cyrilzakka/clinical-trials huggingface dataset:
Cukurova University Faculty of Medicine Non-interventional Clinical Research Institutional Ethics Committe

This research was carried out to determine the effect of therapeutic touch on sleep quality and fatigue in menopausal women.

Methods: This randomized controlled experimental study was conducted with 48 (24 in the intervention group and 24 in the control group) women who sought treatment in the gynecological outpatient clinic of a public hospital. According to the study procedure, while the intervention group received therapeutic touch, the control group received SHAM therapeutic touch for 10 minutes a day for five consecutive days. Data were collected through the Personal Information Form, the Pittsburgh Sleep Quality Index, and the Piper Fatigue Scale.

Results: The median post-test total sleep quality score was significantly lower in the intervention group than in the control group (p=0.010). However, the mean total fatigue scores did not differ significantly between the groups (p=0.917).

Conclusions: The results of this study showed that therapeutic touch was effective in improving sleep quality, but it did not affect fatigue in menopausal women.

Eligibility Criteria:
Inclusion Criteria:

The study included women who agreed to participate in the study, lived in the city center, were at least literate, were in the natural premenopausal (irregular menstrual cycle within the last three months), perimenopausal (amenorrhea for 3-11 months or increased irregular menstruation), or postmenopausal (amenorrhea for more than 12 months) periods, were open to communication and cooperation, and could speak Turkish.

Exclusion Criteria:

The women who received hormone replacement treatment, used drugs for sleep problems and depression, were diagnosed with a medical psychiatric disease, and had sensitivity or problems about touching were excluded.
Imaginal Exposure for Hoarding Disorder

The present study will test a potential new treatment strategy, imaginal exposure, for hoarding disorder. Although cognitive behavioral therapy often reduces hoarding, some people do not want to start, or cannot handle, that option. To help such individuals, the present study will provide imaginal exposure therapy to people with hoarding disorder, wherein they imagine discarding possessions as a way of becoming acclimated to the idea. We predict that imaginal exposure will improve hoarding symptoms as well as two psychological experiences linked to the condition: intolerance of uncertainty and emotional avoidance.

Hoarding disorder is a common mental illness characterized by difficulty parting with possessions and by clutter that makes living spaces unusable. Cognitive behavioral therapy (CBT) is an effective treatment for hoarding disorder, but new approaches are needed to engage those who are reluctant to start or cannot tolerate CBT. Both intolerance of uncertainty and emotional avoidance are linked to hoarding disorder and may interfere with treatment engagement. Imaginal exposure, a therapeutic technique which involves repeatedly imagining feared scenarios and experiencing the evoked emotions, effectively targets both intolerance of uncertainty and emotional avoidance. The present study is the first to test whether imagining discarding possessions can improve hoarding symptoms more than does a control exercise. We hypothesize that compared to a control exercise, imaginal exposure will improve hoarding symptoms, intolerance of uncertainty and emotional avoidance.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older
2. Any gender and all ethno-racial categories
3. Hoarding Disorder primary condition
4. Willing and able to understand and complete consent and study procedures
5. English speaking

Exclusion Criteria:

1. Severe depression
2. Clinically at risk of suicide with Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Subscale of 4 or higher (i.e. suicidal intent without specific plan)
3. Currently receiving Cognitive Behavioral Therapy (CBT)
Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection

Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients, and both immunological and clinical responses have been observed. For these therapies accurate delivery to target organs is essential. Correct delivery and subsequent migration of vaccinated DCs to regional lymph nodes is of paramount importance for effective stimulation of the immune system. Currently it is not known what the best route of administration is for DC vaccines.

Using magnetically labeled DCs, we investigate the potential of MRI cell tracking to monitor DC therapy. This is investigated in stage III/IV melanoma patients in whom a regional lymph node dissection is scheduled. Autologous monocyte-derived DCs are labeled with the clinically approved superparamagnetic iron oxide (SPIO) formulation Endorem and 111In-oxine and injected either in the skin or directly in lymph nodes under ultrasound guidance. Two days after vaccination patients are monitored with scintigraphy and MR imaging. Lymph nodes are then resected. Subsequently patients receive 3 more vaccination with DCs. During and after therapy immune responses against the used melanoma peptides are monitored.


