cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression

Study hypothesis: Childbearing couples who receive the father inclusive psychoeducation program will have: (a) a lower level of depressive symptoms, (b) a higher level of marital relationship, and (c) a higher level of quality of life at 6 weeks, 6 months and one year postpartum than those who receive the usual perinatal care.

Background: Having a first child is a key marker of the transition into parenthood that requires substantial adjustment of couples' life. A recent meta-analysis published in the Journal of American Medical Association reports that both women (23.8%) and men (10.4%) suffer from perinatal depression \[1\]. The father's involvement during pregnancy can positively influence health outcomes not only for the man, but his partner, and their children \[1,2\]. However, the effectiveness of father's involvement in prenatal care in preventing paternal and maternal depression, is still unknown.

Aims: This study seeks to: (1) evaluate the effect of a father inclusive psychoeducation program for first-time Chinese mothers and fathers on depressive symptoms (primary outcome), marital relationships and quality of life at 6 weeks, 6 months and one year postpartum; and (2) explore fathers' involvement, their perceived benefits of participating in the program and factors influencing the effectiveness of the program.

Methods: This study employs a longitudinal, randomized, pre and post-test design. A convenience sample of 576 couples will be recruited at antenatal clinics and randomly assigned to one of three groups: (1) the experimental group with both couples receives the intervention on top of usual perinatal care; (2) the comparison group with only the women receives the intervention on top of usual perinatal care; and (3) the control group receives usual perinatal care only. The intervention consists of a single 3-hour session during pregnancy and two telephone follow-up at postpartum week one and week two. Primary outcome on postnatal depression will be assessed by Edinburgh Postnatal Depression Scale. Secondary outcomes on marital relationship and quality of life will be assessed by Dyadic Adjustment Scale and Medical Outcomes Study Short Form 12-item Health Survey, respectively, at baseline, 6 weeks, 6 months and one year postpartum. Process evaluation will be conducted at 6 weeks postpartum using individual telephone interview on 20 couples randomly selected from the experimental group.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 or above;
* first-time parents;
* able to speak and read the Chinese language; and
* Hong Kong residents.

Exclusion Criteria:

* couples with past or family psychiatric history
Self-regulated Constraint-induced Movement Therapy in Subacute Stroke Patients

Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT). This study aimed to examine the efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with subacute stroke. It was hypothesized that participants receiving the combined treatment (SR and CIMT) would have a better functional regain.

Background - Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT).

Objective - This study aimed to examine the efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with sub-acute stroke.

Methods - Seventy-six patients were randomly assigned to the self-regulated constraint-induced movement therapy (SR-CIMT; n=25), constraint-induced movement therapy (CIMT; n=27) or conventional functional rehabilitation (control; n=24) groups, and completed the trial.

The SR-CIMT intervention was two-week therapist-guided training using the SR strategy to reflect on the relearning of functional tasks with CIMT. Outcome measurements were for upper limb function (Action Research Arm Test, ARAT, Fugl-Meyer Assessment, FMA), daily task performance (Lawton Instrumental Activities of Daily Living Scale, Lawton IADL) and self-perceived functional ability (Motor Activity Log, MAL) at pre and post intervention intervals, and at one month follow up.

Eligibility Criteria:
Inclusion Criteria:

* sustained an ischemic type stroke with lesion in the primary or motor cortical areas resulting in hemiplegia,
* had stroke onset of less than 3 months,
* were aged above 60, and
* had 10 degree active extension in metacarpophalangeal joint and interphalangeal joint, 20 degree active extension of wrist joint

Exclusion Criteria:

* had excessive spasticity in the affected limb, as defined by a score of 2 or more on the Modified Ashworth Scale,
* had excessive pain in the affected limb, as defined by a score 4 or more using a Visual Analog Scale,
* had a score below 19 on the Mini-Mental Status Examination (MMSE), and
* had diagnosed of depression according to Diagnostic and Statistical Manual-IV (DSM-IV) criteria
Association Between Individual Clotting Factor Level Monitoring and the Risk of Bleeding Whilst Physical Active Conditions

The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically active

In patients with haemophilia (PwH) repetitive joint bleedings result in a so called haemophilic arthropathy, which is often associated with chronic pain as well as functional restrictions.

