cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Supplemental Calcium in Preventing Postpartum Depression

This study will evaluate the effectiveness of taking supplemental calcium while pregnant in reducing the risk of postpartum depression.

Postpartum depression is a combination of physical, emotional, and behavioral changes that occur after childbirth. The rapid drop in estrogen and progesterone levels, as well as the social and psychological changes resulting from the birth of a child, can often trigger depression in women. Common symptoms include crying, irritability, fatigue, loss of appetite, and feelings of guilt and anxiety. Women who develop postpartum depression often feel unable to care for their baby or themselves. Postpartum depression is common; it is estimated that about 10 percent of new mothers experience some symptoms of depression following delivery. Risk factors include a personal or family history of depression and a history of suffering from premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS). The purpose of this study is to evaluate the effectiveness of calcium supplements taken during pregnancy in reducing the likelihood of postpartum depression in women at risk for developing this condition.

Pregnant women who are at risk for developing postpartum depression will be enrolled in this study when they are between 16 to 26 weeks pregnant. All recruited women will undergo psychological testing for screening purposes. Women who are found to be depressed or suffering from other psychiatric disorders during screening will be referred to alternative treatment and will not be enrolled in this study. All participants will then be randomly assigned to receive either a calcium supplement (2 grams) or placebo on a daily basis. Treatments will continue throughout the remainder of each woman's pregnancy and for 12 weeks after she gives birth. Outcome measurements will include standardized questionnaires and psychiatric interviews to assess depression levels. If any participant exhibits significant depressive symptoms, she will be referred for psychiatric treatment. All measurements will be assessed at Weeks 26, 32 and 38 of the pregnancy, and 6 and 12 weeks after giving birth.

Eligibility Criteria:
Inclusion Criteria:

* Less than 26 weeks pregnant
* At risk for postpartum depression due to a family or personal history of depression or history of premenstrual dysphoric disorder (PMDD)

Exclusion Criteria:

* Currently depressed
* Currently taking medications for depression, bipolar disorder, or schizophrenia
* History of medication treatment for depression within 3 months of study entry
* Any of the following illnesses: diabetes, kidney disease, parathyroid disease, or untreated thyroid disease
* Currently taking a diuretic or calcium channel blocker
* Does not speak English
HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer

The purpose of this study is to look at the efficacy and safety of HR070803 in combination with 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to gemcitabine + capecitabine treatment as adjuvant therapy in patients with resected pancreatic cancer.

STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the disease-free survival. Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. Patients without event at the time of analysis will be censored at the date of last follow-up visit.

Secondary criteria include Overall survival. OS is defined as the time from date of randomization until the date of death from any cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit.

Secondary criteria also include 3-year disease-free survival rate/overall survival rate and 5-year disease-free survival rate/overall survival rate.

Tolerance Patients evaluable for toxicity must have received one investigational drug.

Eligibility Criteria:
Inclusion Criteria:

1. ECOG performance status 0 or 1
2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
3. Life expectancy of greater than or equal to 6 months.
4. Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
5. Acceptable hematology parameters and blood chemistry levels.
6. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
2. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
3. CA 19-9\> 180 U / ml within 21 days of registration on study.
4. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
5. Severe infection (\> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
6. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
Opioid-free Anesthesia in VATS Lung Resection

A comparison of incidences of postoperative opioid-related adverse effects and recovery parameters in patients undergoing video-assisted thoracoscopic surgery (VATS) lung resection receiving opioid or opioid-free general anesthesia (OFA).

Video-assisted thoracoscopic surgery (VATS) lung resection is traditionally performed under general anesthesia with opioid-based analgesia. It is associated with higher incidences of respiratory depression, hypotension, postoperative nausea and vomiting (PONV), dizziness, constipation and urinary retention, and more severe acute postoperative pain.

The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the primary outcome measures of the total incidence of opioid-related adverse effects (including respiratory depression, hypotension, PONV and dizziness) and secondary outcome measures of incidence of intraoperative and postoperative cardiovascular complications, pain relief, analgesic requirement , and other postoperative recovery parameters \[e.g. duration of tracheal extubation, departing from post-anaesthesia care unit (PACU), exhaust, defecation, and stay in hospital postoperatively\].

Eligibility Criteria:
Inclusion Criteria:

* Undergoing VATS lung resection.
* American Society of Anesthesiologists (ASA) physical status I-II.
* Agreed to participate in the trial.

Exclusion Criteria:

* Pregnant women
* ASA phase III or above.
* Undergoing emergency surgery.
* Planning for thoracotomy.
* Adults protected by law (under judicial protection, guardianship or supervision), people who deprived of their liberty.
* Patients who have received general anesthesia.
* Atrioventricular block, sinus node block or intraventricular block.
* Sinus bradycardia (heart rate is less than 60 beats/min).
* Preoperative hypotension (systolic blood pressure is less than 90mmHg)
* Combined with urolithiasis, Meniere syndrome, and vertebral artery stenosis
* Combined with cerebrovascular disease.
* Contraindication to NSAIDs drug.
* Allergic to anesthetics.
An Observational Study on Respiratory Complications After Gastrointestinal Endoscopy Assisted With Anesthesia

The purpose of this study is to investigate the incidence of respiratory complications after gastroenteroscopy, and establish a Logistic regression model to analyze the related risk factors of respiratory complications.

