cyrilzakka/clinical-trials huggingface dataset:
(Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients

Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. As this intervention can be offered in groups, costs are relatively low. In addition, delivering MBCT online might make the intervention more accessible and cost-effectiveness. However, more information is needed about what treatment works best for which patient.

Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both individual MBCT online and MBCT offered as a group training compared to TAU .

Study design: The design of the study will be a multi-centre, randomised, superiority trial, comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU condition will be randomised to one of the treatment conditions after 3 months. Main assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months after post-treatment (T3).

We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness skills, anxiety and depressive compants, psychological well-being, rumination and fear of cancer recurrence. We also expect the MBCT to result in patients returning to work earlier, have a higher work ability and have lower medical care costs, thereby being more cost-effective than TAU.


Eligibility Criteria:
Inclusion Criteria:

* HADS ≥ 11
* Cancer diagnosis (at present or past)
* Stable dose if using psychopharmacological medication for at least 3 months
* computer literacy and acces to internet
* capable of filling out questionnaires in Dutch

Exclusion Criteria:

* severe psychiatric morbidity as psychoses, suicidal ideation
* previous mindfulness-based treatment.
Management of Women With an Incomplete Miscarriage

Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, that is, before the fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated abdominal pain and cramping . The miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. If a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. However; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus.

From many years, the surgical curettage ('evacuation of the uterus') was considered the 'gold standard management' for miscarriage to remove the retained placental tissue. It is quickly performed and removed almost all the retained products of conception. However, the routine surgical evacuation of the uterus associated with higher rate of morbidity and mortality and should be limited for special indications.

Many studies compared the effectiveness of medical treatment compared to surgery in management of incomplete abortion. There is only one study compared the curettage with expectant management in those women after medical therapy.However; none of them, looked at the effectiveness of the second chance of medical treatment in management of incomplete abortion in trial to avoid the surgical intervention after failure of previous medical treatment. So we think that the immediate evacuation using surgical intervention is truly unnecessary in most cases of failed medical abortion and the patients may get benefit from another trial of medical treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Women with confirmed incomplete induced miscarriage, less than 12 weeks' gestation.
2. No known allergy to misoprostol.
3. Women who will be haemodynamically stable.
4. Good access to emergency facilities. Exclusion

1. Women with signs of severe infection ( fever \> 38°) 2. Women with severe vaginal bleeding 3. Women known to have allergy to prostaglandins 4. Severe abdominal pain requiring immediate intervention
Lifestyle Behavior Influences Among African American Patients With Stage 0-III Prostate Cancer Survivors and Their Partners

This trial studies the day-to-day stress, social support, and health lifestyle behaviors (such as physical activity and nutrition) in African American patients with stage 0-III prostate cancer survivors and their partners. How patients cope with stress may affect their lifestyle behaviors. This study may help understand not only survivors' behaviors but also partners' behaviors and how they interact.

PRIMARY OBJECTIVES:

I. Examine temporal associations between dyadic coping and health behaviors such as physical activity and diet.

II. Identify social and physical contexts in which health behaviors occur/co-occur among survivors and their partners.

EXPLORATORY OBJECTIVE:

I. Investigate potential moderators for the associations between stress and dyadic coping.

OUTLINE:

Patients and partners complete questionnaires over 60 minutes about demographic information, stress, coping, and lifestyle behaviors at baseline and end of study. Patients and partners also receive an accelerometer and complete Ecological Momentary Assessment (EMA) questionnaire on stress, coping, physical activity, and eating behaviors over 5-10 minutes four time daily (QID; 7:30 am, 11:30 am, 3:30 pm, and 7:30 pm) via an smartphone application (app) for 14 days. Patients and partners also complete a survey on nutrition twice weekly (BIW) for a total of 4 surveys.