Due to the opportunity of sufficient factor treatment regimes, physical activity is no longer considered as a risk factor for PwH. In contrast, the large amount of current scientific evidence demonstrated high benefits of regular exercising for PwH. Meanwhile, physical activity is integrated as recommendation in the ´Guidelines for the management of hemophilia´. Nevertheless, the detailed influence of the exact course of the individual clotting factor level corresponding to the intensity of physical activities in consideration of possible bleeding events in adult PwH have not been examined to date.

The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically activie. Hereby the focus is on haemophilic specific parameters such as bleeding events, factor treatment and pain. On the basis of this study, an individualized clotting factor level should be determined which ensures a minimized risk of a bleeding event, considering type and intensity of the exercises. In line with these new findings, further interventional studies could be initiated in order to safely enhance the degraded physical performance as well as quality of life in PwH.

The generated knowledge could be further used in the development of haemophilic specific recommendations regarding physical activity in consideration of the individual clotting factor level.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from moderate or severe hemophilia A (FVIII \<5%, ≥ 12 years old)
* factor treatment with ADVATE© or ADYNOVI©
* use of myPKFiT

Exclusion Criteria:

* patients suffering from other coagulopathies
* participants without written consent
* participants \< 12 years old
* joint surgery like arthroscopy, synovectomy up to six months before study
* suffering from different rheumatologic diseases like M. Bechterew, Psoriasi or other local or generalized joint infections (Borreliosis, septic arthritis)
Evaluation of Post-PACU Pain Management in Pediatric Surgery

This study aims to assess the differences in overall pain severity, pain management, and satisfaction during recovery period between two groups of children who either receive or do not receive additional education related to expectation and management of postoperative pain.

With the increased frequency and popularity of pediatric ambulatory surgery, there is a greater need for evaluation of the postoperative pain experience after discharge from the hospital. Pain is one of the most significant factors affecting the postoperative experience in adults, and also be true in the pediatric population. Control of postoperative pain in children after discharge from the hospital poses particular challenges due to dependence on parental or caretaker ability to properly evaluate the child's pain, their understanding of appropriate dosing of pain medications, and their willingness to administer enough medications until sufficient relief is achieved.

The investigators aim to assess the differences in reported pain between groups who receive additional face-to-face education versus the current standard of care at a major US teaching hospital. The study will assess pain management after surgery using parental reports and questionnaires to assess their child's pain at multiple time points during the study. Additionally, this study will also assess baseline behavioral attributes of children and will compare behavioral changes at 24-48 hours, 7-10 days, and 2-4 weeks postoperatively as these behavior changes may also affect overall postoperative experience.

This study is divided into phase I and phase II. Phase I is the initial assessment of the investigators' institution's pain management in healthy pediatric patients undergoing ambulatory surgical procedures. Phase II consists of randomized trial which includes a randomized intervention group and control group. The group selected randomly for intervention will receive additional teaching regarding what to expect in terms of postoperative pain and how to properly identify pain in children.

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 1-6 years undergoing ambulatory surgical procedures.
* Patients with an ASA status of I or II spending 23 hours or less recovering in the PACU and discharged home.

Exclusion Criteria:

* Patients with an ASA status of III or IV.
* Patients admitted as inpatients or transferred to the PICU or inpatient for recovery, and any conditions that may affect pain expression or sensation.
Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant

This study is designed to evaluate clinical outcomes and spine fusion rates for patients undergoing transforaminal lumbar interbody fusion using the CONDUIT 3D printed titanium TLIF cage.

This prospective, single-center study is being conducted as a post market evaluation of the CONDUIT 3D printed titanium TLIF Cage. Patients undergoing transforaminal lumbar interbody fusions due to lumbar spinal pathology (i.e. central foraminal stenosis, degenerative disc disease, and/or lumbar spondylolisthesis) and have failed conservative care will be recruited for this study. Patients will be serially evaluated at 6 month intervals for a total of 24 months post index procedure to assess patient reported outcomes, clinical outcomes, and radiographic parameter, specifically spine fusion rates.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature adults ages 35 - 80 years of age, inclusive
* Diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral/bilateral foraminal stenosis
* Subject undergoing one or two level transforaminal lumbar interbody fusion
* Able to read and understand all documents used in this study , including the informed consent and patient-reported outcome questionnaires

