cyrilzakka/clinical-trials huggingface dataset:
The Jiaxing Birth Cohort in China

The Jiaxing Birth Cohort (JBC) is the largest prospective cohort study to explore prenatal risk factors, early life feeding practice and growth pattern/ adiposity in Chinese children.Between 1999 and 2013, 338 413 mother-child pairs were recruited in Jiaxing area in south-east China.Children of the recruited women were followed up at 1-2, 3, 6, 9 and 12 months of age, and subsequently followed up every 6 months to 36 months of age (toddler stage), and every year to 6-7 years of age before they went to school (pre-school stage). Follow-up rate was 70.8% at the toddler stage and 68.9% at the pre-school stage up to June 2013.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women came to clinic visit at one of the local hospitals during pregnancy at Jiaxing area
2. Pregnant women were followed up during pregnancy and their children were born alive at local hospital or clinics

Exclusion Criteria:

1. Those who did not want to participant
2. The infant was dead at the birth
3. Those pregnant mothers who dropped out during follow-up at pregnancy or moved out of the Jiaxing area
The AMOR Method: Resilience Training for Parents of Children With Autism

We will evaluate whether a resilience training program which includes group and individual parent training will be effective in improving optimism and resiliency in parents of young children with autism spectrum disorders (ASD). By observing the level of parent optimism and resiliency before and after intervention, we will be able to determine whether the intervention is effective in improving parent resilience.


Eligibility Criteria:
Inclusion Criteria:

Parents eligible to participate include parents: a) English-speaking, b) of a child aged 4:0 to 10:11 years, c) with a previous diagnosis of ASD and evidence of current social impairment (SRS-2) and repetitive behaviors (RBS-R), and d) who are able to consistently participate in sessions. Given budgetary constraints, direct diagnostic testing will not be feasible. Instead, child diagnostic status will be confirmed through review of the child's medical record for evidence that the child previously met ADOS criteria for ASD and shows clinically significant social impairment at baseline (SRS-2 T\>65).

Parents who are not eligible to participate include parents: a) with severe psychiatric, genetic, or medical disorder among parents and/or children, b) taking psychiatric medication, and c) with elevated resilience scores at baseline (Total Score \>80 on CD-RISC). The DSM-5 CCSM will be administered to parents to screen for parent mental illness. Any identified issues on the DSM-5 CCSM will be investigated further by the PI to rule out severe psychiatric disorders.

Exclusion Criteria:

a) Severe psychiatric, genetic, or medical disorder among parents and/or children, b) parents taking psychiatric medication, and c) parents with elevated resilience scores at baseline (Total Score\>80 on CD-RISC). The DSM-5 Cross Cutting Symptom Measure (DSM-5 CCSM) will be administered to parents to screen for parent mental illness. Any identified issues on the DSM-5 CCSM will be investigated further by the PI to rule out severe psychiatric disorders. These families will be referred for behavioral consultation (available in our clinic) and then be reconsidered for group participation.
Effects of Teriparatide Therapy for Japanese

In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

Several determinants were reported to be related to subsequent BMD increase, such as baseline bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive discussion is lacking. Specifically, there analyses were performed fragmentarily.

The main objective of this study is to reveal the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.

Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As a result, there is a lot of nursing home. But there are few reports concerning to the efficacy of teriparatide treatment in nursing home patients. The second objective is to reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes, bone turnover makers change, and adverse events.

Registry criteria: Patients treated in the investigators hospital using teriparatide. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (\< young adult mean 65%).

Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants

Eligibility Criteria:
Inclusion Criteria:

* severe osteoporotic patients

Exclusion Criteria:

* cancer, hypercalcemia, etc (i.e. patients who could not use teriparatide)
The Baltimore HEARS Pilot Study

The primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, accessible and effective hearing health care to low-income, minority older adults.

