cyrilzakka/clinical-trials huggingface dataset:
A Family-Centered Intervention When a Parent is Cared for in Specialized Homecare

The overall purpose of this project is to evaluate a family-centered intervention (the Family Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. The aims of the intervention are to increase family communication, the families' awareness of the impending death and their knowledge about the cancer illness, and thereby reduce the family members' long-term psychological distress.

The death of a parent is one of the most traumatic events that can happen to a Child. In our previous research, we have found that a lack of medical knowledge, communication and awareness of impending death increased long-term psychological morbidity among bereaved family members. Unfortunately, very few clinical interventions in palliative care have been conducted in Sweden.There is therefore a need to develop and evaluate interventions that aim to decrease the risk for psychological morbidity in families affected loss.

The overall purpose of this project is to evaluate a family-centered intervention (the Family Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. The aims of the intervention are to increase family communication, the families' awareness of the impending death and their knowledge about the cancer illness, and thereby reduce the family members' long-term psychological distress.

This study is a family-based intervention study among families where a parent of young children is seriously ill. It involves an intervention group and a comparison group. The two groups will consist of families where the seriously ill parent has at least one child in the age range 6-19 years. Around thirty families will be recruited by two interventionists through two specialized homecare unit in Stockholm and this is expected to take about 18 months. Families in the comparison group (N=30) will be recruited by a research member at two other specialized homecare units in the Stockholm area.

The effect of the intervention will be measured by questionnaires to both parents and children. Questionnaire data collection will be conducted before the intervention is started (baseline, for both intervention and control group). After two months there will be a follow-up for both groups. The next follow-up for both groups will be performed one year after the baseline.

In order to examine the meaning of the intervention for all family members and the study-feasibility we are planning to conduct interviews after meeting 5. Interviews with the whole family respectively each family members will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* At least one Child in the family 6-19 years
* Speaking and understanding Swedish
* One parent with severe illness or dying

Exclusion Criteria:

* If the family is in need of interpreter
Effect of Mantra on Hypertensive Patients

Mantras are specialized energized sound or words, which are defined most important sound therapy in Vedic healing. Present study was undertaken to evaluate the immediate effect of specialized Mantra chant on cardiovascular parameters in high blood pressure patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed and stable hypertension
* on regular medication

Exclusion Criteria:

* Individuals diagnosed with another lung disease,
* Have psychiatric, musculoskeletal or cardiovascular diseases,
* Being smokers
* Being pregnant
Stress & Self-Control Costs

Self-control failures are a universal challenge for healthy and clinical populations. Recent work suggests these failures may arise from excessive cognitive costs associated with exercising self-control, yet the mechanisms underlying these costs are unknown. To address this, the investigators will use a validated decision-making task that measures how much individuals will pay (from a study endowment) to restrict access to tempting rewards that may lead to self-control failures. The investigators will examine these costs to identify their cognitive, neural and affective mechanisms. First, the investigators will identify the cognitive and computational mechanism that gives rise to self-control costs. Second, the investigators will characterize the neural correlates of self-control costs and identify neural mediators and connectivity patterns stemming from these costs. Finally, the investigators will examine how different classes of stressors (physical, social, or lifetime stress) shape the behavioral and neural representations of self-control costs.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age, able to speak, read, and write fluently in English
* be willing and able to follow study procedures and provide informed consent.
* Must additionally confirm they are on a diet to maintain/lose weight and are implementing/maintaining dietary changes.

Exclusion Criteria:

* History of or medication for neurologic or psychiatric disease
* High-blood pressure or heart condition
* Diabetes, food allergies, metabolic disorders or history of eating disorder
* Use of corticosteroids or beta-blockers
* Metallic implants or devices contraindicating magnetic resonance imaging.
* Pregnancy is considered an exclusion criteria due to all stress and scanning procedures, thus pregnant participants will not be permitted to participate in the study.
Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis

To evaluate if transcranial magnetic stimulation can be used as a biomarker in Amyotrophic Lateral sclerosis (ALS).

To measure the effect on motor threshold (MT) by transcranial magnetic stimulation (TMS) after a single dose of perampanel at two dose levels.

Eligibility Criteria:
Inclusion Criteria:

1. A probable laboratory supported, probable or definitive ALS diagnosis by revised El Escorial criteria.
2. Sporadic or familial ALS.
3. Ages of 18-70.
4. Agree to use reliable contraception
5. Randomization will occur after a baseline MT has been established; any subject in whom a MT cannot be established will be excluded.
6. Caregiver willing to report adverse behavioral events. -

Exclusion Criteria:

1. History of epilepsy.
2. Significant laboratory abnormality (AST or alanine aminotransferase \>3x upper limit of normal, or glomerular filtration rate \<60)
3. History of aggressive behavior.
4. Subject unwilling to abstain from alcohol for 2 weeks after each dosing.
5. History of drug abuse in the last 5 years
6. Other severe medical conditions, including psychiatric conditions, which would cause an increased risk in the opinion of the investigator, including but not limited to renal failure and liver failure.
7. Skull defect or other physical contraindication for TMS
8. Pacemaker or implanted defibrillator
9. Inability to take study capsule by mouth

Females only: Subject is pregnant \[as confirmed by a positive serum human chorionic gonadotropin (hCG) test for females of reproductive potential (FRP) only\], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow use of reliable contraception.

