cyrilzakka/clinical-trials huggingface dataset:
Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes

Diabetes is a growing global health care challenge. Diabetes patients may also suffer from cardiovascular autonomic neuropathy (CAN) which may affect cerebral perfusion. The main purpose of this project is to investigate the association between CAN and disturbances in the neurovascular coupling in type 2 diabetes patients. Moreover, the purpose is also to investigate coherence between CAN and the enteric nervous system. Finally, this project aims at delineating microstructural changes in the brain tissues as a consequence of CAN.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of type 2 diabetes (Patients)
* Age between 50-70 years (All)
* Presence of CAN as diagnosed by cardiovascular reflex tests with two or three pathological results (Patients with CAN only)
* Exclusion of CAN as diagnosed by cardiovascular reflex tests with no pathological results (Patients without CAN and HC only)

Exclusion Criteria:

* Participants receiving treatment with direct effects on noradrenergic or cholinergic signaling (for example beta-blockers, tricyclic antidepressants, SSRI's) (All)
* Acute infections (All)
* Thyroid disease (All)
* Substance or alcohol abuse (All)
* Atrial fibrillation or flutter (All)
* Respiratory failure (All)
* Participants in active laser treatment for retinopathy, will be excluded from the Valsalva test (Patients)
* Non-diabetic causes of neuropathy including a medical history of vitamin B12 deficiency, folic acid deficiency, rheumatoid arthritics, amyloidosis, HIV, syphilis, Borreliosis, drug induced neuropathy and neuropathy caused by toxins (All)
* Claustrophobia (All)
* Implanted pacemakers or remaining pacemaker electrodes (All)
* Previous heart or brain surgery with use of metal clips (All)
* Any form of non-MR-compatible implants
* Non-compliance with the study protocol as judged by the investigators (All)
* Concurrent participation in an intervention study (Patients)
* Participants who by judgments of the investigator, is incapable of participating (All)
Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation

The purpose of this study is to evaluate the feasibility and preliminary effectiveness of delivering a personalized, just-in-time adaptive intervention driven by machine learning prediction of smoking lapse risk in real time.


Eligibility Criteria:
Inclusion Criteria:

* a score greater than or equal to 4 on the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM-SF),12
* willingness to quit smoking 14 days after the baseline visit
* no contraindications to using Nicotine replacement therapy (NRT).
* If participants would like to use their own phone to complete the EMAs, they must additionally have an Android smartphone (Android 5.2 or higher), and be willing to install the InsightTM mHealth app on their phone.

Exclusion Criteria:

* currently smoking less than 5 cigarettes per day
To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis

This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Minimum 19 years old
* Kellgren stage I \~ III by ACR criteria
* Stable osteoarthritis during 3 months
* Be able to perform WOMAC and KKS
* Written consent form voluntarily

Exclusion Criteria:

* Disease of orthopaedic surgical that could affect to evaluate the efficacy
* Medication of continuous corticosteroid by oral or articular cavity within 12 weeks
* Medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics within four weeks
* Medical history of hypersensitivity reaction against Herbal drug
* Genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose malabsorption, etc.
* Occurrence of OA caused by the injury
* Diagnosed with psychical disorder, and taking medication
* Diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure, clinically significant ischemic heart disease, peripheral arterial disease, or cerebrovascular diseases
* Diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it
* Abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.)
* Positive in fecal occult blood test
* Gastrointestinal tract surgery except appendectomy
* Serum creatinine, ALT, AST, total bilirubin over UNL x 1.5 at screening test
* Participation in another clinical trials within 4 weeks
* Not consent about using effectual contraception method during trial
* Pregnant or lactating woman
* Medical history of malignant tumor within 5 years
* Investigator's judgment
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).


Eligibility Criteria:
Inclusion Criteria:

* term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
* clinical diagnosis of GERD
* weight greater than 2.5 kg and less than or equal to 15 kg

Exclusion Criteria:

* known history of upper GI anatomic disorders
* history of acute life-threatening medical conditions
* clinically significant medical conditions or laboratory abnormalities
The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment

Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.

