cyrilzakka/clinical-trials huggingface dataset:
SHame PrOpensity in BOrderline Personality Disorder

Borderline Personality Disorder (BPD) is a common psychiatric disorder occurring in 2 to 6% of the population. 70% of patients with BPD do at least one Suicide Attempt (SA) in their lives. It makes BPD the most related to SA condition.

Negative interpersonal events are among the main stressor inducing a SA. Patients with BPD are characterized by emotional dysregulation, impulsivity (repeated parasuicidal and suicidal behaviors), and instability in interpersonal relationships. The feeling of shame related to this psychiatric disorder could be one of the causes of the high SA rate. In this study, patients with BPD will be follow-up during 5 years.

The main objective is to study the propensity to feel shame as a predictor of SA.

This include:

* Study of shame propensity as a predictive factor of suicidal behavior - Identify homogeneous subgroups of patients with BPD based on SA, and overall functioning.
* Identify biological markers predicting SA
* Identify predictive and protective treatments (pharmacological and psychotherapeutic) for SA

This is a 5 years follow-up prospective study recruiting 688 patients.

Schedule of the study :

Inclusion period : 3 years Duration of follow-up of each patient : 5 years Estimated duration of the study : 8.5 years

As part of the research, patients will be summoned annually for 5 years.

The first visit (at baseline) is included in the usual care

The follow-up visits are specifics to the research

During the visits patients will complete self questionary and clinical interview.

The organization of visits is as follows:

* an inclusion visit lasting around 2 hours (clinical evaluation and then self-questionnaires)
* a visit to 1 year, 2 years, 3 years, 4 years and 5 years (+/- 1 month) lasting approximately 1 hour 30 (clinical evaluation and passing of self-questionnaires)

Genetic samples will be taken during the initial visit as well as during the visit to 5 years.

They consist of:

* A genetic collection consisting of a DNA library (3 Ethylene Diamine Triacetic Acid (EDTA) tubes of 6ml - 18 ml).
* An off-genetics collection consisting of serum and plasma samples, (1 6 ml EDTA tube, 1 4 ml heparinized tube, 2 dry tubes of 5 ml each and 2 citrated tubes of 2.7 ml each - 25 , 4 ml).

Eligibility Criteria:
Inclusion criteria:

* To be over 18
* Clinical diagnosis of BPD using the SCID II (Structured Clinical Interview for DSM-IV-Text Reviewed Axis II Personality Disorders)
* Having signed the informed consent
* Able to understand the nature, the purpose and the methodology of the study
* Able to understand and perform the clinical evaluations

Exclusion criteria:

* Deprived of liberty (by judicial or administrative decision)
* Protected by law (guardianship)
* Exclusion period in relation to another protocol
* Not affiliated to a social security scheme
University Of Pennsylvania Weight Loss Study

This is a 4-arm, randomized controlled trial to evaluate the effectiveness of financial incentives to motivate and sustain long-term weight loss. The study will recruit eligible employees at a large health management company to participate in a 6-month weight loss program and have weight measurements for an additional 3-month follow-up period. The primary outcome measure in this randomized controlled trial will be pounds of weight lost. The experimental groups will include variations of deposit contracts (participants put their own money at risk, and lose that money if they fail to achieve their weight loss goal) and fixed payments. The use of deposit contracts is a powerful mechanism for inducing behavior change that is based on loss aversion, a psychological concept first described by Nobel Prize winner Daniel Kahneman and Amos Tversky in 1979. A deposit contract takes advantage of the fact that people typically feel the pain of a loss more than the pleasure of a gain, increasing ones motivation to reach a goal.

The study hypotheses are 1) mean weight loss will be greater in all intervention groups compared to the control group by the end of 24 weeks; and 2) individuals in the intervention groups will have a lower mean weight at the end of the 3-month follow-up period than individuals in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 70 (inclusive)
* BMI between 30 and 50 (inclusive)

Exclusion Criteria:

* Inability to consent
* No known Illiteracy and/or inability to speak, read, and write English
* Participation in another weight loss program
* Participation in another research study
* Current treatment for drug or alcohol use
* Consumption of 5 alcoholic drinks per day
* Myocardial infarction or stroke within the past 6 months
* Uncontrolled hypertension (defined as BP170 mm Hg systolic or BP110 mm Hg diastolic)
* Current addiction to prescription medicines or street drugs
* Serious psychiatric diagnoses (severe depression, schizophrenia)
* Pregnancy
* Diabetic and using any medicine besides metformin to control blood sugars
* Metastatic cancer
* Unstable medical conditions that would likely prevent the subject from completing the study
* Previous diagnosis of an eating disorder
* History of unsafe weight loss behaviors such as binging or the use of laxatives
Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment