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Evaluation of a New Enteral Feeding Tube for the Measurement of Esophageal and Gastric Pressure

Investigators aim to evaluate the accuracy in the measurement of the esophageal and gastric pressure of a new enteral feeding tube


Eligibility Criteria:
Inclusion Criteria:

* Requiring the placement of an enteral feeding tube

Exclusion Criteria:

* esophageal ulcers
* severe coagulophaty
* thrombocytopenia
Recasting or Book Reading by Parents or Clinicians

Developmental Language Disorder (DLD) affects approximately seven percent of the population and is characterized by grammatical deficits that cascade into lifelong academic challenges and under-employment. Current treatments for DLD produce good outcomes under ideal, high intensity conditions or when parents have been trained to deliver therapy using intense coaching methods; however, current publicly funded service delivery systems and private-pay reimbursement models do not support treatment being delivered in this ideal fashion for children older than three. This project will examine alternative methods of delivering treatment that may be more feasible under typical conditions and will identify implementation barriers, with the goal of improving long-term outcomes for children with DLD. We hypothesize that feasibility and palatability will influence dose, which will in turn affect the overall language outcomes.


Eligibility Criteria:
Inclusion Criteria:

Child with DLD

* Age: 4-9 years old
* Primarily English speaking: as documented by 20% or less exposure to another language, per parent report on the MAPLE
* Diagnosed with DLD as documented by standard score below 85 on the Diagnostic Evaluation of Language Variation - Norm Referenced (DELV-NR) composite, a dialect neutral assessment (Seymour, Roeper, de Villiers, \& De Villiers, 2005).
* Nonverbal Intelligence Quotient (IQ) within typical range as documented by a t-score at or above 35 on the Developmental Abilities Scale (DAS), matrices similarities subscale, (Elliott, 2007).
* Hearing within the typical range: Pass screening at 25 dB for 1, 2, 4 kHz; OR scores within the typical range via SoundScouts hearing screening app; OR clear hearing assessment from an audiologist, otolaryngologist, medical doctor, or other professional.
* No diagnosis of Autism: Cutoff score of 15 on the Social Communication Questionnaire, (Rutter, Bailey, \& Lord, 2003)
* No diagnosis of significant sensory-motor concerns or significant psychiatric disorders per parent report
* Able to benefit from treatment:

  * Score below 60% correct on experimenter developed elicited production probes of passives and object relative clauses
  * Producing simple transitive sentences (SVO) and mean length of utterance (MLU) of 2.5 on 100 utterance language sample

Caregiver

* Serves as the primary caregiver for an eligible child (may include grandparents, etc.)
* Basic literacy skills per self-report
* Willing to participate in caregiver training and caregiver-based treatments if child is assigned to that condition
* Willing to participate in questionnaires and structured interviews during post-test
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
* Presence of measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.
* Resolution of treatment-related toxicities.
* Adequate hepatic, renal, cardiac, and hematologic function.
* Additional cohort-specific criteria may apply.

Exclusion Criteria:

* Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
* Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
* Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
* Has received prior approved radiotherapy within 14 days of study therapy.
* Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Has an active infection requiring systemic therapy.
* Has known active CNS metastases and/or carcinomatous meningitis.
* Women who are pregnant or breastfeeding.
Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL

Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells.

This phase II trial is studying how well giving bortezomib together with rituximab works as first-line therapy in treating patients with low-grade B-cell non-Hodgkin's lymphoma.

This is a multicenter, prospective study.

* Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Treatment repeats every 35 days for 3 courses. Patients achieving a complete response, partial response, or stable disease proceed to maintenance therapy.
* Maintenance therapy: Beginning 6-8 weeks after induction therapy, patients receive bortezomib IV over 3-5 seconds and rituximab IV on day 1. Treatment repeats every 60 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected at baseline and periodically during study treatment.

After completion of study therapy, patients are followed every 3 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma
* Life expectancy \> 12 months

Exclusion Criteria:

* No known history of HIV infection
* No other active infection
* No peripheral neuropathy ≥ grade 2 within the past 14 days
* No uncontrolled hypertension
* None of the following cardiac conditions:

  * Myocardial infarction within the past 6 months
  * No heart failure
  * Uncontrolled angina
  * Severe uncontrolled ventricular arrhythmias
  * Electrocardiographic evidence of acute ischemia
  * Active conduction system abnormalities
* No serious medical or psychiatric illness that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior therapy for non-Hodgkins lymphoma
* No prior bortezomib or rituximab
* At least 3 weeks since prior chemotherapy, radiation therapy, immunotherapy, systemic anticancer biologic therapy, or anticancer hormonal therapy
* At least 2 weeks since prior investigational drugs
* No other concurrent systemic cytotoxic chemotherapy or investigational agents + No leukemia
The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask

Postoperative sore throat (POST) is an important problem after general anaesthesia. We assessed whether chewing gum preoperatively can reduce the incidence of POST after general anaesthesia administered via a streamlined liner of the pharyngeal airway (SLIPA).