Eligibility Criteria:
Inclusion Criteria:

* Survivors are eligible if they self-identify as African American adults
* Had stage 0-III prostate cancer (no restriction on time elapsed since diagnosis)
* Completed adjuvant therapy (i.e., chemo and/or radiation therapy)
* Live together with a current partner/spouse who is eligible for the study
* Do not need physical assistance (e.g., wheelchair, cane)
* Have a smartphone
* Can read and speak English
* Currently are not participating in a health behavior or weight management program
* Men on active surveillance will be included
* Partners are eligible if they are adults
* Partners are eligible if they do not have serious medical conditions (e.g., cancer, congestive heart failure, stroke, and dementia)
* Partners are eligible if they have a smartphone
* Partners are eligible if they can read and speak English
* Partners are eligible if they currently are not participating in a health behavior or weight management program
* The dyad can be either married or unmarried and same-sex or heterosexual

Exclusion Criteria:

* Survivors will be excluded if they had a prior history of other cancer or have metastatic cancer
Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years, with chronic genotype 1b HCV infection;
* HCV RNA level \> 10,000 and \< 10,000,000 IU/ml at Screening;
* Rapid response to triple DAAs therapy with less than 500 IU/ml plasma HCV RNA level at Day 2;
* No evidence of cirrhosis. Cirrhosis defined as any 1 of the following, within 6 months of study entry:

  1. Liver biopsy showing cirrhosis;
  2. Fibroscan showing cirrhosis or results\>12.5 kPa ;
  3. FibroTest® score \>0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) \>2 during screening.

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner;
* HIV or chronic hepatitis B virus (HBV) infection;
* Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
* Active or recent history (≤ 1 year) of drug or alcohol abuse;
* Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers);
* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often characterized by pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically impacting on women' quality of life. It is typically multifocal, involving uterosacral ligaments, the upper third of posterior vaginal wall, bowel, bladder, and ureters.

Indocyanine green (ICG) is an anionic tricarbocyanine molecule able to bind to plasma proteins into the vascular system and to become fluorescent if excited by near-infrared light (NIR). NIR-ICG imaging is used in gynecology for the intraoperative diagnosis of occult peritoneal and deep endometriosis at white light and to assess tissue perfusion and guide surgical strategy.

Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.

Ureter perfusion will be intraoperatively assessed using indocyanine green angiography.

After surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing laparoscopic surgery for endometriosis
* informed consent to participate in the study

Exclusion Criteria:

* known or suspected allergy to iodide
* history of active pelvic infection
* presence of intra-abdominal or pelvic malignancy
* pelvic radiation therapy
* hyperthyroidism
* liver dysfunction
* serum creatinine \> 2.0 mg/dL
Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study)

The PRESS trial is a single-center, two-part, randomized cross-over pilot study in Copenhagen that will evaluate 1) the safety and performance of Mirasol-treated and untreated platelet products stored for 2-4 days and for 7-days in Platelet Additive Solution (PAS) and 2) the correlation between the TEG® parameters and platelet count increments after platelet transfusions in thrombocytopenic subjects.

1. To evaluate in thrombocytopenic subjects the efficacy and safety of platelets treated with Mirasol Pathogen Reduction Technology (PRT) in Platelet Additive Solution. The following safety and efficacy measures will be compared between Mirasol treated and untreated platelets stored for 2-4 days and stored for 7 days:

   * Thrombelastography (TEG®) parameters: reaction time R, alpha angle α and maximal amplitude (MA)
   * Platelet Count Increment and Corrected Count Increment
   * Time to next platelet transfusion
   * Incidence of transfusion related (serious) adverse events
   * Incidence and severity of bleedings
2. To evaluate the use of the TEG® parameters as a measure for platelet transfusion efficacy and to evaluate the correlation between the TEG® parameters and the platelet Corrected Count Increments after platelet transfusions in thrombocytopenic subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of age of 18 years or older.
* Have thrombocytopenia or expected to develop thrombocytopenia requiring at least 3 platelet transfusions.
* Woman of child bearing potential must have a negative serum or urine pregnancy test within 72 hours before randomization.
* Subjects must have signed and dated the Informed Consent Form before performing any protocol related procedure.

Exclusion Criteria:

