cyrilzakka/clinical-trials huggingface dataset:
The Effects of Relational Letter Writing

The main objective of this research is to explore the relational letter writing technique as an intervention for improving couples' relational well-being. This is a two-arm superiority randomized clinical trial. Sixty-eight couples will be monitored before, during, and after the intervention. To observe the effect of the relational letter, scores of couples who are in the intervention arm and control arm will be compared (between groups) as well as pre-post scores (within-group). The content of the letter writing will be qualitatively analyzed to explore the reconstruction of their ethical values. Results from both methods will be integrated in order to get an in-depth perspective of the newly developed intervention. It is expected to increase the array of available techniques to help couples improve their individual and relational well-being.

Relational letter writing is a recently developed therapeutic tool within the framework of Narrative Therapy that consists of two interviews and a letter writing task, in which a meta-conversation between the relationship itself, the couple members, and the therapists is fostered. Although this specific therapeutic technique can be used within the therapy process, in this study, it is used as a brief stand-alone narrative intervention.

The main objective of this study is to investigate the efficacy of the innovative Relational letter writing technique as a brief intervention for couples with mild to moderate levels of conflict. Also, the investigators want to explore changes in couples' narratives after experiencing the letter-writing procedure, and whether this technique can lead to reconstructing the relationship ethics and to greater relational awareness and well-being. The following objectives will be observed in this study:

* To explore the effects of Relational letter writing practice on couples' relational well-being
* To assess changes in individual psychological well-being after the Relational letter writing intervention
* To observe whether this technique can lead to reconstructing the relationship ethics and to greater relational awareness, and its relationship with the outcome
* To observe whether there is a difference between successful and unsuccessful cases in terms of the content of the letters.

Eligibility Criteria:
Inclusion Criteria:

* Couples willing to participate in a relationship enhancing intervention
* Couples should have been living together at least for 12 months

Exclusion Criteria:

* Couples who are currently receiving any kind of psychotherapy
* Participants presenting severe psychological disorders (Psychosis, substance abuse, major depression)
* Presence of intimate partner violence or abuse
* Participants presenting cognitive impairment or disability impeding them from writing or answering written information
* High-conflicted couples as measured by the DAS (Scores below 70)
Efficacy Testing of Collagen Peptide Drink

To assess Collagen Peptide Drink on skin condition improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
* Constant drug use
* Participated cosmetic product human study in the past 3 months.
Expanding the Infant Achievements Intervention Through Community Partnerships

The goal of the research study is to increase teachers' implementation of evidence-based practices in Early Head Start classrooms through the delivery of a professional development (PD) training intervention. The main questions that the study aims to answer are:

1. Does teacher participation in a PD intervention improve the use of evidence-based practices from pre- to posttest?
2. To what extent is the PD intervention feasible to implement in an established child care program?
3. To what extent is the PD program acceptable to teachers?

Participants will attend PD workshops and participate in content-related job-embedded coaching sessions during the implementation of the study.

The primary objective of the research study is to increase teachers' implementation of evidence-based practices in Early Head Start classrooms through the delivery of a professional development (PD) training intervention. It is hypothesized that teachers' fidelity to developmentally-appropriate practices, assessed through classroom observation measures, will increase following their participation in a comprehensive PD training intervention. The secondary hypotheses are that (1) the PD intervention is feasible to implement in an established child care program, and (2) the PD program is acceptable to teachers. Teacher participants will attend PD workshops, co-developed with community partners, and engage in follow-up job-embedded coaching sessions occurring weekly in their classrooms.

Eligibility Criteria:
Inclusion Criteria:

* Participants must currently work in an early childhood classroom serving children between 8-36 months of age.
* Participants must work in the role of a teacher or teacher assistant in an Early Head Start location.
* Participants must be willing to participate in two 60-90-minute trainings/workshops.
* Participants must be willing to participate in eight follow-up job-embedded coaching sessions

Exclusion Criteria:

* Works in a childcare setting outside of the Baltimore metro area
* Non-English speaking
The Effects of Intragastric Administration of Nutrients on Executive Control in Healthy Subjects.

The previous research by one of our members in the research team (H. Miller) suggests a possible influence of oral nutrients intake of certain fat or carbohydrates (glucose, fructose) on executive control. On the other hand, another previous study from our group (L. Van Oudenhove) suggests a subliminal influence of intragastric administration of fatty acids on subjective and neural responses to negative emotion induction. The purpose of this study therefore is to examine the effect of intragastric administration of certain fatty acids and carbohydrates on executive control in healthy volunteers.

