cyrilzakka/clinical-trials huggingface dataset:
Mindfulness for Irritable Bowel Syndrome

This study investigates the effectiveness of a 6 week mindfulness intervention in reducing symptoms of Irritable Bowel Syndrome (IBS). All Participants will receive treatment. Participants will be randomly allocated to an immediate treatment group and a waiting list control group.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Diagnosed with IBS by Gastroenterologist or General Practioner (GP), meeting Rome III criteria for IBS, symptom onset at least 6 months prior to inclusion, discomfort or pain at least 2-3 days per month
* Participants speaks English fluently or at a native level
* Participant has normal or corrected to normal vision

Exclusion Criteria:

* Participant has insufficient manual dexterity for the computerized tasks
* Severe Diagnostic and Statistical Manual (DSM) Axis I or II psychiatric disorder (diagnosis of dementia, amnesia, delirium, a dissociative disorder, a personality disorder, schizophrenia or any other psychotic disorder, a substance-related or induced disorder (such as alcoholism), attention deficit hyperactivity disorder (ADHD), attention deficit disorder (ADD), primary diagnosis of obsessive compulsive disorder (OCD), current suicidality, regular non-suicidal self-injury.
* Recent bereavement (within one year)
* GI diagnosis other than IBS (IBD, coeliac disease, another FGID)
* Pregnancy
* No access to the internet
* Prior participation in an 8-week mindfulness course (MBSR, MBCT) or any other structured mindfulness training. Prior participation in Vipassana meditation courses. Regular meditation practice (meditating more than once per month).
* Not able or unwilling to commit to amount of practice (sessions and home practice).
* Participant is currently enrolled in another IBS treatment study (psychological or pharmacological).
The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding

Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.


Eligibility Criteria:
Inclusion Criteria:

* Adults 19 years and older
* Hospitalized in the surgical/medical intensive care unit of the Seoul National University Hospital
* Enteral nutrition
* Patients who consented to this study
* Patients with risk factors for pancreatic exocrine dysfunction

  * Shock (Norepinephrine)
  * Sepsis (3 rd definition of sepsis)
  * Diabetes
  * Cardiac arrest
  * hyperlactatemia serum lactate \> 2 mmol/L)
  * Mechanical ventilation
  * Continuous renal replacement therapy

Exclusion Criteria:

* chronic pancreatitis
* unresectable pancreatic cancer
* History of pancreatectomy
* Underlying diseases in which the effect of Exocrine pancreatic enzyme administration is difficult to show

  * Inflammatory bowel disease
  * Short bowel syndrome
Analysis of Pain and Quality of Life in Patients With Charcot-Marie-Tooth Neuropathy (CMT)

The study aims to qualitatively and quantitively evaluate pain in patients suffering from CMT with 3 standardized questionnaires (SF-36, NPSI-G, PAIN DETECT) as well as its impact on the quality of life.

Hereditary neuropathies are a group of clinically and genetically heterogeneous diseases of the peripheral nervous system. Charcot-Marie-Tooth disease (CMT), also known as hereditary motor and sensory neuropathy (HMSN), is the most common form of hereditary neuropathy with a prevalence of approximately 1 in 2,500 and with approximately 30,000 affected persons in Germany. There is no therapy known so far. In addition to the characteristic symptoms of a distal to proximal progressive symmetric muscular atrophy, especially of the lower extremities, there is a weakening of the muscles of the lower legs and feet, with emphasis on the "small" foot muscles and the peroneal muscle group, which clinically manifests as a so-called "stepper gait". It is also known that many CMT patients additionally suffer from pain, but more detailed studies on pain quality and quantity and their impact on patients' quality of life have not yet been systematically performed. These parameters will be investigated in this study, supported by the company Grünenthal, in the form of a questionnaire survey with validated questionnaires on pain and quality of life for at least 200 CMT patients. A representative result could lead to further investigations of pain in CMT patients and ultimately to the development of an adequate pain therapy.