* History of any hypersensitivity reaction to riboflavin or metabolites.
* History of refractoriness to platelet transfusions (defined as 2 successive CCI1hr\<5000) or presence of human leukocyte antigen (HLA) antibodies or positive lymphocytotoxicity or previously documented alloimmunization.
* Previous exposure to PRT-treated platelet concentrates.
* Active bleeding requiring one or more red cells concentrate transfusions (i.e. grade 3 or 4 bleeding according to the WHO bleeding assessment scale in Appendix 1).
* Exposure to an investigational product, within 30 days before randomization.
* Splenomegaly (presence of a palpable spleen whose border could be felt more than 4 cm below the costal margin) or splenectomy.
* History or diagnosis of Immune/Idiopathic Thrombocytopenic Purpura (ITP), Thrombotic Thrombocytopenia Purpura (TTP), or Haemolytic Uremic Syndrome (HUS).
* Use of prohibited medication (see section 5.5).
* Pregnant or lactating females.
* Any medical condition or treatment that would be expected to compromise the effectiveness of a platelet transfusion or that would interfere with an expected platelet count increment.
* Any other medical condition that would compromise the participation of the subject in the study.
Evaluation of the Motor Activity, Cardiopulmonary Performance Capacity and Quality of Life in Patients Born With a Congenital Abdominal Wall Defect

The two most common congenital abdominal wall defects (AWD) are gastroschisis and omphalocele. Prenatal detection is often possible and the defects are differentiated by the presence or absence of a sac around the eviscerated organs. A omphalocele occurs in 0.6-4.8 in 10,000 live births compared to 4.5 in 10,000 live births with gastroschisis. In the last years a rising incidence of gastroschisis has been shown worldwide.

Both forms of AWDs necessitate early surgical intervention, mostly in one or two stages, and support at an intensive care unit in the first days of life. Additionally, patients need parenteral feeding in the first weeks of life. The outcome depends on the size of the defect and on the associated malformations.

The literature about long-term outcome of these malformations is scarce. Some publications have reported long-term complications like redo-surgical procedures because of fascial gaps or umbilical or incisional hernias. Furthermore, stool irregularities, abdominal pain and several admission to the hospital due to ileus or sub-ileus have been described. Additionally, half of the patients are unsatisfied with the cosmetic result.

Some other studies have shown that children born with an AWD have the same quality of life (QoL) compared with the healthy community.

Nevertheless, patients with AWDs need a standardized, structured and multimodal long-time follow-up program to be able to detect any problems early and give advice to understand their illness in order to achieve the same QoL as healthy children.

Therefore, the aim of this dissertation will be:

* to prospectively assess the motor activity, cardiopulmonary performance capacity and QoL of patients treated with AWDs in our Department
* to suggest a new standardized follow-up protocol for patients born with an AWD


Eligibility Criteria:
Inclusion Criteria:

* All patients born with an abdominal wall defect

Exclusion Criteria:

* mental disease
Text-Messaging to Motivate Walking in Older African Americans

This study examined the impact of using a motivational mobile text messaging intervention to increase step count among older community-dwelling African Americans. Secondary aims were to study the effects of text messaging on self-reported leisure time exercise behavior.

Hypothesis:

Participants in the motivational mobile text messaging group will have an increase step count after 6-weeks.

Background: Older minority populations can benefit from increased physical activity, especially walking. Text messaging interventions have the potential to encourage positive changes in health behavior in these groups.

Purpose: To examine if a six week program of motivational text messaging increases physical activity (step count) among older African Americans in an urban setting.

Design: Randomized, controlled trial pilot study with assignment to motivational text messaging group or a control group.

Setting/Participants: Thirty-six African Americans aged 60 to 85.

Intervention: The intervention group received motivational text messages three times a day, three days a week, for six weeks. Both groups received pedometers and walking manuals to record step counts. Study was conducted and analyzed in 2011.

Main Outcome Measures: Primary outcome measure was step count. Secondary outcome measure was perceived activity levels assessed by the Leisure Time Exercise Questionnaire (LTEQ).

Results/Conclusion: In press - American Journal of Preventive Medicine (Jan 2013)

Eligibility Criteria:
Inclusion Criteria:

* African American community-dwelling adults aged 60 to 85 who were recruited from senior centers.
* had to be healthy (no restrictions and medical clearance to walk)
* had to have a mobile phone with text messaging capability

Exclusion Criteria:

* (a) any physical, psychological illness, or medical problems that restricted them from walking; (b) did not own a mobile phone with text messaging capability; or (c) were not willing or able to follow study procedures.
The Effect of Pulse Flours on Blood Glucose, Satiety and Food Intake