Therefore one group of healthy volunteers are invited to the study. The participants will be randomly administered one of the three fatty acid emulsions or placebo via a nasogastric tube in each of the visits. After the exposure period, participants will use a computer to perform there different tasks to measure executive control. During each study visit, regular measurements of emotion, physical sensations, as well as blood glucose will be assessed. Furthermore, an electrocardiogram will be continuously recorded for the calculation of vagal function.


Eligibility Criteria:
Inclusion Criteria:

* N = 26 These numbers are based on a power calculation for a repeated measures ANOVA with one within-subject factor using Gpower software version 3.1.7 (http://www.psycho.uni-duesseldorf.de/abteilungen/aap/gpower3), indicating that these sample sizes are needed to achieve 90% power to detect a medium-sized effect (f = 0.25).
* Men \& women
* Age: \>17 years
* 20 ≤ BMI ≤ 25
* Of good mental and physical health

Exclusion Criteria:

Participants with one or more of self-reported points below will be excluded:

1. History of, or current presence of:

   * Psychiatric disorders (e.g., anxiety disorders, somatization disorder, eating disorders, depression, substance-related disorders alcohol abuse or dependence etc.)
   * Abnormal eating behavior (including restraint and emotional eating)
   * Abdominal/thoracic surgery
   * Neurological, endocrine or digestive related disorders
   * Head trauma with loss of consciousness
   * Other serious medical conditions
   * Use of any drugs, including cannabis, during the past 6 months
2. Current presence of:

   * Pregnancy
   * Medication use that affects the function of the gastrointestinal tract and/or affects the nervous system, psychotropics or painkillers
   * A recent accident or surgery that has not fully recovered
3. Other

   * Smoking
   * Women not taking hormonal contraception
Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula

Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* a patient who has complex perianal fistula
* a patient who is negative in pregnancy test
* a patient who has submitted a written consent

Exclusion Criteria:

* a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs.
* a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
* a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
* a patient who has an autoimmune disease
* a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
* a patient who has sepsis or active tuberculosis
* a patient who is pregnant or breast feeding
* a patient who has inflammatory Bowel disease
* over 2cm in diameter of fistula
Avatrombopaq In Patients With Cirrhosis

Thrombocytopenia is a frequent issue in patients with cirrhosis undergoing various types of procedures (e.g. liver biopsy, endoscopy and minor surgical interventions). Thrombocytopenia \< 50\*10\^9/L increases the risk of perioperative and postoperative bleedning and might prevent patients with cirrhosis to undergo important procedures. Doptelet is a small molecular trombopoetin agonist, which results in proliferation and differentiation of megakaryocytes in the bone marrow resulting in increased levels of thrombocytes. It is given orally as a pill and is used to increase platelet count in patients with severe thrombocytopenia (\< 50\*10\^9/L) and cirrhosis and thus not to normalize platelet count. This study investigates the safety and efficacy of Doptelet in patients with cirrhosis and thrombocytopenia (\< 50\*10\^9/L) undergoing minor procedures like Transjugular Adjusted Liver Biopsy (TJALB) and gastroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Age: \>17 years and ≤80 years
* ASA I-III
* Patients who read, understood and signed informed consent.
* Patients with a diagnosis of cirrhosis
* Thrombocytopenia \<50\*109
* The patient is scheduled for one of the following procedures: Transjugular Adjusted Liver Biopsy (TJALB), gastroscopy or percutan paracentesis of ascites in the following month.

Exclusion Criteria:

* Patients who do not speak and understand Danish.
* Patients who cannot cooperate within the trial.
* Patients who did not sign an informed consent regardless of the cause.
* Active drug abuse - to the discretion of the investigator.
* Thrombocytes \>50\*10\^9
* Patients with hereditary trombolic diseases (e.g. Factor V Leiden, antithrombin deficiency, protein S and C deficiency, prothrombin G202110A mutation).
* INR \> 1,7
* Ongoing infection verified by blood culture, clinical examination, and acute phase reactants (e.g. CRP)
Testosterone Replacement in Metabolic Syndrome and Inflammation

Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to address the effects of TRT on insulin resistance, body composition and pro-inflammatory status in naïve patients with MetS and HG.

The features of Metabolic Syndrome (MetS) include abdominal obesity, atherogenic dyslipidemia, raised blood pressure, insulin resistance or glucose intolerance. These symptoms are also frequently found in hypogonadal men.

