cyrilzakka/clinical-trials huggingface dataset:
Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms-3

The specific aims of this study are:

1. To develop a breathing training protocol specifically designed to improve HRV and psychosocial functioning for postmenopausal women with depressive symptoms,
2. To examine the immediate effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms,
3. To examine the intermediate-term effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms, and
4. To determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in HRV.

Postmenopausal women without hormone replacement therapy are associated with higher risk of cardiac morbidity and mortality. They are likely to experience depressive symptoms after menopause, and the comorbidity of depression are related to altered autonomic function. We expect that postmenopausal women with depressive symptoms who receive breathing training will demonstrate decreased depressive symptoms and increased heart rate variability immediately upon and later after completion of training, and optimally contributing to improve autonomic nervous regulation in their later life to prevent undesired cardiac outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Permanent termination of menstruation of natural cause.
* Cessation of menstrual cycles for more than 12 consecutive months.
* A score of the Chinese version of Beck Depression Inventory-II of greater than 10.
* Able to speak Mandarin or Taiwanese.
* Age from 45 to 64 years.

Exclusion Criteria:

* Subjects who are clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis, mental deficiency.
* Subjects who received hormone replacement therapy prescribed by gynecological physicians.
* Subjects who took cardiac and/or psychotropic medications which may affect the autonomic functions
The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III

To evaluate the effect of automated recording on frequency of recorded scores, number of automated notifications and serious events.

The frequency of EWS scores, number of automated notifications and serious events performed on a general ward is contingent on the quality and frequency of vital signs measurement like respiratory rate. This is due to the EWS escalation schemes of hospitals with an acute intervention team. Obtained sub-score trigger levels of vital signs contribute to higher and more frequent scoring.

We examine the influence of different respiration rate sensor concepts and measurements on scoring (NEWS and CREWS) and workflow in a typical UK gastroenterology and respiratory ward.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the study units during the period of data collection

Exclusion Criteria:

* palliative patients
Study of Intra- and Interpersonal Multimodal Synchronizations in a Social Interaction in Individuals with a Diagnosis of Schizophrenia.

The aim of this study is to precisely identify deficits in intra- and interpersonal multimodal synchronizations during social interaction in individuals with schizophrenia (ISZ). During a social interaction, individuals use both visual and auditory channels to construct their discourse. The auditory channel encompasses the semantics and prosody of the speech, while the visual channel describes the entirety of non-verbal gestures (e.g., facial expressions, body movements). Prosody and non-verbal gestures are essential elements for the speaker. By accompanying speech, they contribute to the planning and conceptualization of the utterance and enhance its communicative power. For the listener, prosody and non-verbal gestures are also used to provide sensory feedback to the speaker.

Several studies have shown the existence of intrapersonal and interpersonal synchronizations of prosody and non-verbal gestures during interaction. These synchronizations are associated with numerous social benefits (e.g., increased mutual appreciation and quality of interaction). However, certain mental disorders, such as schizophrenia, exhibit deficits in non-verbal behaviors that can impair these synchronizations and the associated social benefits. We hypothetized that interaction with individuals with a daignosis of schizophrenia will be associated with deficits in intra and interpersonal synchronization.

This study includes a pre-inclusion interview followed by a visit to the university hospital (CHU) lasting about 2 hours (including a break). During the visit, the patient participates in an experimental protocol consisting of two parts. In the first part, the patient will be paired with an interaction partner, and the two participants will engage in four distinct conversational tasks, including getting to know each other, free discussions, structured dialogues, and emotional interactions. In the second part, the participants will answer several questionnaires and perform neuropsychological tests in collaboration with an experimenter

Eligibility Criteria:
Individuals with a diagnosis of schizophrenia :

Inclusion Criteria:

* diagnosis of schizophrenia according to the DSM-V
* being able to read, speak and understand french
* giving eclaired consent

Exclusion Criteria:

* history of head trauma
* history of neurological conditions (epilespsy, multiple sclerosis, parkinson's disease, amyotrophic lateral sclerosis, huntington's disease, stroke)
* substance use
* pregnant women

Healthy controls :

Inclusion Criteria:

* being able to read, speak and understand french
* giving eclaired consent

Exclusion Criteria:

* diagnosis of psychosis
* history of head trauma
* history of neurological conditions (epilespsy, multiple sclerosis, parkinson's disease, amyotrophic lateral sclerosis, huntington's disease, stroke)
* substance use
* pregnant women
Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System

The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.