Primary Objective:

Use both listed and relatively safe drug, Silymarin, to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.

Patient Selection and Enrollment:

Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.

Plan of the Study:

Study Design This is an open-label, randomized, comparative, double arm, single center study to assess efficacy of Silymarin as adjuvant therapy on metastatic colorectal cancer patients undergoing FOLFIRI chemotherapy in Taiwan.

Subject Number Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.

Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB) Duration of study: From the date of the IRB was approved till the 70th patient was collected.

Duration of Enrollment: From the date of the IRB was approved till the 70th patient was collected.

Duration of treatment: From the 1st patient starting chemotherapy till the 70th patient finishing the 6th cycle chemotherapy.

Duration of follow-up: From the 1st patient starting chemotherapy till 3 months after the 70th patient finishing the 6th cycle chemotherapy

Eligibility Criteria:
Inclusion Criteria:

1. The patient who is between 20 to 80 years old
2. The patient who is diagnosed metastatic colorectal cancer and received chemotherapy with FOLFIRI regimen
3. The female patient should not be pregnant or breast-feeding
4. The patient who has no severe co-morbidity, such as cardiovascular, cerebrovascular, malignant hypertension, renal and hepatobiliary disease.
5. The patient who has no associated drug allergy to this trial.
6. The patient who is in compliance with prescribed medication.
7. The patient who is willing to sign the permit of the clinical trial.

Exclusion Criteria:

1. The patients who do not meet the main inclusion criteria or are not willing to sign the permit.
2. The patient who has viral hepatitis or carrier with impaired liver function.
NHANES Urinary Sodium Calibration Study

This proposed calibration study is designed to evaluate the correlation of urinary sodium excretion between NHANES timed urine and 24-hour urine collections.

The study will be conducted with 400 volunteer participants aged 18-39 years old. Participants will be asked to collect urine samples over a 24-hour period. One-third of the participants (n=133) will be asked to collect a second 24-hour urine 4-11 days later. A 24-hour dietary recall interview will be collected after the completion of each 24-hour urine collection. Results from this study will be used to assess how well the sodium excretion estimated from NHANES timed urine correlates with data from 24-hour urine collection. It will provide valuable information on the potential of NHANES timed urine collections to be used to characterize trends in U.S. population sodium intake.

Eligibility Criteria:
Inclusion Criteria:

English speaking

* Aged 18-39 years old
* 50% Black; 50% all other
* 50% male; 50% female
* At least 50 (25 male; 25 female) of the 400 participants likely to have high sodium diet indicated by selected dietary behaviors
* At least 50 (25 male; 25 female) of the 400 participants likely to have low sodium diet indicated by selected dietary behaviors

Exclusion Criteria:

* Pregnant or trying to get pregnant.
* Taking loop diuretics
* Chronic kidney disease
* New hypertension treatment or change in hypertension treatment in the last 2 weeks
Effects of SARAH Protocol in Women With Rheumatoid Arthritis

The aim of this randomized controlled trial is to analyze the effect of the SARAH protocol, which is a set of exercises with components of muscle strengthening, range of motion gain and home exercises, combined with an educational intervention, on hand function in women with rheumatoid arthritis (RA).

The volunteers will be randomized between groups: control group (n=30), which will receive usual guidelines and the SARAH group (n=30), which will perform the SARAH protocol exercises (brazilian portuguese version) along with the usual guidelines. To participate in the research, patients must be diagnosed with RA using disease-modifying antirheumatic medication for at least 3 months, and age equal to or older to 18 years. Participants with incomplete elementary school and score \<24 on the Mini-Mental State Examination Questionnaire (MMSE) will be excluded from the study. The participants will be evaluated before and after the intervention regarding the variables: hand function (Michigan Hand Outcomes Questionnaire), pain (Brief Pain Inventory), handgrip strength (Jamar® manual dynamometer), quality of life (Euro Quality of Life Instrument-5D), functional capacity (Health Assessment Questionnaire), RA disease activity (DAS28). The SARAH group will receive an exercise book containing 7 mobility exercises and 4 strength exercises that are performed using elastic materials that provide progressive degrees of resistance to movement. Patients will be guided in person by a trained professional, so that they are carried out without their presence, in the home environment, daily and monitored at periodically scheduled meetings. A total of 4 face-to-face meetings will be held during the 3-month follow-up. The SARAH group and the control group will receive information related to joint protection, use of splints, assistive devices and other general advice, as needed, will receive some booklets to reinforce the guidelines. The program will last 12 weeks, with 4 face-to-face meetings lasting 40 minutes and monitored in periodically scheduled meetings.