Eligibility Criteria:
Inclusion criteria:

Histologically documented evidence of melanoma

Stage III-IV melanoma according to the 2001 AJCC criteria

Radical lymph node dissection planned, either with curative (stage III) or palliative (stage IV) intent

Melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)

HLA-A2.1 phenotype according to lymphocyte HLA typing

ECOG performance status 0-1, life expectancy \> 3 months

Age 18-75 years

Interval since last prior chemotherapy, immunotherapy or radiotherapy at least 4 weeks, no residual toxicity of prior treatment.

WBC \> 3.0 x 109/l, lymphocytes \> 0.8 x 109/l, platelets \> 100 x 109/l, serum creatinine \< 150 μmol/l, serum bilirubin \< 25 μmol/l

Written informed consent

Expected adequacy of follow-up

Exclusion criteria:

No clinical signs of CNS metastases, in patients with a clinical suspicion of other metastases diagnostic tests should be performed to exclude this.

No concomitant use of corticosteroids or other immunosuppressive agents

No history of second malignancy within the last 5 years. Adequately treated basal carcinoma of skin or carcinoma in situ of cervix is acceptable within this period

No serious concomitant disease, no active infections. No autoimmune disease or organ allografts, no clinical suspicion of HIV or Hepatitis B

No contra-indications for MRI-scanning: claustrophobia, pacemaker or pacemaker threads, cerebral clips or artificial heartvalves, internal hearing prosthesis No known allergy to shell fish (contains KLH)

No pregnant or lactating women
A Single-center, Prospective Cohort Study on the Differentiation of Benign and Malignant Bile Duct Stenosis Based on Bile and Peripheral Blood cfDNA Methylation Profiles

The goal of this observational study is to detect the methylation characteristics of cfDNA in the bile and plasma of patients with bile duct stricture. The main question it aims to answer is: Can the developed model, using peripheral blood and bile cell-free DNA sequencing, work well in screening and classifying unknown biliary stricture? Participants will collect approximately 10ml of peripheral blood and 5ml of bile from the patient.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with biliary stricture aged between 18 and 90 years old.
* 2. Patients scheduled to undergo ERCP surgery due to obstructive jaundice or cholangitis.
* 3. Definite benign or malignant diagnosis: with a pathological diagnosis of benign or malignant disease, or with follow-up data indicating a benign or malignant diagnosis.

Exclusion Criteria:

* 1. Receive radiotherapy, chemotherapy, or targeted therapy before sampling.
* 2. Malignant tumors in other parts of the body (not related to biliary stricture).
* 3. Unable to determine the nature of the biliary stricture.
* 4. Ineligible for ERCP due to systemic conditions or gastrointestinal obstruction.
* 5. Pregnant or breastfeeding women.
* 6. Unable to sign the informed consent form.
Articulated Laparoscopic Instruments Clinical Study

Recently, with the development of minimally invasive surgery and the development of instruments, laparoscopic and robotic surgery are increasing, and laparoscopic and robotic surgery are evolving. The association between the new surgical instruments used in each upper gastrointestinal surgery and the results has been traditionally analyzed through the learning curve, and in addition, the study aims to collect and analyze the utilization of the instrument and surgical results prospectively through surgical video analysis.

Prior to surgery, all patients subject to the study are explained and informed of the prior consent form of prior consent is delivered. During surgery, video recording is performed to check the type of surgical instrument, the time of use, and the event that occurred during surgery. After surgery, the morbidity after surgery will be monitored and recorded. Additional morbidity will be recorded one to three months after surgery.

