provided.

Assessments were conducted immediately (T1), two weeks (T2), one month (T3) and three months (T4) after the main intervention.


Eligibility Criteria:
Inclusion Criteria:

* Parents' consent to their children's participation;
* Parents and children could understand Chinese.

Exclusion Criteria:

-
The Effect of Mentholyptus Drops on the Palatability of PEG-Electrolyte Solution

The investigators aim is to study the efficacy of mentholyptus drops in improving the palatability of PEG-electrolyte solution used in bowel cleansing for colonoscopy. The study is a randomized controlled trial which will include patients undergoing elective colonoscopy at the American University of Beirut Medical Center. Patients will be randomized into one of two study arms using a computer generated randomization list. Patients assigned to the intervention arm will be asked to have candy (Halls®) during the whole 2 hours period while drinking the PEG solution unlike the control arm patients who will only receive the PEG solution. All patients will then be evaluated for the tolerability of the preparation while taking into account the palatability of the solution as main outcome and the remaining volume of the PEG solution and side effects as secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* elective colonoscopy
* consent to the study

Exclusion Criteria:

* pregnant or lactating women
* age less than 18 years
* significant gastroparesis
* gastric outlet obstruction
* ileus
* known or suspected bowel obstruction or perforation
* phenylketonuria
* glucose-6-phosphate dehydrogenase deficiency
* severe chronic renal failure (creatinine clearance \<30 mL/minute)
* severe congestive heart failure (NYHA class III or IV)
* dehydration
* severe acute inflammatory disease
* compromised swallowing reflex or mental status
* uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
* toxic colitis or megacolon
* previous colonoscopy within the last 5 years
* active Inflammatory bowel disease
* previous colectomy or partial colectomy
Mechanism Study of Metabolic Response and Health Benefit Induced by Exercise

This study is a single-arm, self-control, single-center study to investigate the mechanism under exercise inducing metabolic response and health benefit. 40 overweight/obese patients with prediabetes will be recruited in this study and instructed to participate in an 8-week exercise program. We aim to investigate 1) the changes of phenotypes such as body weight, body fat, laboratory values, appetite, resting energy expenditure, myokine-adipokine before and after exercise 2) the changes of serum metabolomics 3) search for potential biomarkers of exercise through multi-omics integrated analysis of metabolomics, metagenomics, phenomics, single-cell transcriptome, etc.


Eligibility Criteria:
Inclusion Criteria:

1. Han Chinese
2. 5.6 mmol/L≤fasting blood glucose\<7 mmol/L, and/or 7.8 mmol/L≤2h-postload glucose\<11.1mmol/L, and/or 5.7% ≤HbA1c\<6.5% without anti-hyperglycemic medicine treatment
3. Voluntary participation and provide informed consent

Exclusion Criteria:

1. Participated in any clinical study in relation to weight-loss in the past 1 year
2. Had a weight change of more than 10% present weight in the past 1 year
3. Had a drug usage not suitable for this study in the past 3 months, such as hormone drug, orlistat, metformin, GLP-1 receptor agonists, lipid-lowering agents, liver protection drug, etc
4. Presence of diseases influencing glucose and lipid metabolism ,such as hyperthyroidism, hypothyroidism, Cushing syndrome, etc
5. Poorly controlled blood pressure: systolic blood pressure≥180mmHg, and/or diastolic blood pressure≥100mmHg
6. Presence of serious heart, liver, kidney or systemic diseases
7. Presence of skeletal and muscular diseases which make it difficult to exercise
8. Received any kind of surgery in the past 1 year
9. COVID-19 positive or recovery from COVID-19 within 4 weeks
10. Presence of eating disorders or have a history of eating disorders
11. Presence of sleep disorders
12. Work in disrupted circadian rhythms
13. Pregnancy and breastfeeding women
Optimization With SonR Method in the ClinicAl pRactice

Evaluate the percentage of patients optimized at least once every month by the SonR automatic optimization method, until M6 follow-up, in Heart failure (HF) patients prevalently in sinus rhythm

Thanks to the SonR technology it is possible to adjust the optimal VV and AV delays over time, in a fully automatic, time saving and operator independent way. It is possible to optimize the VV and AV delays in office, during follow-up visits, but also enable the automatic optimization that weekly optimize the AV and VV delays.

For the reasons mentioned above, the sponsor expects that the SonR optimization method increases the number of patients optimized systematically at each follow-up The purpose of this study is to evaluate the percentage of patients optimized at least once every month by the SonR automatic optimization method, until M6 follow-up, in HF patients prevalently in sinus rhythm.

The primary objective will be evaluated as the percentage of patients successfully optimized every month until M6.

A patient is considered successfully optimized by the SonR during one month if at least one Atri-Ventricular (AV) or Ventricular-Ventricular (VV) optimization is completed by the SonR automatic optimization method during the month.

Patients eligible for the analysis are those with SonR automatic optimization function enabled and at least 50% of the time in sinus rhythm

Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for implantation or implanted for less than 6 weeks (primo-implant, replacement, upgrade) with a a Paradym RF SonR CRT-D and SonRtip Atrial Lead, according to current available guidelines (RF=radio frequency)
* Patient has signed and dated informed consent (according to the laws and regulations of the country in which the observation is performed)

Exclusion Criteria:

* Persistent atrial arrhythmias
* Already included in another interventional clinical study
* Not available for routine follow-up visits
* Inability to understand the purpose of the study
* Under guardianship
* Under18 years old
* Drug addiction or abuse
* Pregnancy