cyrilzakka/clinical-trials huggingface dataset:
Orthorexia Nervosa in Postmenopausal Osteoporosis

A total of 64 female patients diagnosed with osteoporosis based on dual-energy X-ray absorptiometry (DXA) measurements performed within the last six months, and 64 age-matched healthy controls without osteoporosis, will be included in our study. Sociodemographic data such as age, sex, height, weight, and BMI will be recorded. Additionally, information regarding the duration of osteoporosis diagnosis, current treatments, history of fractures, history of falls, comorbidities, and smoking status will be collected. Femoral neck and L1-L4 T-scores and bone mineral density values obtained from existing DXA scans will be documented. Orthorexia nervosa-related symptoms will be assessed using the ORTO-11 scale, mood will be evaluated using the Hospital Anxiety and Depression Scale (HADS), and body image will be assessed using the Body Appreciation Scale-2.


Eligibility Criteria:
Inclusion Criteria:

* Women between 55-75 years
* Women diagnosed with osteoporosis based on DXA measurements performed within the past six months.
* Women aged similarly to the osteoporosis group without a diagnosis of osteoporosis (healthy controls).
* Willingness to participate and provision of written informed consent.

Exclusion Criteria:

* Refusal to participate in the study.
* Diagnosed psychiatric disorders.
* Cognitive impairment.
* Presence of malignancy.
* Presence of endocrine disorders (e.g., hyperthyroidism, Cushing's syndrome).
* Use of glucocorticoids.
* Use of medications affecting mood.
Melatonin Treatment After Laparoscopic Cholecystectomy

Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and general wellbeing.

Postoperative fatigue and sleep disturbances occur after minimally invasive surgery. The pathophysiological background is unknown, but several studies have shown disturbed melatonin secretion after surgery. It is unknown whether melatonin substitution will improve general wellbeing, fatigue or sleep disturbances after laparoscopic cholecystectomy. We set out to study in a randomized clinical trial to investigate the effect of 5 mg melatonin versus placebo, on postoperative sleep disturbances, fatigue and general wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Operation for gall bladder disease
* Age over 18 years

Exclusion Criteria:

* Known preoperative sleep disturbance
* Anticoagulant therapy
* Psychiatric disease
* Lack of written informed consent
* Treatment with hypnotics within one week prior to surgery
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy

The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria
2. Patients aged ≥16 to \<65 years at the time of obtaining informed consent
3. Outpatients

Exclusion Criteria:

1. Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome, periodic limb movement disorder)
2. Patients with organic brain diseases (including neurodegenerative diseases or cerebrovascular disorders) or epilepsy
3. Patients with obstructive respiratory diseases (bronchial asthma, emphysema)
4. Patients with psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia)
A Phase 1 Study of CNTO 3157 in Healthy Volunteers and Patients With Asthma

This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.

A phase 1, randomized (study drug assigned by chance), double blind (neither physician nor patient knows if CNTO 3157 or placebo has been assigned), placebo controlled, single, ascending-dose study of CNTO 3157 in healthy volunteers and multiple dose study in patients with asthma. This study will compare the effects (both good and bad) of CNTO 3157 to those of placebo. The purpose of this study is to evaluate the safety and potential side effects of CNTO 3157 given to healthy volunteers and patients with asthma. In addition, the investigators will measure how much study drug is in the blood following a dose of CNTO 3157, and determine if the body makes antibodies to it. (An antibody is a protein made by the body in response to a foreign substance). Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. There will be 2 parts to this study. The first part of this study will involve healthy volunteers, and the second part of the study will involve patients with asthma. About 56 healthy volunteers and 16 asthmatic patients will take part. Volunteers will be required to stay at the research center after study agent administration for an inpatient portion of the study and then return for required out-patient visits. Up to approximately 8 different dose levels will be studied. CNTO 3157 will be administered by IV infusion. The duration of volunteer participation will be up to 21 weeks in Part 1 and up to 24 weeks in Part 2.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female between 18 and 55 years of age inclusive with no clinically significant abnormalities and have a body weight of 50 to 100 kg
* Patients with asthma must have been diagnosed at least 6 months prior to participation in the study

Exclusion Criteria:

* Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, immune deficiency state, respiratory disease (other than asthma for Part 2), hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
* Have a positive pregnancy test at screening or prior to dose administration
* Have smoked tobacco or related products within 6 months prior to dosing
* Donated blood equal to or greater than ¿450 mL within 60 days prior to participation in the study
* Recent history (within previous 6 months) of alcohol or drug abuse
Acellular Dermal Matrix in Breast Reconstruction

Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls reconstructions. However, it is solely used in breast reconstructions after breast carcinoma amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to current treatment options, however, this has to be proved.