The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.

The study design is an interventional, prospective, single-arm, open label clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. The consent process has been completed with the subject, Legally Authorized Representative, or two physician best interest and consent is documented
2. Age \>18 years
3. Clinical signs consistent with an acute ischemic stroke
4. Baseline National Institutes of Health Stroke Scale (NIHSS) score \>= 6
5. Pre-stroke modified Rankin Score (mRS) \<= 2
6. Acute occlusion of the M1 segment of the middle cerebral artery (MCA), internal carotid artery (ICA), vertebral or basilar arteries confirmed via computed tomography angiography (CTA) and/or magnetic resonance angiography (MRA)
7. The Investigator estimates that at least one delivery of the Route 92 Medical Reperfusion System can be completed within 24 hours of time last known well
8. In the opinion of the Investigator, reperfusion of the ischemic territory will result in clinical benefit
9. Angiographic confirmation of an occlusion of the M1 segment\* of the middle cerebral artery, internal carotid artery, vertebral or basilar arteries with a modified Thrombolysis In Cerebral Infarction (mTICI) scale score of 0-1

Exclusion Criteria:

1. Known pregnancy or breast feeding
2. Known comorbidity that may complicate treatment or prevent improvement or follow-up
3. Known life expectancy \< 12 months
4. Known history of severe allergy to contrast medium
5. Subject known to have suffered a stroke in the past 90 days
6. Subject participating in another study involving an investigational device or drug.
7. Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, fibromuscular dysplasia, Ehlers-Danlos syndrome)
8. Any known pre-existing hemorrhagic or coagulation deficiency
9. Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage
10. Baseline CT or MRI showing intracranial tumor (except small meningioma)
11. Angiographic evidence of dissection in the extracranial or intracranial arteries
12. Angiographic evidence of carotid dissection
13. Angiographic evidence of multiple vascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation). Note: tandem occlusions may be included at the discretion of the operating physician.
HIPEC and Systemic Chemotherapy Combined With Apatinib in Unresectable Peritoneal Metastases From Gastric Cancer

The prognosis of patients with unresectable peritoneal metastases from gastric cancer is poor. These patients may obtain survival benefit from radical gastrectomy and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with gastric cancer. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy combined with Apatinib in the conversion therapy of peritoneal metastases from gastric cancer.

To determine the efficacy and safety of HIPEC and systemic chemotherapy combined with Apatinib in the conversion therapy of peritoneal metastases from gastric cancer, patients undergo HIPEC with Docetaxel/ Lobaplatin at the time of fist surgery and twice repeat within one week after the surgery, following 2 cycles of 3-week Oxaliplatin/S1 chemotherapy combined with Apatinib and 1 cycles of 3-week Oxaliplatin/S1 chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histological proved diagnosis of gastric cancer.
* Unresectable peritoneal metastases and primary tumor proved at surgery.
* No evidence of distant metastases.
* Have not received radiotherapy, chemotherapy or immunotherapy.
* ECOG score: 0\~2.
* Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

* Existence of distant metastasis outside the abdomen.
* Any previous radiotherapy, chemotherapy or immunotherapy.
* Active systemic infections.
* Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
* Female patients who are pregnant or breast feeding
Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

The purpose of this study is to evaluate the effect of zinc supplementation on insulin secretion by genotype of SLC30A8.