Exclusion Criteria:

* Patients over 80 years of age
* Patients under 35 years of age
* Current smokers
* BMI\>42
* Subject has spondylolisthesis \> 2
* Subjects with multilevel \>2 levels of symptomatic disease
* Subjects with significant spinal deformity
* Subject is pregnant, plans to become pregnant or is breast feeding
Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial

this study has the aim to analize the correlation between three different methods of mesh fixation ( using absorbable or non absorbable sutures or fibrin biological glue) and recurrance and chronic pain ,in the Lichtenstein anterior inguinal erniorrhaphy

In the last decades the rate of recurrence in the anterior inguinal erniorraphy has been drastically lowered with the introduction of the mesh , on the other hand the rate of chronic pain is reported to be high in many papers.

The chronic pain influences the quality of life and what's more causes an increase in the social costs.

the classical Lichtenstein inguinal anterior erniorrhaphy , wich is the technique suggested by the international guidelines, expected to fix the mesh with non absorbable sutures .

The investigators would analyze the possible correlation between the method of mesh fixation and chronic pain keeping a lower rate of recurrence.

That said the primary endpoint in this study is the rate of recurrence and the secondary endpoint is the rate of chronic pain after lichtenstein anterior inguinal erniorrhaphy in the three different methods of fixation of the mesh

Eligibility Criteria:
Inclusion Criteria:

* primitive inguinal hernia
* age \> 18 years old
* compliancy to the study

Exclusion Criteria:

* reccurent inguinal hernia
* age \< 18 years old
* refusal of the study
A Study of How Long it Takes a Patient to Relapse After Switching From an Oral Antipsychotic to One of Two Doses of Long-acting Risperidone Injections in Patients With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.

Results from studies of older long-acting injectable antipsychotics (not risperidone) show that patients tend to relapse (which means start having symptoms again) when they are given low doses. However, increasing the dose may cause more side effects. This study will measure the time to relapse during a 52-week period in patients with schizophrenia or schizoaffective disorder who are switched from an oral antipsychotic (one taken by mouth) to one of two doses of long-acting risperidone injections (shots). The patients will be assigned to a dose of either 25 or 50 milligrams per injection every 2 weeks. Patients continue to take their usual oral antipsychotic medications up to 3 weeks following the first injection. After this 3-week period, they will receive the injectable risperidone only. Patients will be asked questions at each visit to help determine the effectiveness of the drug as assessed by the Clinical Global Impression Scale and the Positive and Negative Syndrome Scale. The safety of the drug will be based on patient signs and symptoms assessed according to the Extrapyramidal Symptom Rating Scale and self-reported treatment-emergent adverse events. Long-acting risperidone injection, 25 or 50 milligrams per injection, every 2 weeks for 52 weeks. Patients will continue to take their current oral antipsychotics for up to 3 weeks following the first injection of risperidone.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with schizophrenia or schizoaffective disorder
* stable with respect to disease symptoms and other medical conditions
* stable on any oral antipsychotic drug (except clozapine) for 4 weeks before the study
* patients identify a relative or acquaintance who can complete a questionnaire with additional information about the patient
* if female, using birth control.

Exclusion Criteria:

* Patient is not eligible if currently hospitalized, or was treated for an acute disease-related crisis within the past 4 weeks
* at risk to self or others
* use of injectable antipsychotic drugs or electroconvulsive therapy within past 6 months, or currently using carbamazepineor an oral antipsychotic drug in a dose that is higher than 8 milligrams per day in risperidone equivalents, of long-acting risperidone in an earlier study, of clozapine, or use of investigational drugs within 30 days, or of electroconvulsive therapy within past 6 months
* presence of liver or kidney damage
* history of neuroleptic malignant syndrome
* if pregnant or breast-feeding
* not using birth control
* abusing drugs or alcohol.
iPod Games in Hepatic Encephalopathy

To see if using ipod games can improve mental functioning


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis proven by biopsy, radiology or endoscopy
* Age 18-70
* Able to give informed consent
* Cognitive dysfunction defined by impaired performance on standard cognitive tests

Exclusion Criteria:

* Illicit drug or alcohol use within 3 months
* Trans-jugular intra-hepatic porto-systemic shunt (TIPS) placement
* Need for psychoactive medications apart from continuous anti-depressants or methadone
* Any focal neurological deficit or neuro-muscular disease
* Inability to function with an iPod
* Inability to understand English

For MRI: inability to perform brain MRI is an exclusion
Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement

Physical treatment with focused shock waves is effective in the treatment of tendonitis. Food supplements could facilitate the healing of tendinopathies when combined with shock wave therapy.