Eligibility Criteria:
Inclusion Criteria:

* patients must be diagnosed with RA
* using disease-modifying antirheumatic medication for at least 3 months
* over 18 years old

Exclusion Criteria:

* incomplete elementary school and score \<24 on the Mini-Mental State Examination Questionnaire (MMSE)
* diagnosis of another associated autoimmune disease
* having undergone previous surgical procedures on the hands
* having suffered a fracture in the joints of the upper limbs in the last six months
* being a patient on the waiting list for orthopedic surgery of the upper limb
* being pregnant.
Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study

Objective: to evaluate if a fully-automated diagnostic interview for insomnia disorder is suitable for clinical and research purposes (adequate sensitivity and specificity) and is acceptable to patients.

Study main outcomes:

1. Concurrent validity (sensitivity and specificity) compared to a gold standard. Gold standard: clinical diagnosis of a clinician using a validated structured clinical interview for the DSM 5 criteria of insomnia disorder
2. Acceptability of the fully-automated interview.

Participants:

Volunteers to undergo the clinical and the automated interview will be recruited through non-probability convenience sampling from patients attending the sleep clinic at Bordeaux University Hospital between May 2023 and July 2023.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Being able to communicate and read in French
* Previous use a mobile phone

Exclusion Criteria:

* N/A
National Polish Registry of Minimally Invasive Liver Surgery

After the two consensus meetings on laparoscopic liver resection in Louisville (2008) and in Morioka (2014) minimally invasive approach for liver resection was finally widely established in liver surgery practice. Successively more countries follow laparoscopic liver pioneers and apply laparoscopic liver surgery for everyday practice.

Primary aim of the study is to assess the evolution and diffusion of minimally invasive liver surgery in Poland. Secondly, it will allow to assess the actual short- and long-term results of laparoscopic liver resections and compare it to the international benchmark values.

The National Polish Registry of Minimally Invasive Liver Surgery will include data about all cases of laparoscopic liver resections performed in Poland since the first case in 2010. All surgical departments, where laparoscopic liverresection is regularly performed, will be invited. Data of demography, previous medical history, preoperative assessment, intraoperative and postoperative period, histopathological findings and long-term follow-up will be included in the registry.

This study will be the first national report about diffusion of minimally invasive surgery in Poland.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* underwent laparoscopic liver resection
Study on Predictiors and Mechanism of Conversion to Psychosis in Individuals at Ultra-high Risk Group

Considering the complex pathological mechanism and the poor treatment outcomes of schizophrenia, early detection and intervention gradually become the key work for the foundational and clinical research in schizophrenia. Ultra-high risk for psychosis (UHP) is defined as individuals at the prodromal stage of schizophrenia. Early intervention in individual at UHP can effectively delay or even prevent the development of the illness. Long-term longitudinal studies suggested that there are clinical outcomes in people at UHP. Nearly 1/3 of individuals at UHP may be naturally relieved without any intervention, about 1/3 of individuals at UHP will remain at the prodromal stage of schizophrenia, and only 1/3 individuals at UHP will eventually develop schizophrenia. In this regard, it will cause adverse effects on false positive individuals if they accept clinical intervention. Unfortunately, it is difficult to accurately predict which individuals at UHP will make a transition to frank illness. To solve this issue, we explore the association between baseline brain structural and functional networks, methylation modifications, gene expression, neurocognitive function and the clinical outcomes of UHP individuals, and to identify the potential biological and clinical predictors for the long-term outcomes in the individuals at UHP. In addition, we also detect the changes of brain structure and function, methylation status and gene expression in individuals at UHP during follow-up, and further to investigate the etiology and pathogenesis of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* 1. age of 13-30 years;
* 2. meet the diagnostic criteria of COPS prodromal syndrome by SIPS clinical interviews;
* 3. have not received any psychiatric medication;
* 4. be in good health, without major mental illness or physical illness;
* 5. normal intelligence, can be operated on a clinical scale;
* 6. volunteer to participate in the study and sign the written consent form.

