cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Trial Comparing Intrathecal Morphine with Quadratus Lumborum Block for Post-cesarean Delivery Analgesia

Pain after caesarean delivery (CD) can interfere with the moms' ability to look after her baby and may contribute to developing long term pain and disability. Women having a CD receive pain medication (morphine) as part of their spinal anesthetic to help with pain relief after surgery. Morphine works well however has several side effects such as nausea, vomiting and itching which may be severe enough to make it difficult to care for herself and her new baby. In some cases, morphine causes difficulty in passing urine within first 24-hours of the CD requiring catheterization and thus restricting mobilization. The quadratus lumborum block (QLB) is a newer nerve block that uses local anaesthetic solution to numb the nerves carrying pain sensation from surgical incision site. QLB may be able to provide effective pain control without the side-effects associated with the spinal morphine. This study is to determine if women receiving QLB have as good pain control with fewer side effects than those who do receive the spinal morphine. Adequate pain control will be assessed by their pain scores and recovery in the 24 to 48 hours after CD. The side effect profile of the two techniques, quality of recovery and long term impact will also be compared during this study.

In addition, we would like to compare the patients who received both analgesic regimens (ITM and QLB) with patients who received only one analgesic intervention (i.e. either ITM or QLB). Further, the study will help us answer if combining the two analgesic interventions if beneficial or not.


Eligibility Criteria:
Inclusion Criteria:

* Non-emergent CD with planned spinal anesthesia
* American Society of Anesthesia physical status class I \& II;
* Age ≥18 years;
* Term gestational age (≥37 weeks);
* Singleton pregnancy;
* English-speaking.

Exclusion Criteria:

* Morbid Obesity (BMI ≥35 kg/m2);
* Subjects with significant obstetric or neonatal co-morbidities;
* Patient enrollment in another study involving medication within 30 days of CD;
* Any other condition, which may impair patients ability to co-operate with data collection;
* Patient height less than 152 cm (5'0");
* History of opioid tolerance or sensitivity;
* Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs);
* Women with a history of illicit drug use or prescribed opioids or benzodiazepines.
Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy

Electroconvulsive therapy (ECT) is an effective treatment for depression compared with the current antidepressant agents，but the most important side effect is cognitive dysfunction. The purpose of this study is to determine whether subanesthetic dose of ketamine combined with propofol is superior to propofol anesthesia alone in improving cognitive function in depressive patients undergoing ECT.

Depression is one of the most debilitating and widespread illnesses affecting up to 20% of individuals in their lifetime. However, the current antidepressant agents take weeks to work, and fail to help at least 40% of depressed patients. Electroconvulsive therapy (ECT) is a remarkably effective treatment for depression, but its use is limited by cognitive dysfunction.

As a result, it is becoming a clinical problem which need to be settled urgently. Previous clinical study showed that subanesthetic dose of ketamine could play a role in antidepressant effects with safety and minimal positive psychotic symptoms.The investigators also found that subanesthetic dose of ketamine combined with other anesthetics could improve cognitive function in depressive rats receiving electroconvulsive shock (a model for analogy with ECT). Few clinical researches concerned the effects of subanesthetic dose of ketamine combined with propofol anesthesia on cognitive function in patients after ECT, therefore the investigators conduct this randomized controlled double-blind trial. In this study, cognitive function will be rated by Mini-Mental State examination score.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with moderate or severe depression according to Diagnostic and Statistical Manual of Mental Disorders
2. aged from 18 to 65 years old

Exclusion Criteria:

1. cerebrovascular malformation, arterial aneurysm, hypertension, or glaucoma;
2. classification of American Society of Anesthesiologists physical status score IV or V;
3. complications such as respiratory disease, cardiovascular disease, intracranial hypertension, cerebral vascular disorder;
4. presence of a foreign body such as pacemaker, intracranial electrode, and clips;
5. history of seizures;
6. history of drug abuse;
7. concomitant presence of a mental disorder;
8. pregnancy;
9. history of serious adverse effects related to anesthetics;
10. refusal to consent for the study, or refusal to undergo one single ECT during the first week of therapy.
11. hyperthyreosis
Professional Breastfeeding Support Intervention

The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes.

The aim of this study is to determine whether early post-partum professional breastfeeding support improves breastfeeding outcomes.

