cyrilzakka/clinical-trials huggingface dataset:
Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy

The main aim of this project is to improve waiting periods for specialised psychotherapy. We will apply a brief, smartphone-based self-efficacy training to patients with psychiatric disorders waiting for specialised psychotherapy. Additionally, we will use Ecological Momentary Assessment (EMA) to assess mood, social contacts, and other parameters daily. We will investigate whether the training can improve self-efficacy and related constructs and if it can help reduce stress and waitlist drop-outs during waiting periods. Additionally, we will investigate if the self-efficacy training has a positive effect on motivation and therapeutical relationship regarding the subsequent therapy.

After a screening for eligibility, participants will be randomly assigned to intervention and control group. At baseline, participants attend a laboratory session where they are assessed for current psychiatric disorders and further relevant psychological variables. They will then either participate in the digital self-efficacy training combined with EMA (intervention group) or in EMA only (control group). Both will be conducted via a smartphone app. Subsequently, participants will be asked to fill in post questionnaires at three different time points: after having finished app usage, one month later, and after the beginning of the subsequent psychotherapy.


Eligibility Criteria:
Inclusion Criteria:

* psychiatric disorder
* age 18-65
* waiting for psychiatric assessment/treatment (being on waitlist)
* sufficient knowledge of the German language
* smartphone user
* internet access via smartphone
* internet access at home (laptop, tablet, or computer)

Exclusion Criteria:

* current intense psychotherapy
* acute suicidality
* acute psychotic symptoms
* substance addiction
Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Body mass index (BMI) for children (6 to 12 years): 15-20 kg/m\^2 (both inclusive)
* Body mass index (BMI) for adolescents (13 to 17 years): 18-25 kg/m\^2 (both inclusive)
* HbA1c (glycosylated haemoglobin) below 11.0% according to central laboratory results
* Current treatment with insulin at least twice daily

Exclusion Criteria:

* Any significant disease such as endocrine, hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes
* Receipt of any investigational product within the last four weeks
* Known or suspected allergy to trial products or related products
Efficacy of Antihistamine Dosing-up and add-on Treatment With H2-receptor Antagonist

A randomized open labeled trial to compare the efficacy of antihistamine dosing-up and add-on treatment with H2-receptor antagonist in patients with chronic urticaria

* For four weeks
* After the researcher confirms the selection / exclusion criteria on the baseline, the UAS, K-UCT, and CU-QoL are created and randomized from the subject.
* Receive UAS, K-UCT, and CU-QoL from the subject during the last visit to assess safety

Eligibility Criteria:
Inclusion Criteria:

* Adolescents and adults over 12 years
* Clinical diagnosis of chronic urticaria due to wheal reaction, itching, angioedema over 6 weeks
* Antihistamine 2 or 2 kinds of treatment for more than 2 weeks even if the symptoms are not controlled
* Those who do not have other chronic skin diseases

Exclusion Criteria:

* None
Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)

The purpose of this study is to evaluate the safety and efficacy of long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD\&HD in hypertensive patients in the routine clinical setting

This is a special drug use surveillance on long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD combination tablets) to evaluate in hypertensive patients in the routine clinical setting. Because the drug contains a diuretic (hydrochlorothiazide) , it is necessary to assess the safety, especially on serum uric acid. (the planned sample size is 3000).

The usual adult dosage is 1 tablet (4 mg/6.25 mg or 8 mg/6.25 mg as a candesartan cilexetil/hydrochlorothiazide) administered orally once daily. This drug should not be used as a first-line drug for hypertension treatment.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients

Exclusion Criteria:

(1) Patients with a history of hypersensitivity to ingredients of ECARD LD\&HD combination tablets, thiazides, or their analogues (e.g. sulphonamide derivatives such as chlortalidone) (2) Patients with anuria or patients under hemodialysis (3) Patients with acute renal failure (4) Patients with noticeably decreased Na and K levels in body fluids (5) Pregnant women or women planning to become pregnant

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A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects

This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.

This is a multi-centered, randomized, double-blind, placebo-controlled, ascending parallel-group study of the safety and tolerability of REGN88 in patients with rheumatoid arthritis who are receiving concomitant methotrexate.

