cyrilzakka/clinical-trials huggingface dataset:
Training of Cross-cultural Competencies in Psychotherapists

The purpose of this study is to determine whether a web-based training program with text-based information as well as practical exercises can improve cross-cultural competencies in therapists.

As the number of patients from diverse cultures increases in psychotherapeutic care, cross-cultural competencies of therapists become increasingly important. In particular, mental health care of patients with immigration background needs to be improved as studies show that these patients drop out of treatment more often and benefit less from therapy. In addition, patients with immigration background and refugees show higher prevalences in mental illnesses. Nevertheless, evaluated training programs to improve cross-cultural competencies in psychotherapists are lacking. In particular, web-based training programs, which allow therapists to work time-flexible and at their own pace on a training, are, to date, missing completely.

For the current study, a web-based training program to improve therapists' cross-cultural competencies was developed. It is based on existing conceptions of cross-cultural competencies. The developed program consists of six modules with the following contents: definitions and conceptions of culture, the role of cross-cultural competencies in psychotherapy, the influence of prejudices and discrimination as well as the role of migration and acculturation, and culturally sensitive diagnostics. The modules contain PDF-files with text-based information, video files, case studies with associated questions as well as practical exercises. The main focus of the training is the participants' self-reflection concerning their conceptions of (their own) culture and their beliefs about culturally diverse patients. The training group will be compared to two other groups, i.e. an education only and a waitlist control group. Whereas the waitlist control group will not receive any training materials, the education only group will receive a slimmed down version of the training consisting only of text-based information files.

Eligibility Criteria:
Inclusion Criteria:

* current psychotherapeutic work
* Internet access
* sufficient German language skills
* ongoing or completed training in Psychotherapy

Exclusion Criteria:

* too much previous knowledge about cross-cultural competencies (\> 10h training)
Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）

The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty. The secondary objective is to compare the complication rates and neurological function recover following cranioplasty. Complication events after cranioplasty are investigated within 6 months after surgery and neurological function is evaluated at 3, 6 and 12 months after cranioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Skull defect with a diameter greater than 3cm
* No intracranial hemorrhage, intracranial hypertension or hydrocephalus (or treated) occurred more than 1 month after the previous operation
* Cranioplasty is feasible according to doctor's evaluation
* Patients must agree to participate in this clinical trial and the informed consent is signed by patients themselves or next of kin on behalf of the patient.

Exclusion Criteria:

* Manifestations of intracranial hypertension or untreated hydrocephalus
* Poor healing of skin wound
* Intracerebral infection or intracerebral hematoma is not cured
* Patients with operational contradictions, for example, poor general condition
Biomodulating Rotator Cuff Healing - A Proof of Concept Trial

Novel concepts in quantum biology of rotator cuff repair and author's novel findings on biomodulation inspired us to design a pragmatic non-pharmacological add-on rehabilitation protocol that may potentially decrease retear rates after arthroscopic repair using a knotted suturebridge technique. In this proof-of-concept trial, 146 patients will be randomized 1:1 to either a 6-weeks post-operative cryo-, photo- and electro-biomodulation protocol or a control group immobilized in a standard abduction sling for 6 weeks. Healing will be evaluated using the Sugaya classification on MRI at 1 year post-operatively.


Eligibility Criteria:
Inclusion criteria

* Patient is over 18 years old
* Patient presents with a symptomatic full-thickness tear as diagnosed preoperatively on ultrasound, arthro-CT or MRI.
* Absence of significant muscle atrophy or fatty infiltration of the affected tendon exceeding stage 2 of the Goutallier classification

Exclusion criteria

* Partial rotator cuff tear or other shoulder injury
* Planned concomitant procedures other than subacromial decompression, acromioclavicular joint resection or biceps tenodesis/tenotomy
* Irreparable rotator cuff tear
* Patients who present with cartilage lesions greater than stage II of the Outerbridge classification (≥15mm diameter) on preoperative x-ray
* Patient presenting with a known comorbidity that could affect the outcome of surgery (cervical radiculopathy, polyarthritis, neurological disease of the upper limb)
* Patient not able to give informed consent
The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers

A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers

A randomized, open-label, single dose, crossover clinical trial

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
* Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Systolic BP \> 140mmHG or Diastolic BP \> 90mmHg)
* AST or ALT \> X 2 UNL
* History of drug abuse or positive drug screening.
* Participation in other drug studies within 3 months prior to the drug administration.
* Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
Trial on the Effect of Media Multi-tasking on Attention to Food Cues and Cued Overeating

Childhood obesity is a critical public health problem in the United States. One factor known to contribute to childhood obesity is excess consumption. Importantly, excess consumption related to weight gain is not necessarily driven by hunger. For example, environmental food cues stimulate brain reward regions and lead to overeating even after a child has eaten to satiety. This type of cued eating is associated with increased attention to food cues; the amount of time a child spends looking at food cues (e.g., food advertisements) is associated with increased caloric intake. However, individual susceptibility to environmental food cues remains unknown. It is proposed that the prevalent practice of media multi-tasking-simultaneously attending to multiple electronic media sources-increases attention to peripheral food cues in the environment and thereby plays an important role in the development of obesity. It is hypothesized that multi-tasking teaches children to engage in constant task switching that makes them more responsive to peripheral cues, many of which are potentially harmful (such as those that promote overeating). The overarching hypothesis is that media multi-tasking alters the attentional networks of the brain that control attention to environmental cues. High media multi-tasking children are therefore particularly susceptible to food cues, thereby leading to increased cued eating. It is also predicted that attention modification training can provide a protective effect against detrimental attentional processing caused multi-tasking, by increasing the proficiency of the attention networks. These hypotheses will be tested by assessing the pathway between media-multitasking, attention to food cues, and cued eating. It will also be examined whether it is possible to intervene on this pathway by piloting an at-home attention modification training intervention designed to reduce attention to food cues. It is our belief that this research will lead to the development of low-cost, scalable tools that can train attention networks so that children are less influenced by peripheral food cues, a known cause of overeating. For example, having children practice attention modification intervention tasks regularly (which could be accomplished through user-friendly computer games or cell phone/tablet apps) might offset the negative attentional effects of media multi-tasking.

\[3/14/2020\]: Study recruitment temporarily halted due to the COVID-19 pandemic

Eligibility Criteria:
Inclusion Criteria:

* N/A.

Exclusion Criteria:

* Inadequate English proficiency, a vision disorder that is not corrected with corrective lenses, and relevant food allergies.
Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

Primary Objective:

To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).

Secondary Objectives:

* To assess effect of lixisenatide versus SU on:
* Changes in glycemic control;
* Changes in body weight.
* To assess overall safety of lixisenatide and SU.

The total study duration per patient will have a minimum 12 weeks and maximum 22 weeks (up to 2 weeks screening period + 8-12 weeks pre-Ramadan period + 29-30 days Ramadan + 0 4 weeks post-Ramadan period). This is a phase 3b study in Kingdom of Saudi Arabia and Bangladesh (instead of phase 4 for other countries).

Eligibility Criteria:
Inclusion criteria :

* Patients with type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin + SU (≤50% max allowed dose) ±1 oral antidiabetic (OAD) drug.
* Patients who express the intention to fast during Ramadan.
* Signed informed consent.

Exclusion criteria:

* At the time of screening age \< legal age of majority.
* Glycated hemoglobin (HbA1c) at screening visit: \<7.5% or \>10%.
* Body mass index (BMI) \<20kg/m\^2.
* Treatment with basal insulin for less than 6 months prior to screening.
* Prior antidiabetic medication (basal insulin and OADs) not at stable dose (eg, same medication, frequency and \<20% dose change) in the last 8 weeks prior to screening.
* Previous treatment with short or rapid acting insulin other than for short term use (≤10 days) in relation to hospitalization or an acute illness in the last 6 months prior to screening.
* Any discontinuation from a glucagon like peptide-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
* Patient not willing to perform self-monitored plasma glucose (SMPG) as required by protocol and to follow the instructions provided.
* Type 1, gestational or secondary diabetes.
* History of diabetic ketoacidosis.
* History of hypoglycemia unawareness.
* Any medical contraindication for sustained and safe fasting.
* Pregnant or breast-feeding women.
* Women of childbearing potential (WOCB) not protected by highly effective contraceptive method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
* Known hypersensitivity/intolerance to lixisenatide (Lyxumia) or any of its excipients.
* All contraindications of the comparator and protocol mandated background therapies or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Magnesium Balance of Citrate-based Continuous Venovenous Hemofiltration, Effect of Citrate Dose.