Eligibility Criteria:
Inclusion Criteria:

American Society of Anaesthesiologists (ASA) class I or II 20-65 years body mass index (BMI) scores \<30 undergoing elective hysteroscopic surgery -

Exclusion Criteria:

chronic laryngitis chronic bronchitis asthma gastroesophageal reflux allergies to study drugs recent use of non-steroidal anti-inflammatory drugs (NSAIDs) a history of upper respiratory tract infection in the past one week Mallampati grade\>2 a history of steroid therapy.

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Clinical Effectiveness of Combining Mindfulness-Based Stress Reduction With Exercise Interventione

This study is to assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC).The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.

To assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC). A total of 60 lung cancer patients from a hospital in Shanxi Province were selected using convenience sampling and divided into an intervention group and a control group, with 30 patients in each group. The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. The two group were evaluated by the questionnaire three times. One day before the intervention, the first questionnaire was conducted, and the basic data of the two groups of patients were collected. The second questionnaire evaluation of anxiety, depression, sleep quality, and the Brief Symptom Rating Scale (BSRS-5) was conducted 6 weeks after the end of the intervention, and the third questionnaire evaluation was conducted 8 weeks after the end of the intervention to evaluate the intervention effect of the two groups. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with non-small cell lung cancer
* patients aged between 20 and 74 years, without gender limitation
* a score of 4-14 on the Short Symptom Rating Scale (BSRS-5)
* a clinical prognosis of at least 6 months
* clear consciousness, good functional ability, and unrestricted language communication
* written informed consent provided by the patient

Exclusion Criteria:

* patients with severe physical illnesses or symptoms that impede learning and are considered life-threatening
* patients with a BSRS-5 assessment score \> 15 and suicidal ideation \> 2
* patients unable to accurately describe their symptoms
* patients with limited cooperation ability
* patients who have previously undergone MBSR or other positive-thinking-focused psychotherapy methods
Comparison of Mini Gastric Bypass and Roux-en-Y Gastric Bypass

This study compares Roux-en-Y gastric bypass with single anastomosis gastric bypass in a randomized prospective setting. This study also adresses the issue of bile reflux after MGB.

Roux-en-Y gastric bypass (RYGB) and single anastomosis gastric bypass (SAGB or mini gastric bypass, MGB) have both shown excellent weight-loss and effect on comorbidities such as type 2 diabetes.

In this study eligible patients are randomized for either of the operations. Effects on glucose homeostasis as well as weight-loss and the effect on comorbidities are recorded during the follow-up.

Before the surgery and at 6 and 12 months, all participants will undergo body composition measurements (bioimpedance, MRI and DEXA), mixed meal tests and oral glucose tolerance tests, calorimetry and biopsies of skin, subcutaneous fat and muscle will be obtained and samples of urine, feces and saliva are collected. At these timepoints, all patients will fill out questionnaires regarding psychocological, social and physical health and wellbeing.

Interim analysies will be done for the first 60 patients (30 per group) after 3 months, in which safety issues and trial setup is reviewed. If there are no problems with safety and setup, the trial can be carried out according to initial plan.

At 12 months, all outcomes for all patients will be analyzed. Main outcome is weight-loss one year after the surgery.

Follow-up continues at 24months, 5 years and 10 years after the surgery and follow-up data will be analyzed accordingly.

Also, MGB has been feared to cause bile reflux. The first 30 MGB patients will undergo a gastroscopy and a hepatobiliary scintigraphy for bile reflux detection at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>35

Exclusion Criteria:

* Pregnancy
* Previous bariatric surgery
* Anemia
* esophagitis (LA B-D)
* esophageal intestinal metaplasia
Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant

This trial will investigate what surgical technique between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains is associated with the lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk pancreatic remnants.

Pancreatic fistula is the major determinant of outcome after pancreaticoduodenectomy. Several strategies to reduce the burden of this complication have been proposed in the last decade. A definite answer about what is the best technique to approach a high-risk pancreatic stump is still needed. Both pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains have been proposed in this setting, but often studies do not provide a reliable risk stratification and result are extremely variable.

The aim of this trial is to evaluate what surgical technique, between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains, is associated with the lowest rate of pancreatic fistula in case of high-risk pancreatic remnants. Risk stratification will be provided through the Fistula Risk Score, a clinical risk score that has been extensively validated.

Eligibility Criteria:
Inclusion Criteria:

* All the patients undergoing pancreaticoduodenectomy (only Whipple or Traverso) for all kind of pancreatic disease (benign, malignant or premalignant).
* Patients able to give their informed consent

Exclusion criteria

* Informed consent withdrawal
* Impossibility to undergo surgery for any reason
* Use of glues or biological matrices to protect the anastomosis
* Fistula Risk Score \< 7
* Post-operative octreotide analogues administration (only prophylactic use, therapeutic use allowed)
* Wrong randomization