Age-related hearing impairment is strongly associated with poorer communicative functioning and social isolation, but hearing impairment often goes undiagnosed and untreated, particularly among minority and low-income older adults. Novel interventions that translate research on social engagement, minority health, and hearing technology are needed to expand delivery of hearing health care to underserved older adults. The Baltimore Hearing Equality through Accessible Research and Solutions (HEARS) project will develop and pilot a first-in-kind community-based intervention to provide affordable, accessible, and effective hearing health care to minority and low-income older adults and their communication partners. The study will follow a mixed-methods approach that will incorporate quantitative and qualitative components throughout the formative and evaluative processes. Participants and their communication partners will be randomized to an immediate treatment group or a 3-month delayed treatment group. The investigators hypothesize that the intervention is associated with increased social engagement and communication, improved quality of life, and decreased loneliness and third-party disability in the immediate treatment compared to the delayed treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* English-speaking
* Aural-oral verbal communication as primary communication modality
* Post-lingual hearing loss
* Does not currently use a hearing amplification device or hearing aid
* Signed informed consent to participate in baseline, 1 month, and 3 month assessments
* Have a communication partner able to accompany them to all study-related appointments

Exclusion Criteria:

* Individuals who do not fulfill inclusion criteria
* Score ≤ 25 on the Montreal Cognitive Assessment
Nitrite Mediated Cardioprotection During Coronary Artery Bypass Surgery

The purpose of this study is to determine whether sodium nitrite administration 24 hours prior to or during coronary artery bypass surgery protects the heart better from lack of blood flow which occurs as part of this type of operation. The study will also determine what the mechanisms of this cardioprotection are.

In recent years, there has been much interest in sodium nitrite as a cytoprotective agent in in vitro and animal models. A recent study undertaken in a canine model of myocardial infarction demonstrated a 50% reduction in myocardial injury following the administration of sodium nitrite prior to the ischemic event. In humans, the setting of coronary artery bypass surgery lends itself well to study potential cytoprotective agents. During cardiac surgery, the heart undergoes a period of ischemia allowing the surgeons to operate on the heart. This is followed by a period of reperfusion which in itself can add to cellular injury. Such injury can hinder post-operative myocardial recovery.

The aim of this pilot study is to determine whether the cardioprotective effects of sodium nitrite demonstrated in animal models are translated in humans and to determine the exact underlying mechanisms of this cytoprotection. Patients undergoing coronary artery bypass grafting surgery who give written, informed consent will receive sodium nitrite 24 hours prior to surgery, during cardiac surgery or placebo. Myocardial injury will be assessed through the measurement of biochemical markers such as troponin T. Cardiac biopsy samples will be obtained to determine underlying molecular mechanisms of this cardioprotection. The other aim of this pilot study is to determine what dose of sodium nitrite (i.e. 0.2mcg/kg/min or 1mcg/kg/min) is optimal for cardioprotection. This study will form pilot data also for a larger clinical trial with clinical endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective first time multi-vessel coronary artery bypass surgery
* Older than 18 years of age

Exclusion Criteria:

* Significant psychiatric /neurological impairment that might prevent adherence to the requirements of the protocol or the ability to give informed consent
* Inability to read the Information Sheet.
* Redo operation
* Age \>80 years
* Pregnancy
* Renal Impairment requiring pre-operative renal support
* Diabetes Mellitus
* Intended heart valve or additional surgery
* Episodes of angina or ischemia within 48hours prior to the procedure
Discomfort in Intensive Care Patients - IPREA-N

The purpose of this study is to investigate discomforts experienced by intensive care patients during their critical illness period. We will use the Norwegian version of the questionnaire Inconforts des Patients de REAnimation (IPREA), the IPREA-N.Patients will be asked to rate18 questions about different possible discomforts on a 0-10 scale after their intensive care stay. Furthermore we aim to test whether the questionnaire when translated into Norwegian is useful in the Norwegian patient population.

The aim of the study is

* to assess perceived discomfort in intensive care patients using the IPREA-N questionnaire
* to test psychometric properties of the questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Adult intensive care patients (\> 18 years),
* Understanding Norwegian
* Having spent more than 48 hours in the intensive care unit.
* Ability to consent to participation and self-report discomfort

Exclusion Criteria:

* Patients who move to another hospital and cannot complete the questionnaire within 24 hours due to health status or practical reasons.
Meaning-Centered Pain Coping Skills Training

This study is a randomized clinical trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and at least moderate pain will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 5- and 10-week follow-ups. The first aim of this study is to assess the feasibility of conducting a randomized clinical trial to test MCPC. The second aim is to characterize MCPC's effects on patient-reported outcomes of pain severity, pain interference, meaning in life, self-efficacy for pain management, and psychological distress. The third aim is to describe participants' experiences of MCPC using semi-structured qualitative interviews. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).