As diabetes increases at an alarming rate, strategies for prevention of this disease must be developed. For a given individual, there are both biologic (e.g., genetic) and environmental (e.g., lifestyle) factors that comprise her individual risk of diabetes. Researchers can take advantage the accumulating knowledge of these individual factors to design individualized strategies for diabetes risk assessment and prevention. For example, a mutation in a particular gene, SLC30A8, which encodes a zinc transporter, has been shown to increase the risk of diabetes probably through impairment of insulin secretion. In the proposed research project, the investigators aim to conduct a pilot study to see the effect of zinc supplementation on insulin secretion in people with and without this genetic mutation to see if zinc can improve insulin secretion in those with the mutation. The results from this study will help the investigators to plan a larger, more definitive study to determine if zinc supplementation can be used to prevent or treat diabetes in those with this mutation in SLC30A8.

Eligibility Criteria:
Inclusion Criteria:

* aged 21-70 years
* Amish decent
* genotyping of rs13266634 of SLC30A8 gene
* previously consented to contact for future studies and future use of DNA

Exclusion Criteria:

* Subject is a first-degree relative of another subject with the same SLC30A8 genotype
* diabetes mellitus (by history, treatment or random BG\>200 mg;dl)
* gastrointestinal disease causing nausea, vomiting, or diarrhea including inflammatory bowel disease by history.
* rheumatoid arthritis by history
* albumin \< 3.5 g/dL
* hemochromatosis by history
* hematocrit \<34%
* liver disease by history
* alanine aminotransferase or aspartate aminotransferase greater than 2.5 times normal
* renal failure by history
* estimated glomerular filtration rate \< 60 mL/min by MDRD equation
* use of thiazide diuretic and unwilling to discontinue if deemed safe in the opinion of the treating physician and study physician for 1 week prior to protocol initiation
* use of systemic corticosteroid and unwilling to discontinue if deemed safe in the opinion of the treating physician and study physician for 1 week prior to protocol initiation
* use of highly-active antiretroviral medications
* use of antipsychotic medications
* use of quinolone antibiotics
* use of tetracycline antibiotic and unwilling to discontinue if deemed safe in the opinion of the treating physician and study physician for 1 week prior to protocol initiation
* use of chelation therapy in the past month
* unwilling to withdraw from supplements for 1 week prior to the study and throughout study
* abnormal thyroid stimulating hormone (TSH) level
* serious disease precluding participation
* reported pregnancy or positive urine hCG test
* cancer diagnosis in past 2 years
* breastfeeding
* use of denture adhesive
Study on the Utilization of Cabozantinib in Adult Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) in 2nd Line Treatment Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy Under Real-real Life Clinical Setting in France.

The purpose of the protocol is to assess the Overall Survival (OS) at 1 year in patients after cabozantinib initiation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 age at the time of cabozantinib initiation
* Pathologically confirmed diagnosis of Renal Cell Carcinoma (Clear Cell or non-Clear Cell) cancer considered as advanced or metastatic at the time of cabozantinib initiation
* Intention to be treated with cabozantinib tablets according to the current local Summary of Product Characteristics (SmPC) (France)
* Initiating cabozantinib as a second line of treatment (Baseline visit must be performed before cabozantinib first intake)

Exclusion Criteria:

* He/she is already included in an interventional trial with an investigational product at the same time.
Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)

Multimodal treatment combining surgery with chemotherapy and/or radiotherapy is necessary to improve the chances of survival in patients with locally advanced thoracic esophageal cancer. However, there is no consensus about the neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma. The aim of current randomized controlled clinical trail is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiation therapy plus surgery on overall survival for patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal squamous cell carcinoma in 3 years. Eligible patients will be randomized into neoadjuvant chemotherapy group (paclitaxel 175mg/m2 plus cisplatin 75mg/m2, q21d, 2 cycles) or neoadjuvant chemoradiation group (41.4Gy, 1.8Gy\*23d plus paclitaxel 50mg/m2 plus carboplatin AUC=2, q1w, 5 cycles). The primary endpoint is 5 year overall survival and the secondary endpoints include 5 year disease-free survival, adverse events, pathologic complete response, postoperative complications, quality of life. The biomarkers predicting the sensitivity of neoadjuvant therapy will be explored.