A single-blind, randomized prospective study (level of evidence IB) was designed. Patients with plantar fasciitis were recruited and randomized to group A and group B. Group A was treated with focused shock waves alone and group B with a combination of focused shock waves and tendon supplement. Pain remission (primary endpoint) and functional recovery (secondary endpoint) are monitored in both groups at three time points (Months 0, 3, and 6).

Eligibility Criteria:
Inclusion Criteria:

* plantar heel pain diagnosed clinically and instrumentally (ultrasound) as plantar fasciitis, that has not responded to conservative treatment for at least six months;

Exclusion Criteria:

* History of previous fractures or ankle and heel surgery;
* Recurrence of previous local painful episodes;
* Lesion of the plantar fascia on US examination;
* Presence of pathologies that affect the function of the foot (lumbar radiculopathy, Achilles tendinitis, Morton's neuroma, etc.);
* Chronic inflammatory conditions such as psoriasis, psoriatic arthritis, spondyloarthritis, ankylosing spondylitis, rheumatoid arthritis, chronic inflammatory bowel disease.
PK and PD of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients

A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases.

NTM are widely distributed in the environment and can especially be found in soil and water sources. These bacteria a very similar to tuberculosis bacteria. We are not that long aware that these bacteria can cause illness. Especially in patients with a chronic lung disease are sensitive to these bacteria and are susceptible to develop an infection. A lot of ambiguity consists about the best treatment of these infections. Up till now mainly the normal treatment for tuberculosis is used, however, the time period during which these medicines should be used and what dose should be used is mainly unknown.

To investigate whether the dose used at this moment is right a pharmacokinetic curve will be taken at steady-state.

Eligibility Criteria:
Inclusion Criteria:

* currently treated for NTM infection or recently diagnosed with NTM infection starting treatment at University Centre for Chronic Diseases Dekkerswald (Groesbeek), Centre for Revalidation Beatrixoord (Haren), or other outpatient clinics in The Netherlands.
* Diagnosis and treatment according to American Thoracic Society (ATS) criteria for NTM infections. Patients with pulmonary NTM infections (possible with extrapulmonary localizations as well) are eligible
* Treated with at least rifampicin and ethambutol and optionally with isoniazid, clarithromycin or azithromycin on a daily basis
* Age at least 18 years
* Patient has been using drugs for at least two weeks when steady state concentrations of the used drugs are expected
* Informed consent has been signed

Exclusion Criteria:

* The medical state of the patients does not allow inclusion according to the physician in attendance.
* The patients' clinical parameters urge immediate cessation of drugs.
* The patient is pregnant.
* Significant hepatic or renal dysfunction based on chemistry parameters (grade 1 according to an international adverse event grading system, see http:/ctep.cancer.gov) or symptomatic liver dysfunction (nausea and vomiting).
* Patients with cystic fibrosis, since these show deviating pharmacokinetics for many drugs.
* Patients with HIV infection, since these may show deviating pharmacokinetics for the drugs used in NTM disease.
PROACT - Pre-Operative Arimidex Compared To Tamoxifen

The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.


Eligibility Criteria:
Inclusion Criteria:

* Operable or potentially operable breast cancer
* Invasive breast cancer proven to be hormone-sensitive (ER+/PR+)
* Patients who might benefit from endocrine treatment prior to surgery
* Postmenopausal
* Signed written informed consent

Exclusion Criteria:

* Inoperable breast cancer
* Patient unwilling to undergo surgery
* Any reason why the patient may not be able to conform to study requirements
* Any previous treatment for breast cancer
* Previous Tamoxifen use as a part of breast cancer prevention trials
* Not willing to stop taking drugs that affect sex-hormones such as HRT
* Previous history of breast cancer
* Previous history of invasive malignancy within the last 10 years
* Any other severe disease that may prevent surgery, place the patient at risk, or influence the study results
* Treatment with an experimental drug within the last 3 months
* Risk of transmitting HIV, Hepatitis B or C