Many patients with advanced cancer describe pain as their most feared and distressing symptom. In this population, higher pain levels often predict worse physical, emotional, and existential/spiritual well-being. Psychosocial interventions show promise for improving cancer-related pain; however, no interventions address existential concerns (e.g., a loss of meaning in life) that are common among those facing pain from advanced illness. To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. MCPC seeks to teach patients cognitive and behavioral skills for managing pain (e.g., guided imagery) in order to help them engage with what gives their life a sense of meaning, purpose, and significance.

This pilot study is being conducted to prepare for a large-scale clinical trial that will test the efficacy of MCPC for improving patients' pain and pain-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Stage IV solid tumor cancer diagnosis; or stage III pancreatic or lung cancer diagnosis
* At least moderate pain (worst pain in past week \>/= 4 out of 10) at screening
* Eastern Cooperative Oncology Group (ECOG) performance status \</= 2 at screening
* Ability to speak and read English

Exclusion Criteria:

* Brain tumor diagnosis
* Significant cognitive impairment
* Untreated serious mental illness that would interfere with engagement in the interventions (e.g., schizophrenia)
* Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy
* Enrollment in hospice
Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114

To compare the efficacy of SMP-114 (120 and 240 mg/d) versus placebo in terms of the percentage of patients meeting the American College of Rheumatology criteria for 20% improvement in RA (ACR20) at week 24. The study hypothesis would be to demonstrate that the use of methotrexate and SMP-114 is more efficacious than Methotrexate alone.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged at least 18 years, with RA for a minimum of 6 months
* Has been receiving methotrexate treatment (stable for 8 weeks)
* Has active disease classified as ACR functional class of I, II or III

Exclusion Criteria:

* Has previously discontinued DMARD therapy due to hepatic intolerance
* Has received any DMARD in addition to methotrexate during the 4 weeks prior to randomisation
* Is receiving more than 2 DMARDs in addition to methotrexate at the time of screening
* Is receiving or has received Gold, leflunomide or biological agents including TNF/IL-1 inhibitors within the 8 weeks prior to randomisation
* Has previously failed 2 or more DMARDS
Analgesia and Pancreatic Cancer Surgery

Long-term survival for patients with pancreatic carcinoma is low, even following resection, the 5-year survival rate of patients ranges from 10 to 25%1. Most treatment failure is due to local recurrence, distant metastasis or both within one to two years after surgery2-4.

Surgery has been suggested to accelerate the development of preexisting micro metastases and to promote the establishment of new metastases5. Release of catecholamine and proinflammatory products secondary to surgical stress is believed to promote cancer progression6. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including numerous induction agents, volatile anesthetics and opioids, is associated with immunosuppression especially on the cell-mediated immunity which has a crucial role in prevention of micrometastasis5,7. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages to prevent perioperative cancer progression. Currently, most studies available in humans are retrospective and observational to evaluate regional anesthesia and prostate, colorectal, breast and cervical cancer-related outcomes8-12. Only one randomized study investigating major abdominal cancer surgery is available13. However, it is not specific to an individual cancer type and perioperative cell-mediated immunity is not evaluated.

In this study, we aimed to identify whether epidural block beneficial to early surgical and late cancer-related outcomes in patients receiving pancreatic cancer surgery. Perioperative cell-mediated immunity functions including natural killer cells, helper and cytotoxic T-lymphocytes were also investigated.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic cancer expected to receive curative Whipple operation

Exclusion Criteria:

* palliative operation
* preoperative chemotherapy or radiotherapy
* patients with metastasis
* contraindications for epidural catheter placement
* prior spine surgery
The Greek Version of Modified Baecke Questionnaire

The purpose of this study was to translate and investigate the validity and reliability of the modified Baecke Physical Activity Questionnaire (mBQ) in the Greek adult population.