The primary hypotheses are:

1. Exclusive breastfeeding rates at 1, 2, and 3 months will be increased among mother-infant pairs who receive professional lactation support or telephone follow-up support (intervention groups) when compared with those who receive usual post-natal breastfeeding support (control group);
2. The rate of any breastfeeding (predominant or partial) at 1, 2, and 3 months will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;

The secondary hypotheses are:

1. The overall duration of exclusive breastfeeding will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
2. The overall duration of any breastfeeding (predominant or partial) will be increased among mother-infant pairs in the intervention groups when compared with those in the control group.

Eligibility Criteria:
Inclusion Criteria:

1. delivers at participating trial site,
2. primiparous,
3. intends to breastfeed,
4. 18 years of age or older,
5. has singleton pregnancy,
6. Cantonese speaking,
7. Hong Kong resident for more than one year,
8. no serious medical or obstetrical complications

Exclusion Criteria:

1. \< 37 weeks gestation,
2. an Apgar score \< 8 at five minutes,
3. a birth weight \< 2500 grams,
4. born with any severe medical conditions or congenital malformations,
5. is placed in the special care nursery for more than 48 hours after delivery,
6. is placed in the intensive care nursery after delivery,
7. not entitled to health benefits in Hong Kong (NEP).
Collection of Samples From Patients With MDS

The purpose of this study is to collect information and bone marrow, blood, saliva, cheek cells and skin to be used in the laboratory to assist the sponsor in identifying a new way of treating MDS.

Goals of the study:

The purpose of this study is to collect the blood and marrow samples, and non-involved fibroblasts, that are required to identify the unique, personalized array of mutation-driven neoantigens that are expressed by the subject's MDS cells and to assess the feasibility of immunizing and expanding one or more of the patient's T cells ex vivo for investigation of their use as adoptive cellular immunotherapy.

Eligibility Criteria:
Patients must meet the following initial inclusion criteria:

* Diagnosis or suspected diagnosis of MDS or CCUS
* Age 18 or older

Patient exclusion criteria:

* Currently receiving or within 3 months has received hypomethylating agent(s), lenalidomide, cytotoxic agents, or within the previous 4 weeks corticosteroids \> 5 mg prednisone daily or any other immunosuppressants
* Previous allogenic transplant
* Inability to provide consent
* Prisoners
Effect of Nano-hydroxyapatite and LASER on Dentin Hypersensitivity

The aim of this study was to evaluate the effect of nanohydroxyapatite associated with low potency laser therapy in eliminating or reducing dentin hypersensitivity in a randomized placebo-controlled clinical trial. Volunteers 18 to 50 years old with hypersensitive teeth were randomized into 4 groups: GPLACEBO - positioning of the laser tip without light emission + placebo dentifrice; GnHAP - positioning of the laser tip without light emission + nano-hydroxyapatite; GLASER - laser tip positioning with light emission + placebo substance; GLASERnHAP - positioning by laser beam with light emission + nano-hydroxyapatite.

GLASER received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 2 sessions with a time interval of 24 hours. GLASERnHAP first received laser application and then the application of nanohydroxyapatite according to the manufacturer's recommendations. Before initiating laser therapy, the equipment was calibrated with a tester (MMOptics Ltda®, São Carlos, SP, Brazil).

The GnHAP volunteers were submitted to the application of Desensibilize Nano P on the vestibular surfaces of hypersensitive teeth with the aid of a Microbrush applicator (Microbrush, 3M ESPE, São Paulo, Brazil) for 10 minutes. Then, a rubber cup (Unid Microdont, São Paulo, SP, Brazil) mounted on a low speed handpiece (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to scrub the desensitizing gel on teeth for 20 seconds in each tooth, according to the manufacturer's specifications. GPLACEBO followed the same protocol used in Gn-HAP. In addition to the desensitization treatment, all GnHAP and GPLACEBO volunteers received the positioning of the laser tip to mimic the light emission produced in GLASER and GLASERnHAP. The noise emitted by the laser device during mimicry was simulated through the sound reproduction of a smartphone application (HD Voice Recorder - iPhone 6s, Apple®, Cupertino, California, USA).