This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A treatment in poststroke patients with spasticity of the upper-limb flexors


Eligibility Criteria:
Inclusion Criteria:

* Medically stable poststroke with focal unilateral upper-limb spasticity

Exclusion Criteria:

* Stroke within 6 months of the study enrollment visit
* Previous or current botulinum toxin therapy of any type in the study limb
EASY: Extended Access to Sollpura Over Years

Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice.

The purpose of the present study is to evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis)

Exclusion Criteria:

* Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study.
* Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.
Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms

In this project the investigators study the safety and efficacy of the pipeline embolization device with vantage technology in treatment of unruptured brain aneurysms


Eligibility Criteria:
Inclusion Criteria:

* All patients treated with Pipeline Embolization Device with Vantage Technology (PEDV)
* MRA and/or DSA (or tomographic angiography) available for follow up

Exclusion Criteria:

* Insufficient background data available e.g., to determine size of aneurysm and pipeline device
* PEDV used for causes other than aneurysms, e.g., fistulas and dissection.
Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old Children ( DTaP/DT )

This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.

A phase 4 trial was conducted in Zhejiang Province aimed to evaluate the immunogenicity and safety of DTaP or DT in children aged 6 years. DTaP and DT are produced by Chengdu Institute of Biological Products Co., Ltd. Participants will be recruited and randomly divided into two groups to receive DTaP or DT in 1:1 ratio. Two blood samples were taken on Day 0 (pre-vaccination) and Day 28\~42 (after-vaccination) for test antibody against pertussis, diphtheria and tetanus. Adverse events and serious adverse events were actively collected by staff within 28 days of vaccination.

Eligibility Criteria:
Inclusion Criteria:

* 1. Participants aged ≥ 6 on the day of enrollment; 2. Informed consent should be signed and dated by the participants; 3. The participant's legal guardian is able to attend all planned follow-up visits and comply with all study procedures; 4. The participants have received 4 doses of acellular TDap vaccine and have not received any immunization agents related to diphtheria, tetanus, and pertussis in the past 3 years; 5. The participant has no diease history of pertussis, diphtheria or tetanus; 6. ≥ 14 days interval between the last vaccination; 7. Body temperature was ≤37.3℃.

Exclusion Criteria:

* 1、Being allergic to any component of vaccines ； 2、A history of severe allergic reactions to any vaccine (for example acute allergic reaction, angioneurotic edema, dyspnea, etc）； 3、Having a history or family history of convulsions, encephalopathy, psychosis, uncontrolled epilepsy and other progressive neurological diseases; 4、Participants are suffering from immunodeficiency, receiving immunosuppressant therapy (oral steroid hormones) during treatment for malignancy, or having low immunity due to HIV, or having congenital immune disorders in close family members; 5、Injection of non-specific immunoglobulin within 1 month before enrollment; 6、Participants are suffering from acute febrile diseases and infectious diseases; 7、A history of clearly diagnosed thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection; 8、Participants with severe chronic diseases or acute episodes of chronic diseases; 9、Participants with infectious, suppurative and allergic skin diseases; 10、Other Participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence

Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse potential. The purpose of this study is to examine the effectiveness of buprenorphine/naloxone that is given at less than daily intervals, in order to prevent withdrawal symptoms associated with stopping opioid abuse.

Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are attempting to stop opioid abuse; however, research suggests that individuals may be more inclined to take medication if it is given in less than daily intervals. The purpose of this study is to examine the opioid blockade effects of buprenorphine/naloxone that is administered in less than daily doses to opioid dependent individuals.

This study will last 11 weeks. Participants will stay in a residential research unit for the duration of the study. Participants will be randomly assigned to receive different doses of daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose, participants will undergo challenge sessions on each weekday for 1 week (Monday through Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone. During the challenge session week, buprenorphine/naloxone will be given only on Monday; a placebo will be given the rest of the week. Challenge sessions will examine the blockade effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose of buprenorphine/naloxone.

Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for opioid dependence
* Qualifies for opioid substitution treatment (e.g., methadone)

Exclusion Criteria:

* Significant psychiatric or physical disorder
Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients

This study will compare Drager Smart Care (SC), a commercially available automated ventilator controlled weaning mode to the current daily spontaneous breathing trial (SBT) weaning protocol. The study is designed to determine if automated ventilator controlled weaning can reduce total duration of intubation following mechanical ventilation in ICU patients requiring prolonged mechanical ventilation (\>72 hours).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Intubated with endotracheal tube
* Requiring mechanical ventilation for \> 72 hours
* Meets weaning criteria: Improvement or resolution of the underlying process that precipitated need for mechanical ventilation, PaO2 ≥ 60 mm Hg on PEEP and FiO2 Requirements of ≤ 8 cm H2O and FiO2 ≤ 0.50, Stable oxygenation: PEEP and FiO2 requirements not increased in the past 24 hrs, Ability to initiate an inspiratory effort and trigger the ventilator, Subject enrollment approved by the primary service attending physician

Exclusion Criteria:

* Pregnancy
* Patients with tracheostomy or planned tracheostomy prior to attempt to extubate
* Patients with known airway patency issues that are anticipated to delay extubation.
* Patients with neurological injury in whom care is likely to be withdrawn
* Patients with cervical spinal cord injury.
* Prospective subject or surrogate consenter does not fully understand the implications of the study because of a language barrier.
Safety and Tolerability Study of COVA322 in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis

This study is a randomised, double-blind, placebo-controlled, sequential, ascending single-dose, parallel group study to evaluate safety, tolerability, biological activity, and systemic exposure of COVA322 (tumor necrosis factor alpha (TNF-α) / interleukin 17 A (IL-17A) antibody fusion protein) in patients with stable chronic moderate-to-severe plaque psoriasis. Patients will receive ascending single-doses of COVA322 or placebo as a constant-rate i.v. infusion, followed by 12 weeks of evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of any ethnic origin; women must be of non-childbearing potential
* Aged between 18 to 65 yrs inclusive
* Body weight of ≥ 40 kg and body mass index between 19 - 32 kg/m2 inclusive
* Established diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criteria:
* Psoriasis involving ≥ 10% of body surface area
* Requirement of phototherapy or systemic therapy
* Psoriasis Area and Severity Index (PASI) score of ≥ 10
* Physician"s Global Assessment (PGA) score of ≥ 3
* stable disease

Exclusion Criteria:

* History of clinically relevant allergies or idiosyncrasies to COVA322
* Any history of clinically significant drug hypersensitivity following any therapy with a therapeutical biologic, or asthma, urticaria, or other allergic diathesis
* Clinically significant flare of psoriasis during the 12 weeks before randomization
* Current evidence of non-plaque forms of psoriasis
* Currently evidence of drug-induced psoriasis
* Evidence of any serious systemic or local infection within 3 months before screening
* Evidence of subclinical/latent tuberculosis infection
* History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years
* History or current evidence of autoimmune diseases other than psoriasis
* Women of child-bearing potential
* Recent previous exposure to systemic psoriasis treatments, including anti-TNF-α therapies, immunosuppressive agents such as cyclosporine, mycophenolate, or tacrolimus, and other medications affecting the immune function
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 2.5 times the upper limit of normal (ULN) at screening
* Serum creatinine level ≥ 1.5 times the ULN at screening
* Positive results in any of the virology tests for HIV-Ab, hepatitis C-virus antibody (HCV-Ab) and hepatitis B-virus surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
Preoperative Ultrasonographic Evaluation of the Right Common Femoral Vein Diameter for Predicting Spinal Anesthesia-induced Hypotension in Elderly Patients

In this study we will determine the ability of preoperative ultrasonographic evaluation of the right common femoral vein diameter to predict spinal anesthesia-induced hypotension in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or more.
* ASA score I \& II.
* Patients scheduled for surgeries under spinal anesthesia.

Exclusion Criteria:

* Negative consent.
* pre-existing hypertension
* Diabetes mellitus or autonomic neuropathy.
* Emergency operations.
* Absolute contraindications or failure to perform spinal anesthesia.
Cystic Fibrosis- Children and Adults Tai Chi Study

Cystic fibrosis (CF) is a progressive disease. Symptoms include coughing, poor lung ventilation, recurrent infections, poor weight gain, diarrhoea, malnutrition, stress, frustration, depression, irritability, worry, insomnia, behavioural issues and missed school/work.