The purpose of this study was to translate and investigate the validity and reliability of the modified Baecke Physical Activity Questionnaire (mBQ) in the Greek adult population. The cross-cultural adaptation of the mBQ was performed according to official guidelines.The reliability was determined by filling out the mBQ, two times, one week apart. For validation, the scores between the mBQ and the IPAQ were compared and the correlation between mBQ and VO2max and between mBQ and interview (METS) were assessed.

Eligibility Criteria:
Inclusion Criteria:

1. age above 18
2. Greek native speakers
3. Greek inhabitants
4. sufficient cognitive functioning.

Exclusion Criteria:

1. poor health status,
2. diagnosed with cardiovascular diseases
3. cardiac pacemaker,
4. medication that prevents exercise activity
5. neurological disorders with effect on the lower body
6. musculoskeletal disorders or injuries on the lower body in the last 3 months
7. PAR-Q health risk assessment form
Use of Local Infiltration Analgesia Following Total Hip Arthroplasty

The primary aim of this study is to evaluate if multiple postoperative administrations with a solution of ropivacaine, ketorolac and epinephrine into the operating field through a catheter would affect morphine consumption. Secondary end-points are pain intensity, side effects and length of stay.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total hip arthroplasty
* Patients \> 18 years of age
* Signed written informed consent
* Spinal anaesthesia

Exclusion Criteria:

* Allergy towards study drugs
* Rheumatoid arthritis
* Body Mass Index \> 35 (severe obesity)
* Pregnancy or nursing women
* Regular opioid use
* Patients who can not read or understand danish
Cortisol in the Treatment of Phobias

The aim of this prospective, double-blind, placebo-controlled, randomized study is to investigate if glucocorticoid treatment, in combination with exposure therapy, helps to reduce phobic fear in patients with phobia.


Eligibility Criteria:
Inclusion Criteria:

- Female and male patients with a specific phobia (fear of heights) according to DSM-IV criteria.

Exclusion Criteria:

* Severe acute or chronic somatic diseases
* Psychiatric disorder other than specific phobia
* Topic glucocorticoid therapy (for large skin parts)
* Inhaled glucocorticoids
* Psychotropic medication
* Pregnancy
Revealing Engagement Patterns Among Hepatic Encephalopathy Patients

This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in hepatic encephalopathy clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors.

In essence, this trial aims to deepen understanding of the factors influencing participation in hepatic encephalopathy clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition.


Eligibility Criteria:
Inclusion Criteria:

* Signed Written Informed Consent
* Aged ≥ 18 years old
* No prior treatment for hepatic encephalopathy

Exclusion Criteria:

* Participant is actively receiving study therapy in another
* Inability to provide written informed consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
Study of Tumor Infiltrating Lymphocytes Following CCRT in the Treatment of Patients With Cervical Carcinoma

A Phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma.

Concurrent chemoradiotherapy (CCRT) was the standard treatment for locoregionally advanced cervical cancer, while the incidence of treatment failure is still high. Adjuvant chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient survival compared to CCRT alone. Hence, there is a need for novel therapies to improve survival for these patients.

Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are effective for treating cervical cancer patients.

This is a phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervical uteri
* Patients with stage IIIA-IVA cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO)
* Patients who were ≥ 18 and ≤ 70 years old
* Patients with an ECOG performance status of 0, 1, or 2
* Adequate hematological, renal, and hepatic functions defined as:

granulocytes ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, total bilirubin, ALT and AST ≤ 1.5 x upper normal limit, creatinine ≤ upper normal limit

* Patients provided written, voluntary informed consent
* Patients who were accessible to follow up and management in the treatment center

Exclusion Criteria:

* Patients with past or current history of malignancy other than the entry diagnosis except for a "cured" malignancy more than five years prior to enrollment
* Patients who received previous chemotherapy or radiotherapy
* Patients with active angina or documented myocardial infarction within the 6 months preceding registration and patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure, as well as a history of 2nd or 3rd degree heart blocks
* Patients with an active infection or other serious underlying medical conditions that would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing platinum
* Patients with dementia or altered mental status that would prohibit the understanding and providing of informed consent
* Patients with inadequate caloric and/or fluid intake