cyrilzakka/clinical-trials huggingface dataset:
Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer

Prostate cancer is the most common non-skin cancer diagnosed among men and the second leading cause of male cancer deaths in the United States. In 2013, it is estimated that 29,270 men have died from prostate cancer. Although radiation and surgery are quite effective for localized disease, there is no effective cure for men who present with metastatic prostate cancer as the 5-year relative survival rate is only 28%.

Currently, androgen deprivation therapy (ADT) via medical or surgical castration is the standard first-line therapy in men with metastatic disease but castration-recurrent prostate cancer (CRPC) eventually emerges with a median time of 18-24 months. Once CRPC develops, secondary hormonal manipulation, chemotherapy, and immunotherapy are marginally effective.

Given the dismal prognosis of metastatic prostate cancer, new ideas and novel approaches must be explored to improve the clinical outcome. In this regard, recently emerging data suggest that local tumor control may enhance the effectiveness of subsequent systemic therapies. Therefore, in this proposal, the investigators have designed a Phase I/II study in which they will prospectively evaluate the safety and feasibility of cytoreductive prostatectomy in men with newly diagnosed mPCa.


Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate
* Very high risk PCA (PSA ≥ 20 oder Gleason Score ≥ 8 oder ≥ cT3) and/or oligometastasierte PCA (T any N positive M any, oder T any N any M positive)
* ≤5 bone metastasis
* ≤75 years
* Ability for informed consent
* Clinically no infiltration into the rectum or pelvic wall
* Clinically no visceral metastasis
* Male, \>18 Jahre
* Fit for surgery
* ECOG Performance Status 0 oder 1

Exclusion Criteria:

* Male, \< 18 Jahre
* \> 5 bone metastasis
* \> 75 years
* No ability for informed consent
* Clinically infiltration into the rectum or pelvic wall
* Not fit for surgery
* Clinically visceral metastasis
AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects

This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male Japanese subjects aged 20 to 45 years (inclusive)
* Have a body mass index (BMI) between 18 and 27 kg/m 2 (inclusive) and weigh at least 50 kg.least 50 kg.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* Any clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, haematology or urinalysis as judged by the Investigator and/or Sponsor.
* Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1.
Evaluation of Accuracy of Computer Guided Versus Conventional Segmental Sandwich Osteotomy With Immediate Implant Placement in Vertically Deficient Anterior Maxilla

In conventional segmental sandwich osteotomy technique the moving the transport segment inferiorly to increase the vertical height causes the segment to move bucco-palatally, increasing the horizontal defect. So using the computer guided in segmental sandwich osteotomy and fixation the transport segment hopefully will reduce the bucco-palatal tipping.


Eligibility Criteria:
Inclusion Criteria:

* Patients with vertically deficient anterior maxillary ridge a minimum 10 mm. height of alveolar bone.
* Patients with medical history that did not hinder implant placement (uncontrolled diabetes) and adequate proper oral hygiene.
* Patients of adequate alveolar bone width.
* Both genders males and females will be included.

Exclusion Criteria:

* General contraindications to implant surgery.
* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Untreated periodontitis.
* Poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnant or nursing.
* Substance abuse.
* Psychiatric problems or unrealistic expectations.
* Severe bruxism or clenching.
* Immunosuppressed or immunocompromised.
* Treated or under treatment with intravenous amino-bisphosphonates.
* Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
* Active infection or severe inflammation in the area intended for implant placement.
* Need of bone augmentation procedures at implant placement.
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly followed.
* Referred only for implant placement or unable to attend a 5-year follow-up.
* Requiring only single implant-supported crowns.
Introduction of an Enriched Evening Meal on the Feeding Behavior of Institutionalized Residents

The main objective of this study was to evaluate and compare 6-month calorie intakes between a group of patients receiving a standard dinner and a group of patients whose evening meal is "improved"; compliance will be assessed on a food card with 5 levels of consumption: no (0%), 25%, 50%, 75%, all (100%). This per patient per meal food card will be prepared 3 days per month for 6 months and will, from the total calorie intake of each dish, estimate calorie intake ingested per day on all meals of the day.

The secondary objectives of this study are to evaluate the two groups for the following:

A. The difference between 0 and 6 months in: the patient's weight, calorie intake, serum prealbumin, albumin and CRP, blood sugar for diabetic patients.

B. Monthly evolution over 6 months: calorie intake, the patient's weight. C. The quarterly trend over 6 months: serum prealbumin, albumin and CRP, blood sugar for diabetic patients.