Recruitment of patients will occur mainly through a call of the Germany-wide CMT registry, which is part of the national research network CMT-NET (coordinator: Prof. Michael Sereda). Interested patients are invited to contact the study team at the UMG. The patients will be informed about the study and if further interested 4 questionnaires (1 regarding the personal history as well as 3 standardized questionnaires from literature regarding quality of life and pain (SF-36, NPSI-G, PAIN DETECT) will be sent to the patients together with obligatory study documents and a pre-franked return envelope. A personal visit at the UMG is not planned, so that the patients don´t have any expenses. The data are pseudonymized at the UMG and transferred to a database and finally statistically evaluated by Gruenenthal.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of CMT
* Genetic confirmation of CMT diagnosis
* Age between 18 and 65 years
* Signed consent form

Exclusion Criteria:

* Other relevant neurological or psychiatric diseases, acute or past
* Serious internal medical illness
* Drug and / or alcohol dependence
* Participation in another clinical trial within 4 weeks prior to enrollment
Prospective Metabolic Indicator Study

The aim of this study was to assess the impact of a physician-supervised non-surgical medical weight management program on prevalence of metabolic syndrome and to examine the relationship between program retention and levels of key indicators of metabolic syndrome among participants that self-enrolled to the program. A total of 479 overweight or obese participants aged 19 years or older were observed. The revised National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria were used to define metabolic syndrome.

Each individual self-enrolled to a physician-supervised non-surgical weight management program, hereafter referred to as the Program. They received a weight loss intervention as a part of routine medical care in the Program. At the end of their first consultation, each individual that met the inclusion criteria and failed to meet the exclusion criteria was asked if he or she would like to join the study. Each individual was informed that the study would not change the type or level of care that he or she would receive while enrolled to the program; however, researchers would be studying the effects of their care through additional screenings. Individuals who thereafter signed an informed consent form were monitored for changes in health outcomes without change to the Program.

This study was observational. Health outcomes were assessed in individuals that predefined their program status (i.e., enrolled or not enrolled). Each participant received routine medical care, and the investigators studied the effects of the intervention. No new intervention or intervention specific to participants only was assigned.

Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 18 years of age.
* The patient is overweight or obese (BMI≥25 kg/m2).

Exclusion Criteria:

- The patient was previously enrolled in the Medi-Weightloss program
Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.


Eligibility Criteria:
Main Inclusion Criteria:

* Participant and/or legal representative has/have voluntarily provided signed informed consent
* Participant is 12 to 65 years old at the time of screening
* Participant is male with severe hemophilia A (Factor VIII (FVIII) clotting activity \< 1%) as confirmed by central laboratory at screening after the appropriate washout period or a documented FVIII clotting activity \<1%
* Participant has been previously treated with plasma-derived FVIII concentrates or recombinant FVIII for ≥150 documented exposure days (EDs)
* Participant is currently receiving prophylaxis or on-demand therapy with FVIII
* Participant is willing and able to comply with the requirements of the protocol

Main Exclusion Criteria:

* Participant has detectable FVIII inhibitory antibodies (≥ 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening
* Participant has history of FVIII inhibitory antibodies (≥ 0.4 BU using the Nijmegen modification of the Bethesda assay or ≥ 0.6 BU using the Bethesda assay) at any time prior to screening
* Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease).
Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis

This study objective is to check the non-inferiority of the 2 formulations produced by EMS when compared with the same substances and pharmaceuticals forms of the product Condroflex (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and functional capacity that will be periodically measured by using the "Visual Analog Scale" of pain (VAS) and the questionnaire of Lequesne.


Eligibility Criteria:
Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the Informed Consent;
* Patients of both sexes;
* Age above 30 years;
* Clinical and radiological diagnosis of osteoarthritis;
* Osteoarthritis in grades 1-2;
* Patients who are conducting medical treatment and that, for trial of Investigator, is eligible for the study.