Gastrointestinal endoscopy is currently the most widely used and reliable technique for diagnosing digestive tract diseases.With the increasing need for pain relief and the improvement of anesthesiology technology, more and more patients prefer to undergo gastroenteroscopy under sedation or anesthesia.The painless technique of gastroenteroscopy is an anesthetic method , and like other anesthesia techniques, it brings risks as well as comfort.However, current studies mainly focus on respiratory and circulation-related adverse events during the examination , while little attention is paid to delayed respiratory complications after examination.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Qualified gastrointestinal tract preparation in strict accordance with the preparation requirements related to gastroenteroscopy;

Exclusion Criteria:

1. Patients with respiratory system symptoms or history before surgery;
2. Patients in need of a tracheal intubation;
3. Refuse follow-up;
Predictive Objective Parameters for Outcome of the Treatment of Stress Urinary Incontinence

To investigate the role of preoperative maximum urethral closure pressure and Valsalva leak point pressure in predicting outcome in patients who underwent trans-obturator tape for the treatment of female stress urinary incontinence.

A prospective observational descriptive study conducted from May 2002 to November 2005 at a single tertiary urban teaching University Uro-gynecological Department. 65 patients affected by stress or mixed urinary incontinence (stress component clinically predominant), defined according to International Continence Society guidelines, associated or not with urethral hypermobility underwent surgery which consisted of a fusion-welded, non-woven, non-knitted polypropylene tape (Obtape® Mentor-Porges). Preoperative MUCP and VLPP, stratified as ≤ or \> 40 cmH20 and ≤ or \> 60 cmH2O respectively, were separately or in combination correlated with primary (continence status: dry or wet) and secondary outcome variables (QoL questionnaires).

Eligibility Criteria:
Inclusion Criteria:

* Mixed urinary incontinence (stress component clinically predominant)

Exclusion Criteria:

* \> grade II uro-genital prolapse in any vaginal compartment
* Previous incontinence surgery
* Urine retention, neurogenic bladder, benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)
* Active pelvic inflammatory disease
* Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid)
* Pregnancy or lactation; AND
* Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range

This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo). The study will last for about 1 year. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years at the time of signing informed consent.
* Body mass index (BMI) of greater than or equal to 24 and less than 28 kilogram per square meter ( kg/m\^2) with the presence of at least one weight related complication (treated or untreated): Type 2 diabetes (T2D), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or BMI greater than or equal to 28 and less 30 kg/m\^2, with or without weight related complications at screening.
* History of at least one self-reported unsuccessful dietary effort to lose body weight.

For participants with T2D at screening:

- Diagnosed with T2D greater than or equal to 180 days prior to the day of screening

Treated with either:

* Diet and exercise alone or with 1-3 marketed oral antidiabetic drugs (metformin, alpha glucosidase, Sulfonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i) or glitazone as a single agent or in combination) according to local label.
* Treatment with oral anti-diabetic drugs should be stable (same drug(s) or active ingredient, dose, and dosing frequency) for at least 60 days before screening
* Glycated haemoglobin (HbA1c) of less than or equal to 10.0 percent (less than or equal to 86 millimoles per mol \[mmol/mol\]) as measured by the central laboratory at screening.

Exclusion Criteria:

* A self-reported change in body weight greater than 5 kilograms (kg) within 90 days before screening irrespective of medical records.
* Treatment with any medication for the indication of obesity within the past 90 days before screening.
* Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

For participants without T2D at screening:

- HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory.

For participants with T2D at screening:

* Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer

Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.

Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer.

This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.

This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old or \<75 years old
* ECOG 0-2
* biopsy proven adenocarcinoma of the pancreas
* no history of previous chemotherapy
* borderline resectable pancreas cancer
* no distant metastasis
* WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
* Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal
* Creatinine no greater than 1.5 times upper limit of normal
* informed consent

Exclusion Criteria:

* history of previous chemotherapy
* history of radiation at \>25% area of bone marrow
* stage unspecified, with distant metastasis, recurrent pancreas cancer
* history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). Patients who are NED after 5 years after treatment of malignant neoplasm can be candidate of this study
* pregnant, breast-feeding patient
* uncontrolled or active infection
* uncontrolled cardiopulmonary disease
Efficacy of Game-Based EMG-Biofeedback Therapy in Post-Stroke Dysphagia

This study aims to determine the effectiveness of game-based biofeedback application via surface electromyography in patients with post-stroke dysphagia. The same treatment interventions will be applied with and without biofeedback, and thus the contribution of adding biofeedback to the treatment will be determined.