Eligibility Criteria:
Inclusion Criteria:

* cT2-T4aN+M0 or cT3-4aN0M0 (8th TNM staging system) thoracic esophageal squamous cell carcinoma
* No metastatic cervical lymph node
* No anti-cancer treatment
* No contraindication for esophagectomy
* No contraindication for chemotherapy or chemoradiation therapy
* PS score 0-1
* Written consent is obtained

Exclusion Criteria:

* Previous cancer treatment history
* Concurrent cancer disease in other site
* Tumor length ≥8cm
* Tumor width ≥5cm
* Need continuous steroid treatment
* Cardiac infarction in 6 months
* Psychotic patient
* Can not achieve R0 resection
* Gastric tube can not be used for reconstruction after esophagectomy
* Pregnant woman
Twelve vs 24 Months of Dual Antiplatelet Therapy in Patients With Coronary Revascularization for In-stent Restenosis

Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding.

The ISR-DAPT Study is a multicenter, randomized controlled trial that will enroll 1000 subjects treated with percutaneous coronary intervention (PCI) for in-stent restenosis. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin after index procedure. All patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding at 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18-80 years of age
* Undergoing percutaneous intervention with stent deployment for the treatment of in-stent restenosis

Exclusion Criteria:

* Pregnant women
* Planned surgery necessitating discontinuation of antiplatelet therapy within the 24 months after enrollment
* Current medical condition with a life expectancy of \<2 years
* Concurrent enrollment in another device or drug study whose protocol specifically rules out concurrent enrollment
* Subjects on warfarin or similar anticoagulant therapy
* Subjects with hypersensitivity or allergies to one of the drugs
* Subjects unable to give informed consent
Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of OCD

This study aims to explore the efficacy and influencing of accelerated dTMS (deep Transcranial Magnetic Stimulation) treatment in patients with obsessive-compulsive disorder (OCD), and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).

The study is to recruit 86 eligible patients with obsessive-compulsive disorder (OCD) from the Shanghai Mental Health Center for deep transcranial magnetic stimulation (dTMS) intervention, and recruit 43 healthy controls who meet the enrollment criteria from the community. Among them, patients with OCD will be randomly divided into a real stimulation group and a sham stimulation group, with 43 cases in each group. After baseline assessment, dTMS treatment will be administered twice a day. EEG data collection, cognitive tasks, psychological self-assessment scales and clinical symptom assessment will be conducted before treatment，1 day after treatment and 2 weeks after treatment. MRI data will be conducted before treatment and 2 weeks after treatment. During the treatment process, patients will receive two treatments per day, each lasting 20 minutes, for a total of 2 weeks, or 28 treatments in total.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 50, both genders are welcome.
* DSM-5 criteria for OCD;
* Y-BOCS total score \> or = 16, despite treatment with an adequate trial of a serotonin reuptake inhibitor (SRI) and currently using adequate, stable dose of SRI at least 4 weeks. An adequate SRI trial is defined as treatment for at least 12 weeks on the SRI, that meets or exceeds the recommended dosage level for OCD;
* More than 9 years of education
* Right-handed

Exclusion Criteria:

* Any additional current psychiatric comorbidity, except for obsessive- compulsive personality disorder;
* Severe obsessive symptoms prevent the completion of necessary assessments;
* Has a history of receiving ECT therapy;
* Has received rTMS or tDCS treatment within the past two months;
* Has severe physical illnesses or any physical conditions that can induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, among others;
* Has a past history of neurological disorders (such as epilepsy, cerebrovascular accidents, etc.) or brain injuries, or a history of brain surgery;
* Has implanted medical devices such as intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, etc.;
* Serious suicide risk;
* Pregnancy or nursing of an infant;