Adipose tissue and androgens in male obesity are reciprocally linked. Total and free testosterone (T) are decreased in proportion to the degree of body fatness while T regulates insulin sensitivity and body composition. As a consequence, hypoandrogenism carries an additional independent risk for cardiovascular and metabolic disorders. Men with type 2 diabetes mellitus (T2D) exhibit lowered T levels that are inversely correlated to HbA1c. In addition, abdominal adiposity causes an impairment of testicular steroidogenesis that is directly linked to circulating adipokines; enhanced cytokine release from macrophage-infiltrated adipose tissue is pivotal to the pathogenesis of insulin resistance and atherosclerosis. Both MetS and T2D share with hypogonadism such a proinflammatory state.

For this reason we performed a randomized controlled trial on the effects of TRT on insulin resistance and circulating inflammatory markers in a cohort of middle-aged men with mild hypogonadism and MetS at first diagnosis, that were not taking medications known to influence the investigated outcomes. We established strict criteria for enrollment and used a physiological replacing therapy.

Given that testosterone replacement therapy (TRT) determines a reduction of body fat mass paralleled by an increase in fat free mass (6), and that TRT exerts an anti-inflammatory role inhibiting interleukins (IL), in particular the IL-6 gene (14), it remains to be established whether these independent effects also reflect in an improvement in insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* patients with Metabolic Syndrome according to ATPIII
* patients with mild hypogonadism (both testosterone evaluations between 6 and 11 nmol/L)
* patients naïve to hypoglycemic therapies

Exclusion Criteria:

* patients on hypoglycemic medications
* patients with severe hypogonadism (\<5 nmol/L)
* patients with borderline T values hypogonadism (\>11 nmol/L)
* patients with contraindication to testosterone therapy: prostate cancer, PSA\>4 ng/ml, severe hepatic or renal insufficiency, Hb\>17, Htc\>52%, severe urinary retention
Long Term Efficacy and Safety of TMS Targeting Cerebellum to Treat DRE

This study aims to observe the long term efficacy and safety of cerebellar continuous θ burst stimulation (cTBS) for drug-resistant Epilepsy during enhanced and maintenance phase，in order to provide a new treatment for long-term control of drug-resistant epilepsy and improve the quality of life of those patients. A total of 100 patients with DRE will undergo cTBS treatment by precise navigation to bilateral cerebellar dentate nuclei. The frequency and clinical feature of seizures, scalp EEG，clinical score, MOCA，MMSE，and QOLIE-31 were ssessed at baseline, after 2 weeks of enhanced phase，8 weeks of consolidate phase, and 8 weeks of maintenance phase.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old，
2. Participants who are diagnosed as drug- resistant epilepsy,
3. Participants who has a history of DRE ≥2 years before enrollment，
4. Participants who has a seizure frequency of ≥2 seizures every month within 3 months before enrollment,
5. Participants and their families are aware of this study and sign informed consent.

Exclusion Criteria:

1. Participants who are in status epilepticus,
2. Participants who are complicated with serious infection, cerebrovascular disease, malignant tumor and other nervous system diseases, with serious dysfunction of heart, liver, kidney and other organs, and with psychiatric disorders,
3. Participants plan invasive therapy, such as operation,
4. Participants who are in pregnancy or lactating,
5. Patients cannot tolerate repeated transcranial magnetic stimulation, or have contraindications of repeated transcranial magnetic stimulation.
Tissue Acquisition for Molecular Diagnostics

Acquisition of fresh tumor and normal tissue samples are necessary for the preparation of cDNA libraries, microarray chips, and tissue specific probes, and proteomics development and validation. This protocol will allow acquisition of samples at the time of tissue sampling for surgery, diagnostic tests, or therapeutic phereses. These samples will be forwarded without patient identifiers, pathology reports, or other labels. Tissue pathology will be verified within the Laboratory of Pathology and samples used strictly for CGAP and Proteomic Initiative indications.

Acquisition of fresh tumor and normal tissue samples is necessary for the preparation of cDNA libraries, microarray chips, tissue specific probes, and proteomics development and validation. This protocol will allow acquisition of patient samples at the time of tissue sampling for surgery, diagnostic tests, or therapeutic phereses. These samples will be forwarded without patient identifiers, pathology reports, or other labels. Tissue pathology will be verified within the Laboratory of Pathology and samples used strictly for CGAP and Proteomic Initiative indications.