Pulse flours represent a fast-growing segment on the functional food market; however, their health effects are not well understood. The observational studies and acute trials have established the link between frequent consumption of cooked whole pulses (beans, peas, lentils and chickpeas) and healthier body weight and improved blood glucose control. However, it is not clear whether these effects still remain after the processing of pulses into flours. The investigators hypothesized that the baked food products formulated with lentil flour of the same particle size as all-purpose wheat flour may reduce postprandial glycaemia and elicit a stronger suppression of subjective appetite due to its higher content of protein and resistant carbohydrate compared to all-purpose wheat flour. The treatments will be formulated either with lentil flour or with all-purpose wheat flour of similar particle size or with their combination. The objective of the project is to test the effect of foods formulated with lentil flour and/or wheat flour on blood glucose, short-term food intake and subjective appetite.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young male and female adults (19-35 y) with body mass index (BMI) of 20.0-24.9kg/m2

Exclusion Criteria:

* Breakfast skippers
* Smokers (including e-cigarettes) / cannabis consumers
* Those with BMI \< 18.5 and \> 24.5 kg/m2
* People with chronic diseases
* People with impaired blood glucose control
* People taking medication that may affect central and peripheral mechanisms of food intake regulation, blood glucose control, cognitive performance and sedative medication.
* People with intellectual disabilities (excluded due to their inability to comprehend hedonic and visual analogue scales used in the study).
* People with food allergies or gastrointestinal disorders (e.g., IBS and others).
A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients

The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.


Eligibility Criteria:
Inclusion Criteria:

* Sign the ICF
* Age ≥ 12 years
* Persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month, with the ACQ-745 test (see Appendix C) ≤ 3.0
* Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
* Initial FEV1 of at least 40% of the predicted normal value
* Serum cortisol assessment within normal values.

Exclusion Criteria:

* Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
* Requirement of admission due to asthma within the 3 months prior to study beginning
* Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
* Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
* Recent (\< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
* Intolerance or allergy to any of the components of the drugs assessed in the study
* Pregnancy or lactation
* Chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions
The Effect of Person-Centered Care Applied to Patients With Dementia on Nutritional Status

The aim of this study is to examine the effect of person-centered care on nutritional status of patients with dementia.

In this study, we think that since the practices that reduce the eating difficulties of patients with dementia and prevent possible problems will be applied in a person-centered manner, a different perspective will be developed in this field and will affect the care of the patients more positively.

In line with the observations made and the patient\&#39;s wishes, Montessori application, landscaping, special equipment such as high-contrast colored crockery, flatware, and spill-free containers, positive communication, effectiveness Person-centered care interventions such as activities will be implemented and their effects on nutritional status will be evaluated (Pre-test - post-test).

test randomized control group experimental design). No intervention will be made to the control group, they will only be observed.

Eligibility Criteria:
Inclusion Criteria:

* Being over 65 years old,
* Being diagnosed with dementia
* Being able to step on the scale (no lower extremity loss)

Exclusion Criteria:

* Acute disease state (pneumonia),
* Patients with PEG,
* Patients with severe visual and hearing impairment,
* Mild dementia patients,
* Parkinson\&#39;s patients,
* Patients with head trauma
Effect of Acceptance and Commitment Therapy on Psychotic Severity

Our study aims to assess the efficacy of Acceptance and Commitment Therapy on psychotic severity among Inpatients with primary psychosis: A Randomized Controlled Trial.

Current study was an open label, two-arm, parallel, randomized controlled trial, evaluating the efficiency of Acceptance and Commitment Therapy (ACT) added to treatment as usual (TAU) as opposed to treatment as usual (TAU) alone on patients with schizophrenia. The study adheres to the rules for writing Clinical Trials: "The Consolidated Standards of Reporting Trials" (CONSORT) statement

Eligibility Criteria:
Inclusion criteria Participants' criteria of inclusion involved those patients who were

1. Current psychiatric hospitalization;
2. DSM-5 diagnosis of a primary psychotic disorder; (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder, brief psychotic disorder, and unspeciﬁed psychotic disorder, this diagnosis was confirmed by a psychiatrist
3. 18 years or older;
4. ability to talk, read and write in Arabic; and
5. willingness to participate in the study that was scheduled for seven weeks.

Exclusion criteria Patients were excluded if they

1. had a comorbid learning disability or organic brain disorder;
2. psychosis related to a general medical condition or substance-induced psychotic disorder;
3. were considered mentally unstable; or
4. unfit to participate in the study by their therapist, and/or had newly had (been receiving) psycho-education or somewhat designed psychosocial intervention.