Eligibility Criteria:
Inclusion criteria:

- The presence of at least one hypersensitive tooth;

Exclusion criteria:

* patients with systemic diseases;
* patients with pulpitis;
* patients with carious lesions;
* patients with defective restorations;
* patients with cleft enamel;
* patients with active periodontal disease;
* patients with analgesic medication;
* patients with pregnant or lactating women
* patients who have received professional desensitizing treatment in the last three months.
Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease

This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent or equivalent document (e.g., written information) as per country regulation prior to registration of any patient data
* Male or female patients aged 18 years or older with a diagnosis of Cushing's disease for whom surgery has failed or for whom surgery is not an option
* Patients must be treated with pasireotide s.c. started either at the first visit for this study or prior to study entry

Exclusion Criteria:

* Patients with ectopic ACTH-dependent Cushing's syndrome
* Patients with adrenal Cushing's syndrome
* Patients with Pseudo Cushing's syndrome
Effect of RYGB on Alpha- and Beta Cell Function and Sensitivity to Incretins in Patients With Type 2 Diabetes

The aim of the study is to investigate the effect of Roux-en-Y gastric bypass (RYGB) on pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in patients with pre-operative type 2 diabetes.

Primary hypotheses:

* After RYGB, the sensitivity to GLP-1 and GIP is improved (improved insulinotropic effect).
* After RYGB, the insulin secretion improves during an oral glucose tolerance test within 3 months postoperatively.
* After RYGB, the insulin secretion during intraveneous stimulation with glucose or non-glucose (arginin) is unchanged.

Design: 12 patients with type 2 diabetes will be recruited.

All subjects will undergo 11 study visits: four visits before, three visits at 1 week after surgery and four visits at 3 months postoperatively:

* Oral glucose tolerance tests (OGTTs) with measurement of GLP-1 and GIP secretion will be performed before and 3 months post-surgery.
* Hyperglycemic clamps with co-infusion of saline, GLP-1 or GIP will be performed in a randomised order at three separate study visits in randomized order before, 1 week and 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for RYGB in Denmark (ie. BMI \> 35 in the presence of obesity related co-morbidities as type 2 diabetes)
* Type 2 diabetes
* Pre-operative: Fasting plasma glucose ≥7,0 mmol/L or 2 hour plasma glucose ≥ 11,1 mmol/L (after pausing antidiabetic medication for a minimum of 3 days)
* Written informed consent.

Exclusion Criteria:

* Exclusion criteria for RYGB (psychiatric illness, obesity triggered by medical treatment for psychiatric illness, mental retardation, alcohol or drug abuse, severe heart-lung disease despite optimal medical treatment, previous serious problems with universal anesthesia, previous peritonitis, large hiatus hernia, diseases of the ventricle / previously complicated upper abdominal surgery, recurrent esophagitis, poor compliance).
* Type 2 diabetes where antidiabetic medication cannot be paused for 3 days.
* Pregnancy and breast-feeding.
* Hemoglobin \<7.0 mmol/L
Efficacy and Safety of Mate Extracts on Decrement of Body and Abdominal Fat in Obese Subjects

Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year.

The primary aim of the study was to investigate the effect of Mate extracts in Korean subjects on body fat and abdominal fat, double blind, placebo-controlled clinical trial.

Thirty obesity subjects with BMI ≥ 25 kg/㎡ and waist-hip ratio (WHR)≥ 0.90 for men and ≥ 0.85 for women were for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged 19 to 65 years
* 25 kg/m2 ≤ BMI ≥35 kg/m2
* Ability to give informed consent

Exclusion Criteria:

* Significant variation in weight (more 10%) in the past 3 month
* Cardiovascular disease, neurologic or psychiatric disease, renal, pulmonary and hepatic abnormalities
* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease (Crohn's disease) or gastrointestinal surgery (a caesum or enterocele surgery are included)
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the sutdy
* Allergic or hypersensitive to any of the ingredients in the test products
* Pregnancy or breast feeding
* Used antipsychosis drugs therapy within past 2 months
* History of alcohol or substance abuse (21 units/week over)
* Participation in any other clinical trials within past 3 months
Biomolecular Markers of Bone Metastasis

The goal of this clinical trial is to characterize the biomolecular profile of bone metastases to define the predisposing profiles of bone metastasis, in patients with breast or lung or renal carcinomas or of the gastroenteric or prostate tract with bone metastasis.

The main question it aims to answer is:

Is it possible to predict the progression of bone metastasis by identifying biomarkers as risk factors for bone metastasis?

Metastasization is a process that involves molecular change: potentially colonizable healthy tissues, particularly bone marrow, may "respond" to the production of factors released by the primary tumor, changing some of their funcional molecular characteristics in order to facilitate colonization by circulating tumor cells.

This study aims to describe the biomolecular profile of bone metastases. For this purpose, as per normal clinical practice, patients with carcinomas and who have developed bone metastases will undergo sampling of the metastases and primary tumors.