This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will not begin until enrollment in Part B is complete.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an established diagnosis of Rheumatoid Arthritis
* Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks

Exclusion Criteria:

* Persistent chronic or current active infections
* Patients who have taken anakinra within 2 weeks
* Patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks
* Patients who have taken adalimumab within 6 weeks
* Patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab within 12 weeks
* Patients who have taken leflunomide or rituximab within 6 months
* Patients who have had prior treatment with tocilizumab or any other anti-IL-6 medication
* Significant arthritis or other medical condition that could interfere with study evaluations
* Participation in any clinical research study evaluating another investigational drug within 30 days
Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the percentage of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.


Eligibility Criteria:
Inclusion Criteria:

* Competent non-smoking adults between the ages of 18 and 40 for each series of tests.
* Subjects must understand and consent to be in the study.
* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

* Subjects who have any systemic disease at all.
* Subjects who do not understand the study and the risks.
* Smokers.
* Subjects who are pregnant.
* Subjects having either signs or history of peripheral ischemia.
* Others deemed ineligible by the clinical staff.
Focused Lung Ultrasound: A Prospective Cohort Study in General Practice

This is a prospective cohort study that describes focused lung ultrasound (FLUS) findings in patients presenting with symptoms of an acute lower respiratory tract infection (LRTI) in general practice in Denmark.

Ten general practitioners (GPs) will perform FLUS in addition to their usual care of adults presenting with symptoms of an acute LRTI where the GP suspects a community-acquired pneumonia (CAP). Eligible patients will consecutively be invited to participate during a two months' study period until each GP has included a total of ten patients. The GPs will register information about patients including age, gender, symptoms, clinical findings, results of any point-of-care test performed, if antibiotic treatment was prescribed and they will register information on FLUS performance and findings.


Eligibility Criteria:
Inclusion Criteria (GPs):

GPs who use PoCUS (Point-of-Care Ultrasound) at least once a week in general practice or out-of-hour services.

Inclusion Criteria (Patients):

Patients aged ≥ 18 years with acute cough (\< 28 days) and at least one other symptom of an acute LRTI and where the GP suspects CAP.

Exclusion Criteria (Patients):

* Previous antibiotic prescription for the current episode of acute LRTI.
* Patients not listed with the GP (no medical record available).
* The patient is not capable of understanding and signing informed consent.
* The patient does not wish to participate in the study.
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)


Eligibility Criteria:
Inclusion Criteria:

* Adults with histologically/cystologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma
* Radiographic evidence of at least one bone metastasis (or lytic bone lesion from multiple myeloma); ECOG performance status 0, 1, or 2
* Adequate organ function

Exclusion Criteria:

* Diagnosis of breast or prostate cancer
* Current or prior intravenous bisphosphonate administration
* Current or prior oral bisphosphonates for bone metastases, life expectancy of less than 6 months
* Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Opioid Free Anesthesia: What About Patient Comfort?

66 female patients undergoing breast cancer surgery were randomized in the Jules Bordet Institute, the Belgian oncology institute. One group received an opioid anesthesia, the other group an opioid free one. The hypothesis of this study was that opioid free anesthesia improves the postoperative quality of recovery of anesthesia.

Opioids used as part of balanced anesthesia have known undesired side effects such as: respiratory depression, post-operative nausea and vomiting, pruritus, difficulty voiding and ileus.

The purpose of this study was to determine whether opioid free anesthesia influences the quality of recovery. A multimodal approach combining ketamine, lidocaine and clonidine was used as an alternative for an opioid based anesthesia.

The hypothesis of this study was that patient comfort and satisfaction level after an opioid free anesthesia would be higher compared to after a more traditional opioid anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Oncological patients undergoing a total mastectomy or lumpectomy associated with a total axillary dissection were screened.
* Patients with an ASA physical status of II were included.
* Knowledge of either French, English or Dutch was required.