Exclusion Criteria:

* Patients with a history of trauma clinically significant;
* Patients who underwent surgery on joints affected;
* Coexistence of diseases that might impede the successful conclusion of the trial (rheumatism and others);
* Pregnant patients and / or breastfeeding;
* Patients with phenylketonuria;
* Patients with clinical diagnosis of severe renal failure;
* Patients with clinical diagnosis of severe liver disease;
* Patients with clinical diagnosis of clotting disorders;
* Patients who are being treated with anti-aggregating and / or anticoagulants;
* Patients with sensitive components of the formula;
* Patients with emotional disorders that interfere with the capture of data;
* Patients who do not agree with the purposes of the study and did not sign the Informed Consent.
Decreasing Stress and Improving Self-control With "Stress in Control" (Sync) Training

This is a study of treatment approaches aimed to improve self-control and decrease stress and unhealthy/maladaptive behaviors such as drinking, overeating, and smoking.

High levels of stress may make it harder to maintain self-control, especially when trying to control our unhealthy behaviors. Training on improving self control and decreasing stress may help decrease unhealthy behaviors. The goal of this new training program will be to decrease a subject's unhealthy behavior by helping them better manage their stress and improve their self control over unhealthy habits.

This study proposes to pilot a mindfulness based affect-regulation treatment approach to improve self-control and physiological and biochemical indicators of stress, as well as decrease unhealthy/maladaptive behaviors such as drinking, overeating, and smoking. The broad aims of the treatment approach will be to teach participants to (1) observe and increase awareness of cognitive, affective, bodily sensations/expressions and action-urge components of emotional/compulsion experiences; and (2) develop alternate affective, behavioral and cognitive coping strategies in managing and regulating affect/urge experiences. It is hoped that the findings from this study will aid in the further development of treatment and prevention programs targeting stress reduction and coping to improve control over maladaptive behaviors and decrease physical and mental health symptoms.

Aims:

1. Develop a mindfulness based affect-regulation therapy manual, and training materials to train therapists on a treatment approach aimed at improving self-control over unhealthy addictive behaviors.
2. Develop and implement "Stress in Control" (SynC) training competence and adherence rating scales;
3. Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness and feasibility of SynC in comparison to a Primary Care Treatment Control Group and a Historical Control Group approach for 100 individuals interested in help in decreasing targeted unhealthy behaviors. Primary outcomes will be a reduction in unhealthy problem behaviors, and secondary outcomes will be decrease in measures of stress, and increases in emotion regulation and self control.
4. (secondary aim) Collect baseline data on measures of self control, mood, coping, personality, cognitive functioning, acute and chronic stress, and mental and physical health on a large sample of subjects seeking help in decreasing unhealthy behaviors.

Eligibility Criteria:
Inclusion Criteria:

1. Between ages 18-60 years;
2. Able to read and write;
3. Interested in treatment aimed at gaining greater control over an unhealthy, maladaptive behavior

Exclusion Criteria:

1. Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
2. Pregnant women will be excluded.
3. Inability to give informed consent
4. Traumatic brain injury or loss of consciousness
5. Medical problems requiring immediate attention
Characterizing the Genotype and Phenotype in Adults With Bardet-Biedl Syndrome

Bardet-Biedl syndrome (BBS; OMIN #209900) is a rare genetic disorder characterized by six core features: rod-cone dystrophy (retinitis pigmentosa), polydactyly, obesity, genital anomalies, renal anomalies, and learning difficulties. This study aims to contribute to genetic and medical knowledge of BBS, and to provide information on quality of life in adults with BBS and their close relatives. Participants will undergo medical assessments (ocular, oral, and physical examinations) and self-reporting of quality of life, diet, cognitive and emotional symptoms. There are some known genotype-phenotype associations in BBS and participants will be offered genetic testing. It is important to map both genotype and associated phenotype in order to provide optimal treatment and follow-up. Individuals with BBS, age 16 years or older, will be invited to participate. The investigators expect to enroll at least 25 male and female adults with BBS and 15 of their parents to participate in qualitative interviews. These interviews will investigate parents' experiences having a child with BBS, satisfaction with health care services, experience with social and family life, and psychological health.