Tai chi, a Chinese form of exercise, uses slow choreographed movements, breathing exercises and mindfulness. Research suggests tai chi can improve physical and emotional wellbeing for various chronic conditions.

This study compares methods of teaching tai chi to 70 people with CF, and evaluates the effect on symptoms and quality of life. Adults and children with CF will be recruited and randomly allocated to an intervention group or a control group. The former will receive 8 individual face to face sessions of tai chi over a 3 month period and a video and handouts to aid home practice. The latter will have routine care for the first 12 weeks, followed by 8 individual online sessions of tai chi over a 3 month period, and a video and handouts for home practice.

Both groups will be encouraged to practice tai chi at home in the months following the taught sessions.

Questionnaire data on how participants and their carers are coping with CF, any general improvements in wellbeing, and differences in other clinical outcomes (medication etc.)will be collected. Data will be collected at the beginning and end of the intervention, and at 6 and 9 months post intervention and differences between the 2 groups compared over time.

Feedback from on line focus groups will ask about their experiences, feasibility of learning and practicing of tai chi, engagement with the process, perceived health impact, and experiences of participation.

It is hoped that the study may show how Tai Chi can help people with CF to maintain their health through mindful exercise, and improve troublesome symptoms like sleep and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CF
* no previous experience in Tai Chi, but ability/potential to undertake these movements
* able to commit to a 9 month study
* living in or near London or Brighton (depending on teacher locations)
* able to understand, read and write English
* 6 years old and above
* to have internet access for web based learning

Exclusion Criteria:

* participant in the feasibility phase
* currently taking part in another interventional research study
Kinesio Taping for Balance and Function in Low Back Pain

This study aims to examine the effects of kinesiology taping on balance and functional ability in individuals with nonspecific low back pain. Nonspecific low back pain is a common condition that is not linked to a specific medical cause and is often associated with balance problems, reduced physical function, and psychological challenges. In this study, 35 patients aged between 18 and 65 were included. One group received kinesiology taping along with physiotherapy, while the other group received only physiotherapy.

Nonspecific low back pain (NSLBP) is a common musculoskeletal condition that cannot be attributed to a specific pathology. It often leads to limitations in functional activities, impaired balance, and psychological distress, such as depressive symptoms. This study investigates the effects of kinesiology taping on balance and functional outcomes in individuals diagnosed with NSLBP.

The study was conducted on 35 participants aged 18 to 65 years. Participants were randomly assigned to two groups: the intervention group received kinesiology taping in combination with physiotherapy, while the control group received only physiotherapy treatment. Various outcome measures were used to assess the effects of the interventions, including the Visual Analog Scale (VAS) for pain intensity, Functional Rating Index (FRI), Modified Oswestry Disability Index (MODI), Beck Depression Inventory (BDI), Nottingham Health Profile (NHP), and the Flamingo Balance Test.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years
* Diagnosis of nonspecific low back pain
* Duration of low back pain longer than 6 weeks
* Ability to attend an outpatient physiotherapy program

Exclusion Criteria:

* History of spinal surgery
* Presence of neurological deficits on physical examination
* Contraindication to kinesiology taping
* Pregnancy
* Cardiovascular or pulmonary diseases that contraindicate exercise
* History of lower extremity surgery
Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients

A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* ATG-F administration to prophylaxis rejection in kidney transplantation recipient.
* Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients.).
* Subjects with bacterial, viral, mycotic or parasitic infections, which are not under adequate therapeutic control.
* Solid organ transplant subjects with severe thrombocytopenia, i.e. less than 50,000 platelets/µl because ATG-F may enhance thrombocytopenia and thus increase the risk of hemorrhage.
* Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully.
* Subject is receiving a Human Leukocyte Antibody (HLA) identical living donor organ.
* Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.
A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 2 diabetes
* Drug Naive
* HbA1c \>= 7.0% and \<= 10.0%
* Body Mass Index \<= 41 kg/m2
* Serum TG \<= 600 mg/dL

Exclusion Criteria:

* Symptomatic Type 2 diabetes
* History of bladder cancer
* History of Myocardial Infarction (MI), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, Transient Ischemic Attach (TIA), or Cerebrovascular Accident (CVA) within 6 months, congestive heart failure (NYHA Class II and IV), uncontrolled hypertension, history of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.