Exclusion criteria were the following:

* Allergy or contraindications to one of the study drugs, renal failure, hepatic failure, hyperthyroidism, AV block 2 or 3 or severe bradycardia, left ventricular failure, unstable blood pressure, epilepsy and psychiatric disturbance.
E-cigarette vs. Nicotine Inhaler Comparisons

The goal of this study is to get information from current smokers about how they feel towards both the electronic cigarette (e-cigarette) and the nicotine oral inhaler. This will include beliefs, harms, appeal, ease of use, enjoyment, and their use for helping people stop smoking.

Subjects will be seen at Baseline, then 3-days post-baseline, then 9 days post-baseline for post product use questionnaires and carbon monoxide monitoring. The time frame for follow up is 6 months post Baseline visit.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be smokers 18 years or older, who have had no previous experience with either the e-cigarette or the nicotine oral inhaler, and will be recruited from the local community. They can currently smoke any amount or frequency and with any level of motivation to stop smoking.

Exclusion Criteria:

* Exclusion criteria include recent (within 2 weeks) myocardial infarction or angina, poorly controlled asthma/chronic obstructive pulmonary disease , active substance abuse, pregnancy, or current use of any other cessation medications
Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02)

The purpose of this study is to find out what effects, good and/or bad, proton radiation at a higher tumor dose (and lower normal surrounding lung dose) combined with standard chemotherapy has on lung cancer. The dose you receive to the tumor will be higher than the standard dose. This may be able to increase the control of the tumor. Due to the accuracy of radiation given with protons, the dose to the normal lung tissue that surrounds the tumor will be lower than standard. This may be able to reduce the frequency and severity of the usual radiation side effects.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented non-small cell carcinoma of the lung diagnosed within 16 weeks prior to study enrollment.
* Patient must be at least 18 years old at the time of consent.
* Stage III A or III B disease.
* Patients must be able to start study treatment within 6 weeks of study enrollment.
* Induction chemotherapy is allowed.
* Marginally resectable or unresectable at presentation.
* If the patient had exploratory thoracotomy, it must be done at least 3 weeks prior to enrollment.

Exclusion Criteria:

* Evidence of distant metastasis.
* Prior thoracic radiotherapy.
* Any history of allergic reaction to taxanes.
* Prior tumor resection. Candidate for upfront curative surgery.
* Pleural effusion visible on chest x-ray or the scout view of the CT chest.
* Unintentional weight loss within the month prior to diagnosis ≥ 10%.
* Previous or concomitant malignancy other than early stage tumor treated more than 3 years ago for cure.
* The presence of PET positive contralateral hilar disease.
The Effect of Abdominal Binders on Patient's Wellbeing After Cesarean Delivery

The effect of abdominal binders on patient's wellbeing after cesarean delivery

The effect of abdominal binders on patient's wellbeing after cesarean delivery 12 hours and one week after cesarean section

Eligibility Criteria:
Inclusion Criteria:

any female post cesarean section of singleton 34 wks gestaion fetus with previous cs

Exclusion Criteria:

primary cs any hypertensive disorder with pregnancy any neurologiacal disease general anasthesia or vertical incision
Investigating the Association Between Central Sensitization and Breathing Pattern Disorders

Breathing pattern disorders can cause mechanical, physiological, and psychological issues in the body, contributing to the initiation and chronicity of pain. Therefore, considering breathing patterns is significant in managing chronic pain, yet direct research on central sensitization and breathing pattern disorders remains scant. This study aims to analyze the correlation between central sensitization and breathing pattern disorders in adults by assessing both respiration and pain.

Breathing pattern disorders impact consciousness and the body according to respiratory patterns, leading to physiological, mechanical, and psychological disturbances. Unlike normal breathing patterns facilitated by appropriate diaphragmatic activity, incorrect patterns often exhibit reduced diaphragmatic engagement. Chest breathing patterns are prevalent among chronic pain patients, characterized by limited upper chest segment movement due to prolonged improper respiration without specific pathological symptoms. Fluoroscopy studies reveal flattened and tense diaphragms with diminished relative mobility, implicating accessory and inspiratory muscles more heavily in ventilation. Biologically unsustainable functional breathing patterns correlate with chronic musculoskeletal issues and pain. Prior research establishes associations between inappropriate breathing patterns and chronic lower back pain and scapular dysfunctions. Consequently, managing chronic pain clinically necessitates functional recovery and pain relief, crucial for sustaining daily life. Therefore, researching central adaptations and respiration in chronic pain management is imperative, yet remains insufficiently explored.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and above.
* Individuals scoring 40 or above on the Central Sensitization Inventory for Koreans (CSI-K).
* Individuals who consent to the use and publication of their personal information and wish to participate in assessment measurements.