Eligibility Criteria:
Inclusion Criteria:

Patients with gastric cancer shcedulled for gastrectomy

Exclusion Criteria:

Vulnerable subject (illiterate, pregnant)
PICNIC Study - PatIent Centered ANtIbiotic Courses in Children with Medical Complexity

To determine if clinicians can safely reduce antibiotic exposure in children with medical complexity (CMC) who are diagnosed with pneumonia by implementing an intervention that bases total antibiotic duration on an individual's clinical stability.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the Complex Care Service at Boston Children's Hospital with a provider diagnosis of pneumonia
* Started on antibiotics by the provider team
* Ages 2-25 years old

Exclusion Criteria:

* Patients initially admitted to the intermediate care unit or ICU due to increased respiratory support needs
Surgical and Conservative Treatment in Isolated Minor Rib Fractures

The purpose of this research is to compare the outcomes of surgical stabilization and conservative treatment in patients with isolated minor rib fractures.

Isolated minor rib fractures (IMRFs), which is defined by single or two isolated minor rib fractures caused by trauma or stress. Traditionally, rib fractures are managed mainly by surgical stabilization or conservative treatment. In 2018, a systemic review and meta-analysis for patients with multiple rib fractures had revealed a shorter duration of mechanical ventilation, shorter hospital length of stay, and fewer trauma-associated complications in the surgical group than in the non-surgical group. In contrast, IMRFs are seldom life threatening, and compared to extremity fractures, rib fractures do not require matching accurately. Thus, IMRFs are usually treated conservatively. However, the investigators have clinically observed that patients suffering severe pain due to progressive rib displacement may take longer to return to normal activity, have lower quality of life, and even an increased risk of complications. Moreover, limited studies discussed the efficacy of surgical interventions for IMRFs. Therefore, the investigators conduct a prospective observational cohort study to compare the outcomes of surgical stabilization and conservative treatment in patients with IMRFs. The investigators collect patients with IMRFs whose situation were both suitable for surgical and non-surgical interventions. After explanation, patients can decide to undergo conservative or surgical treatment by themselves. The investigators will follow up pain scores, chest X-ray, pulmonary function tests, and duration of return to normal activity. Those data will be statistically analyzed by two-tailed two-sample t-test. This prospective cohort study is supposed to provide more evidence for clinical decision making and optimal management of IMRFs.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 20 years old.
* Patient was diagnosed with isolated minor rib fractures by thoracic surgeon.
* Patient was suitable for both surgical stabilization and conservative treatment.

Exclusion Criteria:

* Severe trauma associated to other systems.
* Pathologic fractures: such as fracture due to metastasis or steroid therapy.
* Unconsciousness or disturbed conscious level.
Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.

The study will include approximately 200 patients with suspected biochemically recurrant prostate cancer. Each patient will be administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 minutes post copper Cu 64 PSMA I\&T injection.

The PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and scored for the detection of prostate cancer. Specifically, each reader will categorize images as "Disease" or "No Disease" based only on tumor uptake of copper Cu 64 PSMA-I\&T. Analysis of the reads will be used for determination of the patient-level correct detection rate and region-level correct localization rate of copper Cu 64 PSMA I\&T PET/CT by comparison to the Reference Standard.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven prostate adenocarcinoma.
* Prior radical prostatectomy (greater than 6 weeks prior to screening) or radiation therapy (greater than 1 year prior to screening) with curative intent.
* Recurrence of disease defined as:

  1. Prior radical prostatectomy: PSA greater than or equal to 0.2 ng/mL followed by subsequent confirmatory PSA value greater than or equal to 0.2 ng/mL or
  2. Prior radiation therapy: 2 ng/mL rise in PSA over post-treatment nadir.
* Male aged greater than or equal to 18 years.
* Able to understand and provide signed written informed consent.

Exclusion Criteria:

* Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway within the past 3 months. Patients with a rising PSA level while on ADT for greater than 6 months are eligible.
* Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.
* Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET scan) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
* Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.
* Patients who are administered any high-energy (greater than 300 keV) gamma-emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\&T administration.
* Patients with known hypersensitivity to the active substance or any of the excipients of the IP.
* Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.
Couples Coping With Multiple Chronic Medical Conditions

Handling of complex health situations (as defined by multimorbidity) in partnership: communication between romantic partners; subjective illness perception; coping with stressful experiences due to multimorbidity.