Eligibility Criteria:
INCLUSION CRITERIA:

All patients willing to sign the informed consent for whom tissue, blood or body fluids will be available are eligible.

Histopathologic diagnosis will be confirmed in the Laboratory of Pathology, National Cancer Institute and is not a criteria for inclusion.
Plyometric Work Together With the Use of Ballast Weight in Lower Limbs in the Improvement of Performance in Jumpers

Introduction. The high jump is a discipline that use the shortening-stretching cycle. Plyometric exersices emply an eccentric load followed by concentric contraction. Powerinstep is a tool training by means of weigthed weigth whose objective is improving performance in athletes.

Aim. Evaluate efficacy of plyometric training with Powerinstep® in lower limbs, in the performance improvement in professional height jumpers from 18 to 40 years old.

Study design. Non-randomized clinical trial, single bind, with follow-up period.

Methods. 20 athletes will be recruited, that will be randomized to the two study groups: experimental (they carry out a plyometric training programme with Powerinstep) and control (won't be made a intervention on the subjects included in this group). The intervention consists of 6 week, with 2 session for week of 15 minutes duration each. The dependent variables will be the height of the jump, the time of flight, the reaction speed and the impulse force, measures though a pressure platform (model T-PLATE), employing Countermovement Jump, Abalakov and Drop Jump tests. We will make a descriptive statistical analysis. The Shapiro-Wilk statistical test will be used to calculate normality. Trough t-student test of repeated measures and an ANOVA of repeated measures will be calculated the difference between distinct assessment (preintervention, postintervention and follow-up) and the effect intra and inter subject, respectively.

Expected results. We want to observe the changes in performance improvement in height jumpers.


Eligibility Criteria:
Inclusion Criteria:

* Height jumpers
* Age between 18 and 40 years
* Currently participate in the competitive field

Exclusion Criteria:

* Present medical diagnosis of musculoskeletal pathology
* Who have not had musculoskeletal injuries in the last month
* Not signed the informed consent document.
A Prospective Multicentre Clinical Study of Dynamic Monitoring of Plasma ctDNA Methylation Markers to Predict Recurrence of Colorectal Cancer After Complete Resection of Peritoneal Metastases

The goal of this clinical trial is to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis after R0/R1 resection. The main questions it aims to answer are:

Preoperative and postoperative plasma ctDNA methylation detection (ColonAiQ) was performed in patients with peritoneal metastasis from colorectal cancer who underwent R0/R1 resection. Clinical information of patients was collected to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis.

Participants will:

The patients were followed up according to the normal review procedure of the hospital and the NCCN guidelines until at least 24 months after surgery. The review content included CT/MRI imaging evaluation and blood CEA (every 3 months). Whole-blood samples were obtained for timely plasma separation and ctDNA extraction at 1 month after surgery (before the start of postoperative chemotherapy) and every 3 months through 24 months after surgery. One blood sample was obtained when tumor recurrence was first detected on imaging.

Detection of methylation in tissue and plasma samples

1. GutSeer methylation NGS was performed on peritoneal metastatic cancer tissues and paired normal peritoneal tissues.
2. ctDNA GutSeer methylation NGS was performed on plasma samples before surgery, 1 month after surgery, 24 months after surgery, and when tumor recurrence was first detected by imaging examination.
3. ctDNA methylation PCR (ColonAiQ) was performed on plasma samples before surgery, 1 month after surgery, every 3 months to 24 months after surgery, and when tumor recurrence was first detected by imaging examination.


Eligibility Criteria:
Inclusion Criteria:

-1. No gender limit, age greater than 18 years old; 2, ECOG score ≤1; 3. Life expectancy ≥2 years; 4. Colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma confirmed by histopathology; 5, preoperative PCI score ≤20, peritoneal tumor cytoreductive surgery (CRS), surgery to achieve R0/1 resection; 6. Be able to understand the situation of this study and sign the informed consent.

7. The primary colorectal cancer has undergone R0 resection, and there is no extraperitoneal metastasis (except ovary).

Exclusion Criteria:

* 1. Combined with primary malignant tumors of other organs (current or within the past 5 years) (excluding patients with skin basal cell carcinoma and cervical carcinoma in situ undergoing radical treatment); 2. Severe mental illness or drug abuse; 3, severe heart, lung, vascular disease can not tolerate surgery; 4. Pregnant or lactating women.