Exclusion Criteria:

* Individuals with pulmonary, cardiac, or respiratory diseases.
* Individuals with severe hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
* Individuals with cognitive impairments.
* Individuals who express a desire to withdraw from the study during its duration.
Glucose Homeostasis in Pseudohypoparathyroidism

It is increasingly recognized that Pseudohypoparathyroidism type 1A (PHP1A) is associated with an increased risk of type 2 diabetes but the mechanism is unknown. In this pilot study we will assess β-cell function in patients with PHP1A and pseudopseudohypoparathyroidism PPHP.

Pseudohypoparathyroidism type 1A (PHP1A) is a rare, genetic disorder caused by impaired stimulatory G-protein signaling due to heterozygous mutations in the gene, GNAS. The most severe form of the disease, PHP1A occurs when a GNAS mutation is inherited on the preferentially expressed maternal allele. A less severe form of the disease, pseudopseudohypoparathyroidism (PPHP), occurs when a GNAS mutation is inherited on the paternal allele. Clinically, PHP1A is characterized by multi-hormone resistance, cognitive impairment and early-onset obesity while PPHP has a mild phenotype without multi-hormone resistance. It is increasingly recognized that PHP1A is associated with an increased risk of type 2 diabetes but the mechanism is unknown. Glucose homeostasis and diabetes risk has not been studied in PPHP. As part of the parent K23 award, we investigated glucose tolerance in children with PHP1A. In contrast to the adult literature, we found that children with PHP1A had greater insulin sensitivity than matched controls. When challenged with an oral glucose load, however, children with PHP1A had persistent hyperglycemia and 25% met criteria for impaired glucose tolerance. The goal of this proposal is to quantify β-cell function in PHP1A. It is plausible that these individuals have a) impaired β-cell function, b) differences in insulin sensitivity, and c) impaired incretin function. Thus, in this pilot study we will definitively assess one of these, β-cell function, using the frequently sampled intravenous glucose tolerance test in patients with PHP1A and PPHP (aim 1). We will also assess oral glucose tolerance over time by bringing back children and young adults with PHP1A from our original cohort for repeat glucose tolerance testing (aim 2). The ultimate goal is to rigorously define glucose homeostasis defects in PHP1A in order to design and conduct an intervention study for glucose intolerance and type 2 diabetes in PHP1A.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of PHP1A/PPHP
2. Age between 6 and 50 years old

Controls will be matched based on:

1. Gender
2. Race
3. Age (±2 years if \<25 years old or ±5 years if ≥25 years old)
4. BMI (±2 kg/m2)
5. Diabetes status

Exclusion Criteria:

1. Treatment with appetite-altering drug or initiation of a new weight loss program in the past 3 months
2. Type 1 diabetes
3. Type 2 diabetes treated with insulin or GLP-1 receptor agonists or A1c \>9%at their most recent clinic visit
4. Pregnant or lactating women
Attachment, Patient Self-disclosure and Psychotherapy Outcome

This study investigates whether within- and between-patient effects of attachment moderate the association between self-disclosure and psychotherapy outcome.

Participants are recruited at the University Clinic Heidelberg at the beginning of their (usually) 8-week inpatient treatment. After informed consent, patients routinely fill out weekly questionnaires on attachment, self-disclosure, and symptom severity.

This study is the first to disentangle stable, trait-like (between-person) effects of both attachment and self-disclosure from within-person changes over the course of treatment. The study investigates whether (changes in) attachment moderate the association between (changes in) self-disclosure and psychotherapy outcome.

Eligibility Criteria:
Inclusion Criteria:

* patients of at least 18 years of age
* treated at the inpatient unit of a hospital for psychosomatic medicine
* provided measurements of symptoms, attachment style, and self-disclosure for at least one measurement occasion

Exclusion Criteria:

* bipolar, acute psychotic or substance abuse disorders