Intervention : Expressive Writing about subjective illness perception vs. Writing about individual Time-Management Primary Endpoint: subjective Health (e.g. SF 12 questionnaire) Secondary Endpoints: Psychosocial Adjustments (Depression, somatic symptoms, quality of partnership and others)

Coping in complex health situations (as defined by multimorbidity) and the role of relationship processes for psycho-social adaption: The study investigates interpersonal emotion regulation, disclosure, and illness perceptions in couples with a multimorbid patient. The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing), the control condition are 3 sessions writing about individual time-management (placebo).

Primary endpoint: subjective health (SF 12 questionnaire) Secondary endpoint: psychosocial adjustments (depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality)

Eligibility Criteria:
Inclusion criteria:

* Age 18 or older
* multimorbid condition (two or more chronic medical conditions)
* patients living with romantic partner
* very good oral and written command in German
* written consent for participation by patient and partner

Exclusion criteria:

* Pregnancy
* Mini Mental State less than 26
* Substance Abuse
* Patients in Palliative Situation
* Patients isolated due to infectious diseases
* Patients participating in other clinical trials within the last 4 weeks before inclusion
The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

Patients with pulmonary arterial hypertension (PAH) have reduced health related quality of life (HRQOL) and impaired exercise capacity. Despite fourteen approved therapies, most patients die within ten years. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk distance (6MWD) and HRQOL improvement that often exceeds the effect of medications. Prior activity studies required inpatient rehabilitation, which is impractical, hard to sustain, and poorly scalable to a rare disease.

The Investigators propose a randomized trial of smart texts versus usual care for 6 months. The Investigators will randomize 100 PAH patients to the mHealth intervention or usual care. The Investigators will test the effect of a text-based mHealth intervention on HRQOL in PAH using the PAH-specific emPHasis-10 questionnaire. The Investigators will also test the effect of an mHealth intervention on exercise capacity, measured by a supervised home-based 6MWD test. Finally, the Investigators will examine the effect of the intervention on time to clinical worsening (composite of PAH therapy escalation, PAH hospitalization, and death) one year after randomization.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 or older.
* Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple congenital heart disease (i.e. atrial septal defect).
* WHO functional class I-III
* Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
* Forced vital capacity \>65% predicted with no or minimal interstitial lung disease based on reviews of imaging studies by PI and medical monitor.

Exclusion Criteria:

* Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity.
* Pregnancy
* Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
* Functional class IV heart failure
* Requirement of \> 2 diuretic adjustment in the prior three months.
* Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
Tolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease

Non-invasive mechanical ventilation (NIMV) is the recommended standard of care as initial therapy for patients with motor neuron disease (MND) with deterioration of the respiratory function.

SIGH_01 study is aimed at investigating the tolerability, safety profile and efficacy of sigh breaths during non-invasive mechanical ventilation in patients with MND in comparison to the standard ventilation support protocol.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent
* MND diagnosis according to El-Escorial criteria
* Non-invasive ventilation indications in accordance with the international guidelines

Exclusion Criteria:

* Inability to adhere to study visit schedule or lack of reliable caretaker
* Presence of dementia
* History of arrhythmia, heart failure or pneumothorax
"As Required" Oral Sildenafil in Raynaud's Phenomenon

The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* Active Raynaud's Phenomenon characterized by a clinical history of primary or secondary Raynaud's Phenomenon
* At least 7 RP attacks per week on 5 or more days per week (assessed over the 2 weeks preceding inclusion)
* Patients who have dated and signed the informed consent form
* Contraception for women

Exclusion Criteria:

* Recently diagnosed RP (less than 2 months).
* Uncontrolled hypertension, diabetes mellitus, angina
* Haemodynamic instability
* Nonarteritic ischemic optic neuropathy
* Pulmonary hypertension
* Subjects currently taking sildenafil, tadalafil or vardenafil
* Subjects currently taking nitrates
* Subjects currently taking strong CYP3A inhibitors
* Pregnancy (or considering pregnancy in the next 4 months)
* Breast feeding
* Participation in another clinical trial
Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses

This objective of this clinical study aims to confirm whether multiple kalifilcon A daily disposable toric contact lenses are providing the intended level of spherical aberration correction when worn.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.
3. A women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: she is currently pregnant, she plans to become pregnant during the study, she is breastfeeding.