Rationale:

A higher citrate dose during continuous venovenous hemofiltration provides better anticoagulation but possibly a higher risk of citrate accumulation in case of metabolic limitations. A higher citrate dose also increases magnesium loss in ultrafiltrate, while a negative magnesium balance is unwanted.

Objective:

Aim of this study is to determine the magnesium balance of citrate-based continuous veno-venous hemofiltration (CVVH) and to determine whether and to which extent the magnesium balance depends on citrate dose.

Study design and methods:

A prospective randomized study conducted in critically ill patients with acute kidney injury (AKI), treated with CVVH, with either low dose citrate (2.5 mmol/L blood flow in the filter) or high dose citrate (4.5 mmol/L blood flow in the filter) as anti-coagulant, targeting a postfilter ionized Calcium (iCa) of resp. 1.3-1.6 mg/dL (0.325-0.4 mmol/L) and 0.8-1.1 mg/dL (0.2-0.275 mmol/L). Post-filter blood as well as effluent aliquots and bloodconcentrations in the patient are tested for the following variables:

(0 , 2 , 4, 6, 12 and 24 hrs): Total Magnesium (tMg) and total Calcium (tCa), ionized Ca (iCa)(bloodgas analyzer). In addition, hematocrit, albumin, total protein, ureum and creatinine and parathormone (PTH) are determined in arterial blood at 0 and 24 hrs or at the time of protocol exit and citrate concentrations in postfilter and arterial blood at 1 and 24 hrs or at protocol exit.

Sample sites: arterial line, postfilter port (after postdilution and calcium compensation), effluent sample. All flow rates to be noted.

Study population:

Twenty patients admitted to intensive care, requiring continuous renal replacement therapy (CRRT) for AKI.

Intervention:

Anti-coagulation with either low dose citraat (2.5 mmol/L blood flow) or high dose citraat (4.5 mmol/L blood flow) targeting postfilter iCa of resp. 1.3-1.6 and 0.8-1.1 mg/dL. Both regimens are within standard protocolled CVVH treatment in the intensive care department.


Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients requiring CRRT for AKI (RIFLE criteria)
* Written informed consent from the patient or legal representative

Exclusion Criteria:

* pre-existing chronic renal insufficiency requiring dialysis
* chronic immunosuppression
* liver cirrhosis Child-Pugh C
* severe or shock-related hepatitis
* Pregnancy
Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility

The investigators will investigate the effect of antioxidants and lifestyle factors on the level of oxidative stress. As oxidative stress cannot be directly measured, it will be approximated by the DNA fragmentation index (DFI) which reflects the level of DNA damage in sperm caused by oxidative stress.

This is a one-site prospective exploratory study at the University Clinic for Gynaecological Endocrinology and Reproductive Medicine in Bern. On total 78 men with male infertility will be recruited.

The primary objective of the study is to assess the effectiveness of 3 months of antioxidant-based therapy on changing patients' DFI level.

The objective of the study is to assess the effect of 3 months of antioxidant-based therapy on the level of DFI. We are primarily interested in testing whether the treatment effectiveness (i.e. the change in DFI level) depends on the initial level (i.e. before treatment) and treatment adherence.