The activities will have multidisciplinary management. The study will include patients with carcinoma with bone metastases for whom the collection of biological material from the primary lesion and/or bone metastasis is an integral part of the diagnostic-therapeutic procedure or patients for whom, by clinical practice, a biopsy collection is performed because:

* histologic evaluation of the primary or metastatic lesion has been requested;
* a pathologic fracture to be treated surgically occurs;
* prophylactic orthopedic stabilization is required.

These samples will later be analyzed from a molecular point of view in order to identify a biomolecular profile that can help in defining profiles predisposing to bone metastasis and profiles predisposing to pathological fracture risk.

Unsupervised analysis of the emerged transcriptomes will be conducted:

1. regardless of tumor histotype (in order to highlight any common facilitating factors for bone metastasis and osteolytic activity),
2. by histotype,
3. by type of metastasis (osteolytic vs osteosclerotic).

To eliminate analysis error and bias, analyses will be conducted on fresh samples from needle biopsy or intraoperative sampling.

Emerging evidence on transcriptomic analysis will be validated with protein analysis methods and compared with evidence alreadỳ available in the literature.

The analysis being conducted for this study does not influence clinical practice, and all procedures are part of normal clinical practice in the management of patients with bone metastases from carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Patients with breast or lung or renal or gastroenteric tract or prostate with bone metastases
* Patients who knowingly express willingness to participate in the study after signing the written informed consent

Exclusion Criteria:

* None
The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.

1. Objective:

   To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT.
2. Patients:

   1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
   2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B点50Gy(+/-10%), concurrent platinum-containing chemotherapy（cisplatin or carboplatin）
   3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
3. Methods:

The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))
3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
4. ECOG\<2
5. Expected survival is longer than six months
6. Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L
7. ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN
8. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial

Exclusion Criteria:

1. Activity or uncontrol severe infection
2. Liver cirrhosis, Decompensated liver disease
3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
4. Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
5. Have suffered or combined with other malignant tumor
6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
7. A history targeted therapy or pelvic artery embolization
8. Artery-enous thrombosis within 6 months
9. Patients with autoimmune diseases
10. Complications, need to be treatment with drugs which may lead to liver or kidney injury
11. Patients with disease progression after chemoradiation
Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF

Different lowing blood pressure strategies have a different clinical efficacies. Blocking the angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months than 30% compared to Nifedipine( Adalat GITS ).

A total of 160 subjects will be included in two study groups. The Group 1 will receive 80-160mg Telmisartan per day, the remaining patients will receive Nifedipine ( Adalat GITS). Follow-up is 24 months. The conventional 12-lead ECG recordings at twice weeks interval and 24hrs holter monitor will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation. The target of Blood pressure after 3 months is less than 130/80mmHg. Concomitant therapy with B-blocker and acethydrazide are allowed for the target blood pressure during the study.


Eligibility Criteria:
Inclusion Criteria:

* Documented hypertensive patients with paroxysmal atrial fibrillation: ECG documentation of atrial fibrillation at least in one ECG recorded during the last 2 months prior to randomization plus additional ECG recording of sinus rhythm at least 12 hours after the above mentioned ECG documentation.
* Patients with hypertensive history were at least 5 years. Systolic pressure \> 140mmHg, \< 190mmHg, Diastolic pressure \> 85mmHg. \< 110mmHg.
* 40 \< Age \< 65 years

Exclusion Criteria:

* Strong clinical evidence for therapy with AT II/ACE inhibitors before 3 months of screening
* Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months
* Direct current (DC) cardioversion within the last 3 months
* Symptomatic bradycardia
* Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use
* Cardiac surgery or cardiac catheter ablation within the last 3 months
* Typical angina pectoris symptoms at rest or during exercise
* Known coronary artery disease with indication for intervention
* Valvular disease \> II degree
* Left ventricular ejection fraction \< 40%
* Diastolic blood pressure \> 110mm Hg at rest
* Symptomatic arterial hypotension
* Known renal artery stenosis
* Serum creatinine \> 1.8 mval/l
* Relevant hepatic or pulmonary disorders
* Hyperthyroidism manifested clinically and in laboratory
* Known drug intolerance for AT II inhibitors
* Females who are pregnant or breast feeding
* Females of childbearing potential who are not using a scientifically accepted method of contraception
* Participation in a clinical trial within the last 30 days
* Drug addiction or chronic alcohol abuse
* Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study
* Evidence of an uncooperative attitude