Exclusion Criteria:

* 1. exclusion of current or previous psychiatric disorders by SCID interview;
* 2. meet the diagnostic criteria for substance abuse and substance dependence in DSM-IV;
* 3. contraindications for MRI;
* 4. pregnant or lactating women.
Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh

The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.


Eligibility Criteria:
Inclusion Criteria:

* 6 to 18 months; either sex, having no acute illness, and be on at least one semi-solid or solid food in a day.

Exclusion Criteria:

* loss of appetite,
* oral lesion,
* congenital anomaly/acquired disorder affecting growth,
* severe acute malnutrition (SAM) defined by:

  * MUAC \< 115 mm or
  * WL \< -3 Z score or
  * bipedal edema,
  * persistent diarrhea,
  * tuberculosis,
  * any other chronic illness.
The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy

There is an ongoing debate whether antihypertensive treatment with beta-blockers and/or angiotensin converting Enzyme (ACE)-inhibitors comprises a risk factor for more severe and more frequent side-effects during venom immunotherapy (VIT). In the literature, data are controversial and originate from case reports or statistically underpowered studies; the number of included patients was usually high but the proportion of patients on antihypertensive treatment was low ranging from 2-11%.

The study was conducted as a prospective, observational, European multicenter study. 1425 patients, aged from 35 to 85 years, with a history of an anaphylactic reaction due to bee or wasp stings, were included. The medical history was recorded as well as laboratory parameters and data of the VIT-updosing phase. One year after reaching the maintenance dose, possible side-effects during VIT as well as the outcome of field stings or sting challenges were documented.


Eligibility Criteria:
Inclusion Criteria:

* History of systemic sting reaction (≥ grade I according the classification by Ring and Messmer)
* age 35 to 85 years

Exclusion Criteria:

* absolute contraindications for VIT
* pretreatment with Omalizumab
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting

An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting. 20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation anxiety, specific phobia and their parents will be recruited from the CAMHS-center in Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and parent-rated anxiety and functioning.


Eligibility Criteria:
Inclusion Criteria:

* 8-12 years of age
* Fulfilling diagnostic criteria for Generalized Anxiety Disorder (GAD), Separation anxiety, Specific phobia
* Ability to read and write Swedish
* Daily access to the internet
* A parent that is able to co-participate in the treatment
* Participants on psychotropic medication must have been on a stable dose for the last 3 months prior to baseline assessment

Exclusion Criteria:

* Diagnosed autism spectrum disorder or Attention-deficit/hyperactivity disorder (ADHD), or principal primary disorder other than GAD, Separation anxiety, Specific phobia
* Acute/severe psychiatric problems such as suicidal risk or severe depression
* Ongoing psychological treatment for anxiety disorders
* Ongoing child custody dispute or abuse in the family
Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry. Scales asking sensational integration and severity of plagiocephaly will also be used. Time of daily usage will be follow with daily asking the caregivers how long the baby wear the helmet in a day. Participants will follow for three months.

Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry. Scales asking sensational integration and severity of plagiocephaly will also be used. Time of daily usage will be follow with daily asking the caregivers how long the baby wear the helmet in a day. Participants will follow for three months. After the follow period completed, participants will be allocated two groups; avarage using 15-18 hours a day and avarage using 19-23 hours a day. Results will be compared for the two groups and correlation between the time of usage and cranial symmetry will be compare.

Eligibility Criteria:
Inclusion Criteria:

have deformational plagiocephaly consent from caregivers age between 1 day to 7 months

Exclusion Criteria:

have another systemic, neurologic or orthopedic problem