This is a prospective study, where patients undergoing breast reconstruction surgery using acellular dermal matrix (ADM) with expander use in first phase of reconstruction will be included. The permanent breast implants will be implanted approximately half year during second surgery. Acellular dermal matrix is a soft tissue graft that is formed by decellularization, however with intact extracellular dermal matrix. Such structure is able to re-create adequate skeleton for host cells with subsequent incorporation and revascularization. The safety and appropriateness of such ADM in breast reconstruction surgery will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* total one-side mastectomy due to breast cancer
* age between 18-60 years

Exclusion Criteria:

* failure to obtain signed informed consent
A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma

The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.

The purpose of this phase III study is to evaluate the clinical benefit of liso-cel for the treatment of r/r FL by comparing it to standard of care therapy in patients with r/r FL, with progression-free survival (PFS) as the primary endpoint.

The primary objective is to demonstrate superiority of the Liso-cel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by independent review committee (IRC) based on the Lugano response criteria.

Participants randomized to Arm A (Standard of Care) will receive RCHOP, BR, or R2 based on investigator choice and this has to be determined prior to randomization.

Participants randomized to Arm B (Liso-cel treatment) will receive a single infusion CAR-positive viable T-cells.

Eligibility Criteria:
Inclusion Criteria

* Participants must have measurable disease.
* Participants must have previously been treated with certain defined anti-cancer therapies and their disease must have come back or must have not responded to the previous or last treatment.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participants that have histologically confirmed Follicular Lymphoma (FL) (Grade 1, 2, or 3a) corresponding to the most recent relapse prior to screening.
* Participants that have Relapsed or refractory FL, as assessed by the Investigator.
* Participants that have received at least one prior line and no more than three prior lines of systemic therapy including a combination of an anti-CD20 antibody and an alkylating agent.
* Participants that received one prior line of systemic therapy are eligible if they present with high risk features.

Exclusion Criteria

* Participants must not have any history of heart problems.
* Participants must not have any bleeding disorders.
* Participants must not have any Central Nervous System involvement by Follicular Lymphoma or other brain conditions.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Cardiovascular Fellow-in-training Feedback on Virtual and Simulator-based Learning Experience in A Low to Middle Income Country

Virtual and simulatorbased learning is not widely available in LMIC. It is imperative to analyze feedback of CV fellow-in-training regarding this mode of learning before large scale implementation.

COVID-19 pandemic has introduced us to a greater need of virtual learning platforms and has resulted in less clinical exposure for fellows-in-training. Virtual and simulatorbased learning is not widely available in LMIC. It is imperative to analyze feedback of CV fellow-in-training regarding this mode of learning before large scale implementation.

This was an observational study conducted between July-August 2020. A multicentered survey was conducted. Survey questionnaire was disseminated to FIT via Google Forms. The questionnaire contained total of 24 questions about virtual and simulator-based learning during the pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Cardiovascular fellow-in-training currently under training at the institute.

Exclusion Criteria:

* None.
Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations

The purpose of this study is to determine whether participation in mind-body skills groups by veterans who have experienced a stressful war-related situation and have symptoms of posttraumatic stress disorder (PTSD), will improve symptoms of PTSD, depression and anxiety, reduce anger, improve quality of life, quality of sleep and result in posttraumatic growth (a positive change that people can experience when they have been in a traumatic situation).