The data will be collected by the physicians and added to the REDcap study registry. Access to the total data set is only permitted for the principal investigator.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate
* Written consent
* Men with infertility problems who want to start an infertility treatment with their partner

Exclusion Criteria:

* No measurement of DNA fragmentation possible
* Intake of prescribed medications
* Exposure to toxins
* Chronic diseases
Observational Prospective Study on Patients Treated With Norditropin®

This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Judged by the physician as per the Norditropin® label

Exclusion Criteria:

* Judged by the physician as per the Norditropin® label
Immediate Breast Reconstruction With Hybrid Fat Transfer

Investigators in this study describe a new perspective for female patients that will undergo skin-sparing mastectomy in which there will be an immediate reconstruction of the mastectomized breast for more satisfactory aesthetic results.

This study introduces a new perspective for women who will undergo mastectomy especially Goldilocks mastectomy in which the investigators do fat grafting to the medial and lateral pillars of the breast as well as the inferior dermal flap in order to have a voluminous remaining breast shape that is close enough in size with the contralateral breast for more aesthetic results and to observe the lipografted tissue reaction after radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Age 20 - 65 years old
* females with unilateral breast malignancy
* candidate for Goldilocks mastectomy procedure

Exclusion Criteria:

* Females with ages beyond the study frame.
* Females refusing to participate
* Fameles that not accepting the liposuction, lipofilling procedure
* Females with contralateral previously operated or mastectomized breast.
Rehabilitating Muscle After Intensive Care

The study will examine the effect of amino acid supplements and enhanced physiotherapy on physical recovery following critical illness in intensive care.

Critically ill patients aged 45 years and over will be recruited during recovery after intensive care. Using a randomised controlled, blind at follow-up design the study will examine whether the combination of an amino acid supplement and an enhanced physiotherapy programme improve the rehabilitation of muscle following intensive care better than a self-guided rehabilitation programme alone or with either an amino acid supplement or the enhanced physiotherapy programme. The Primary efficacy outcome will be the improvement in six minute walking test measured at 3 months post intensive care discharge. Secondary efficacy parameters will be insulin resistance, health related quality of life and muscle mass using DEXA scanning at 3 months and 1 year post intensive care discharge.

Eligibility Criteria:
Inclusion Criteria:

* 45 years of age and over with an intensive care stay of five days or more

Exclusion Criteria:

* Physically not capable of engaging with the practical requirements of the study
A Clinical Trial to Evaluate the Effects of a Herbal Tincture on Energy Levels, Weight Management, and Markers of Metabolic Health

This study will evaluate the effects of the Blue Burn Tincture on energy levels, weight management, and markers of metabolic health. It is a single-arm, hybrid trial involving 40 participants over a 12-week period. Participants will use the product daily, complete scheduled questionnaires, attend blood tests at Labcorp (Baseline and Week 12), and provide body mass measurements. Primary outcomes include changes in cortisol levels, energy levels, and body mass.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female.
* Be aged 30 or over.
* Anyone who owns a body weight scale.
* Anyone currently experiencing issues regarding all of the following:

  1. Self-reported feelings of stress.
  2. Self-reported issues with maintaining their current body weight or losing weight.
* Exercises at least once per week.
* If taking prescription medications, are willing to discuss this study with their physician before starting the study.
* Willing to maintain the study protocol for the study duration.
* Willing to refrain from taking any products, new medication, or supplements that target cortisol levels, stress, energy levels, or weight management during the study duration.
* If taking oral over-the-counter supplements or herbal remedies targeted at improving cortisol levels, stress, energy levels, or weight management, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration.
* Willing to maintain their current diet, sleep schedule, and activity level for the study duration.
* Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
* Resides in the United States.
* Not currently partaking in another research study and will not be partaking in any other research study for the next 12 weeks and at any point during this study's duration.

Exclusion Criteria:

* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Anyone who is planning to undergo any surgeries or invasive treatments for the study duration.
* Anyone diagnosed with a condition related to the thyroid.
* Anyone diagnosed with Type I or Type II diabetes.
* Anyone who has had any major illness in the last three months.
* Anyone who drinks heavily (i.e., eight or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
* Anyone with an allergy to nightshade vegetables.
* Anyone with known severe allergic reactions to any of the study product ingredients.
* Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
* Anyone with a history of substance abuse.
* Anyone who is currently a smoker or has been a smoker in the past 3 months.