Eligibility Criteria:
Inclusion Criteria:

1. History of hemorrhagic or ischemic stroke longer than 3 months
2. Being over the age of eighteen
3. Level ≤ 6 on the Functional Oral Intake Scale (FOIS)
4. Post-stroke onset of swallowing complaints
5. Ability to communicate with the patient and carry out the given commands
6. Mini mental test evaluation ≥ 24 points
7. Absence of concomitant serious systemic disease (unregulated hypertension, decompensated heart failure, malignancy, infection, pacemaker, epilepsy, etc.)
8. Detection of pathology in the oropharyngeal phase of swallowing in videofluoroscopic evaluation
9. Not taking any swallowing-related treatment in the last 3 months

Exclusion Criteria:

1. History of neoplastic disease and/or radiotherapy to the head and neck region
2. Having additional musculoskeletal disease or non-stroke neurologic disease that may cause swallowing disorders
3. Unable to communicate or carry out commands
4. Inability to maintain head-holding balance
5. Patients with severe pathology in bolus formation or delivery of the bolus to the pharynx during the oral swallowing phase
Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide

This study is designed to provide information on feasibility and reproducibility of barostat assessments of colorectal sensory functions and compliance and their pharmacological modulation


Eligibility Criteria:
Inclusion Criteria:

* A positive diagnosis of IBS.
* Subjects must either have been surgically sterilized, hysterectomized at least 6 months prior to screening, be postmenopausal or be using a double-barrier local
* contraception.
* Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent

Exclusion Criteria:

* History of or evidence for structural diseases/conditions that affect the gastrointestinal system.
* Other diseases or conditions that in the opinion of the Investigator significantly affect colorectal sensitivity.
* Evidence of occult blood at stool analysis, or history of rectal bleeding.
* Using or planning to use drugs or agents during the study period that alter GI physiology and visceral perception.
ePainQ - Feasibility Study

This is a feasibility study of a web-based pain self-management system aimed at providing support for acute postoperative pain and enhancing patient care. The ePainQ symptom questionnaire provides patients with immediate graded advice dependent on severity of issues reported. Information about self-managing these issues are provided via instructions in ePainQ with hyperlinks to more detailed advice on the ePainQ website. Patients log on daily postoperatively to complete the symptom questionnaire.

Women with invasive/non-invasive breast carcinoma due to be treated by surgery with curative intent will be approached to take part in this study. We will invite consecutive eligible patients, consenting as many willing patients as possible within a fixed 12 month recruitment period. There are 2 arms to the study: intervention -using ePainQ intervention \& standard care and a cohort (control) arm, which will be standard care only.

Primary aim: To test the feasibility of a web-based pain self-management system for breast cancer patients undergoing surgery Secondary aims: 1. a) Examine preliminary effectiveness of the system (impact on outcome measures, pain etc.) b) Explore the potential associations between breast density, post-surgical scarring and pain and outcomes 2. To explore staff use and perceived usefulness of ePainQ in clinical consultations.


Eligibility Criteria:
Inclusion Criteria:

Aged over 18 years of age at the time of diagnosis of cancer Primary operable (TNM categories: T1, T2, T3, N0, N1, M0; invasive breast cancer or non-invasive breast cancer (diagnosed on core biopsy or diagnostic incision biopsy) Ability to give informed consent Access to the internet (those without access to the internet may participate in the cohort arm) Ability to speak and write english

Exclusion Criteria:

* Male Disease unsuitable for surgery e.g. inoperable, locally recurrent or metastatic disease Previously treated invasive breast cancer There will be a restriction to people who are able to speak/read English. This is due to lack of funding for translation of study documents Pregnant women Patients without capacity to consent or those with a major psychiatric disorder No internet access (those without access to the internet may participate in the cohort arm)
Biological and Functional Markers for Precision Astronautical Biomedicine

In the current study the investigators will study early biomarkers of human degradation. In 10-day horizontal bed rest the investigators will enroll 10 healthy male subjects (18-30years, BMI 20-28kg/m2). Pre-, mid- and post-bed rest the investigators will perform various measurements, some of them will be invasive (blood samples and muscle biopsies), which will be carefully taken by the medical staff. The subjects will be placed in hospital rooms and have 24-hour medical supervision, adequate hygiene, nutrition, passive exercise, entertainment and visits.

Ten young male participants will undergo 10 days of horizontal bed rest. Before, during and after the investigators will monitor many biomechanical, metabolic, cardiovascular, biochemical responses.

During the bed rest period there will be no interventions. subjects will be allowed to rotate freely, with no vertical stimulus of any-kind.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 20 - 28 kg/m2
* male participants
* a healthy individual who is able to complete all the tests planned in the research protocol

Exclusion Criteria:

* smoking;
* regular alcohol consumption;
* ferromagnetic implants;
* history of deep vein thrombosis with D-dimer \> 500 μg·L-1;
* acute or chronic skeletal, neuromuscular, psychological, metabolic and cardiovascular disease conditions.