The study will be a randomized controlled study where participants will be randomly selected to either participate in the mind-body skills program and to answer questionnaires before and after the program and again 6 months later or, if they are not randomized to the mind-body skills group program, they will answer the questionnaires during the same time periods without participating in the program. Both groups will also continue their medical treatment as usual. The mind-body skills group intervention consists of groups of 8-10 participants. Two formats will be offered. (1) A 2 hour group session once a week for 10 weeks or (2) Weekend groups which will be run on alternating Saturdays, with a 2 hour session in the morning and another 2 hour session in the afternoon. The groups will be run for a total of 5 Saturday sessions. Additional "reunion" groups will be held at 1 month, 3 months, and 6 months in order to reinforce skills and to provide continuing social support.

Eligibility Criteria:
Inclusion Criteria:

* having experienced a deployment-related criterion A stressor and reporting post deployment stress symptoms which include: clinically diagnosed posttraumatic stress disorder (PTSD), or subthreshold PTSD symptoms
* comorbid conditions may also include mild traumatic brain injury, or clinically significant levels of depression or anxiety.

Exclusion Criteria:

* current uncontrolled psychotic or bipolar disorder
* significant cognitive impairment
* moderate or severe TBI
* substance dependence
* suicidal or homicidal ideation
Impact of Gastroesophageal Reflux and Aspiration on Airway Inflammation and Microbiome in Children With Chronic Cough

Using an active cohort of children in whom Airway and gastrointestinal endoscopy will be performed, investigators will conduct a chart review to obtain relevant clinical data and the investigators will use an aliquot of airway sample obtained during the clinically indicated bronchoscopy for microbiome analysis. A case-control study design will be used to study whether subjects with CC with GER have a distinct lung microbiome and increased inflammation as compared with subjects with CC without GER and to determine whether the microbiome and degree of inflammation is related to the type of GER (acidic versus nonacidic).


Eligibility Criteria:
Inclusion Criteria:

* Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (\>4weeks).

Exclusion Criteria:

* Antibiotic or steroids (inhaled or systemic) use within the prior one-week. Rationale: Antibacterial drugs and immune-modulators are confounders that may impact the microbiome and inflammation. While longer period free of Antibacterial drugs and immune-modulators would be desired, it would be unethical and it is not the usual standard of care to withdraw treatment for longer periods of time.
* Interstitial Lung Disease or pneumonia on X-ray
* Cystic fibrosis
* Primary ciliary dyskinesia
* Immunodeficiency syndromes
* Major airway abnormalities
* Proton pump inhibitor/H2-receptor antagonist therapy within the prior 2 weeks
Control and Burden of Asthma and Rhinitis

An observational cross-sectional study will include 750 individuals of all ages, divided in 4 groups: 1) Patients with a self-reported diagnosis of asthma alone (n=150), 2) Patients with a self-reported diagnosis of rhinitis alone (n=150), 3) Patients with a self-reported diagnosis of asthma and rhinitis (n=150) and 4) Patients with no history of respiratory symptoms or diseases (n=300)

During 2010, we've conducted two cross-sectional, telephonic national surveys that assessed the prevalence (Portuguese Asthma Prevalence Survey - PAPS) and the control (Portuguese Asthma Control Survey - PACS) of asthma and rhinitis. Before these surveys there was no country-wide data on prevalence or about the control of asthma in Portugal.We propose an additional study that will apply a comprehensive set of diagnostic tests and clinical assessment to a sub-sample of participants in the PACS study. The effect of asthma, rhinitis and their control on personal and social burden will be studied comparing patients with current asthma and/or rhinitis and individuals with no respiratory symptoms.Sample size calculations were based on the comparison of quality of life measured by WHOQOL-BREF in patients with different diagnosis. Data collection includes anthropometric measurements, lung function \& inflammation tests, allergy tests, a structured clinical interview and standardized questionnaires. Research assistants performing the evaluations will be blinded to the subject classification in PAPS and PACS and to the results of the questionnaires administered, namely the GA2LEN survey instrument and CARAT. The data collection will be organized with the local Public Health delegate and will take place as close as possible to the participants' communities at a local health unit or in the surrounding area, in order to minimize dropouts.

Eligibility Criteria:
Inclusion Criteria:

All subjects that were included in PACS and that have expressed their willingness to participate in a clinical assessment of asthma.

New participants that have medical diagnosis of asthma, rhinitis, or are healthy.