Improved care for adults with BBS living in Norway necessitates increased knowledge of pertinent health-related, emotional, and educational, employment and psychosocial issues. Adults with BBS living in Norway may face new challenges and have unmet healthcare needs. Therefore, the investigators intend to evaluate the adult with BBS as a person with special needs (e.g. need for support systems, lack of social opportunities, and mental health problems) and long-term challenges.This project will describe the visual, medical, physical, nutritional, and psychological difficulties experienced by people with BBS. The planned multi-disciplinary clinical evaluation in this study can help address the existing knowledge gaps. Relatives who help their loved ones with various activities of daily living may experience reduced quality of life and altered social roles. Therefore, the investigators also want to study the quality of life and psychological status of close relatives. This project might contribute information for new clinical protocols and suggest areas for further research in genetics, healthcare needs and quality of life for people living with BBS.

Eligibility Criteria:
Inclusion Criteria:

Individuals diagnosed with BBS (see below), age 16 years or older. BBS is characterized by six core features : rod-cone dystrophy (retinitis pigmentosa), polydactyly, obesity, genital anomalies, renal anomalies, and learning difficulties.

Additional features include speech delay, developmental delay, diabetes mellitus, dental anomalies, congenital heart disease, brachydactyly (shortening of fingers/toes), ataxia, and anosmia/hyposmia (deficienct sense of smell). A minimum of four of the core features, or three core features and two additional features are required for the clinical diagnosis of BBS.

Exclusion Criteria:

Individuals age \< 16 years, current severe illness or known diagnosis of autism.
The Impact of Sensory Integration on Attention in Autism

The study aims to examine how the mode of presentation of visual and auditory stimuli-separate or simultaneous-affects accuracy and reaction time in visual-auditory association in participants with Autism Spectrum Condition (ASC) compared to neurotypical individuals. The study aims to evaluate whether sensory overlap (simultaneous stimuli) increases cognitive load and decreases performance, while stimulus separation (separate presentation of visual and auditory stimuli) may facilitate processing and improve performance, especially in participants with ASC. Participants will be divided into two main groups: the first consisting of individuals with ASD and the second of neurotypical individuals. Each group will be exposed to two modes of stimulus presentation: simultaneous mode, in which visual and auditory stimuli are presented at the same time, and separate mode, in which visual and auditory stimuli are presented separately with a time interval between each. Participants will be required to complete visual-auditory association tasks. In addition to assessment of reaction time and accuracy, psychophysiological parameters will be recorded to measure cognitive load and physiological reaction to stimuli. The main hypotheses are that the simultaneous presentation of visual and auditory stimuli will increase cognitive load and reduce accuracy and reaction time in individuals with ASC, while the separate mode will improve performance, especially in the group with ASC. This study could provide important insights into how stimulus presentation mode affects learning and performance in participants with ASC, suggesting that stimulus separation could be a useful strategy for optimizing sensory processing and improving learning in educational and therapeutic settings.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism
* QI ≥ 80

Exclusion Criteria:

* significant hearing or visual impairments
* presence of other medical disorders
* history of psychiatric diagnosis
Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

Study to Evaluate the Safety and Pharmacokinetics of CKD-349

An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
5. Those who agree to contraception until 7 days after clinical trial.
6. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who have clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and urogenital system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
3. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products or take drugs that may interfere with this clinical trials within 10 day before the first administration
4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
5. Those who donated whole blood within 8 weeks or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks.
6. Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
7. Those who overreacts to the ingredient of this drug and is administering an angiotensin conversion enzyme (ACE) inhibitor or has not passed 36 hours since discontinuation of administration and has a history of vascular edema when administering an angiotensin conversion enzyme (ACE) inhibitor or an angiotensin receptor antagonist (ARB).
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.