Exclusion Criteria:

Persons who don't understand spoken portuguese. Persons who have cognitive or physical conditions thta could hamper their participation in the study.
Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants with EPP

This is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of DISC-1459 in participants with EPP.


Eligibility Criteria:
Inclusion Criteria:

* Participants with diagnosis of EPP who are participating (or who have participated) in a prior Disc Medicine bitopertin study and who have completed the randomized treatment phase and End-of-Study visit
* Aged ≥12 years upon study consent
* Body weight ≥32 kg for participants \<18 years of age and BMI ≥18.5 kg/m2 for adult participants

Exclusion Criteria:

* Participants who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bitopertin
* Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgement of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude participation in the study
* Condition or concomitant medication that would confound the ability to interpret clinical, clinical laboratory, or participant diary data, including a major psychiatric condition that has had an exacerbation or required hospitalization in the last 6 months
* Planned treatment with afamelanotide or dersimelagon during the study
* Planned use of any drugs or herbal remedies known to be strong inhibitors or inducers of cytochrome p450 (CYP)3A4 enzymes throughout the study
* If female, pregnant, or breastfeeding
* Participation in any other clinical protocol or investigational trial, other than Disc Medicine bitopertin trials, that involves administration of experimental therapy and/or therapeutic devices within 30 days of Day 1
* Score of PHQ-8 ≥10 at screening or imminent suicidal risk identified by the C-SSRS as defined as suicidal ideation with intent (Grade 4 or 5) within the last year or any suicidal behavior within the last 5 years.
* Consumption of grapefruit/Seville orange and products containing these for 14 days prior to first dose of study drug and throughout the study
Monitoring and Treatment of Extremity Trauma for Mass Casualties in Difficult Contexts

The prospective cohort study, SuTra2, assesses the functional and socio-economic status of patients who were operated on for a severe limb injury resulting in amputation or limb preservation 1 and 2 years after the 2010 Haiti earthquake.


Eligibility Criteria:
Inclusion Criteria:

* Patients, with limb injuries due to the earthquake,
* Who underwent limb surgery, which ended up in limb amputation or limb conservation.

Exclusion criteria :

* Limb injury not related to the earthquake
* No surgery for the limb injury
Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery

The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early following cardiac surgery.

Cardiac surgery is a major surgical procedure used to treat for example coronary artery disease (CAD). The intervention increases survival rates and reduces cardiac symptom burden in cardiac patients. However, cardiac surgery is associated with elevated symptoms of psychological distress, which are related to several negative outcomes, such as poorer health-related quality of life (QoL) and response to treatment. There is a clear need to develop a brief psychological intervention that can be provided early in the clinical course after cardiac surgery to reduce psychological distress.

The purpose of this pilot study is to evaluate the feasibility and potential efficacy of a brief, exposure-based internet-delivered CBT protocol provided early after cardiac surgery. This is an uncontrolled pilot study with a pretest-posttest design. The study will include 30 participants. Assessments will be conducted pre-treatment, post-treatment, one- and six months after treatment. The one-month follow-up is the primary endpoint.

The treatment lasts for five weeks and will be provided as an early intervention following cardiac surgery ≥ eight weeks to nine months before assessment. It will include psychoeducation, behavioral activation to address post-operative fatigue and depression, interoceptive exposure to reduce fear of cardiac-related symptoms and in-vivo exposure to reduce avoided situations, and activities to enhance physical activity and wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* (A) Cardiac surgery (i.e., CABG, heart valve repair/replacement, aortic repair or combined CABG and valve repair/replacement) ≥ eight weeks to nine months before assessment
* (B) Age 18 years and above;
* (C) Endorses postoperative psychological distress and/or interference with daily life
* (D) On medical treatment for the cardiac condition according to clinical guidelines;
* (E) Ability to read and write in Swedish

Exclusion Criteria:

* (F) Prior cardiac surgery with ventricular assist device or heart transplant;
* (G) Hospitalized or living in a care facility;
* (H) Any medical restriction to be physical active;
* (I) Severe medical illness i.e., terminal cancer ;
* (J) Severe psychiatric disorder or risk of suicide;
* (K) Alcohol dependency;
* (L) Ongoing psychological treatment.