D. Comorbidities and mortality. E. the risk of morning hypoglycaemia for diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* The subject or his/her representative must be given free and informed consent and must have signed the consent
* The subject must be affiliated with or beneficiary of a health insurance plan
* The subject has lived for at least 3 months in the institution
* The subject is fed by mouth only

Exclusion Criteria:

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The subject or his/her legal representative refuses to sign the consent
* It is not possible to correctly inform the subject or his/her representative
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients

To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CHF or COPD
* current body weight less than 6 months ago
* BMI \>=20 and \<=30 kg/m2
* CHF: LVEF \>=45% measured within the past 6 months
* symptom status equivalent to NYHA class II to IV
* biochemical abnormalities for total cholesterol, serum uric acid, abnormal high CRP
* on standard therapy of CHF including ACE inhibitors and beta blockers
* COPD: symptom status equivalent to GOLD standard class II to IV
* FEV1 \< 80%
* FEV1/FEV \< 70%

Exclusion Criteria:

* significant oedema in the time of screening and randomisation
* concomitant inflammatory diseases
* active infections including HIV and AIDS
* liver failure
* chronic renal failure (sCr\>1.5mg/dL) or cardiac pacemaker
* acute or chronic infections
* insulin treated diabetes mellitus
* patient with established diagnosis of cachexia
* life expectancy of less than 6 months in the opinion of the investigator
* medications that impair sex hormone synthesis, secretion or function
* patients with psychiatric diseases
* body weight loss \> 5% during the last 6 months or \> 10% during the last 10 months
* suspected allergy to any component of the investigational product(s)
* fish oil supplementation within 3 months prior to the study entry
* taking vitamin supplements in doses greater than the Recommended Daily Allowances
Physiologic Burden to the Surgeon During Orthopaedic Surgery

The investigator's plan to quantify the physiologic impact of orthopaedic surgery on the surgeon and operating team.

The prevalence of musculoskeletal pain among orthopaedic surgeons is inordinately high. Poor surgical ergonomics and physiological stress have been shown to impair surgical performance and cause injuries. Various approaches, techniques and instruments have been designed to improve surgical outcomes for patients. There has been nominal research in the area of occupational hazards such surgeries impose upon the surgeon. Several studies have demonstrated a higher risk of cervical spondylosis and rotator cuff tears amongst surgeons. However, little has been studied on the impacts of some of these approaches, techniques, and instruments on surgeons' physiologic measures.

The investigator's will use The Hexoskin Smart Vest to capture physiological data from surgeons during the study.

Eligibility Criteria:
Inclusion Criteria:

* Orthopaedic surgeons, orthaopedic fellows, and orthopaedic residents.
* Up to 750 surgical patients of the participating surgeons will be included for demographic chart review.

Exclusion Criteria:

* Non-surgeons, fellows, or residents.
* Female participants that are or become pregnant.
Orbital Artery Doppler Ultrasound in Brain Death

Brain death is the irreversible loss of all activity in the brain, brainstem, and cerebellum, the part of the central nervous system that remains inside the skull.

The clinical diagnosis of brain death should be supported by ancillary tests that provide information about cerebral blood flow or electrical activity in the brain. Some of the ancillary tests that evaluate cerebral blood flow include transcranial Doppler ultrasonography (TDUS), computed tomography (CT) angiography (CTA), and catheter-based cerebral angiography.

This study hypothesized that Orbital Doppler ultrasonography (ODUS) alone is more effective than TDUS in detecting intracranial blood flow in diagnosing brain death. To this end, the investigators examined the results of ODUS in patients diagnosed as brain dead who underwent CT angiography.


Eligibility Criteria:
Inclusion Criteria:

* suspected brain death

Exclusion Criteria:

* eye surgery,
* uncontrolled diabetes mellitus,
* facial trauma,
* hypothermia,
* hypotension (systolic pressure \< 100 mm Hg)
* endocrine-metabolic coma
A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders

The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by stimulation of the vagus nerve. The study will compare two methods of stimulation to determine if there is a difference in the two methods.


Eligibility Criteria:
Inclusion Criteria:

* Female patients 12-18 years old with chronic idiopathic nausea, function abdominal pain, dyspepsia and/or irritable bowel syndrome
* English Speaking

Exclusion Criteria:

* Patients who are unable to stand upright during the heart rate variability recording
* Patients with a known bleeding disorder
* Gastric or cardiac pacer or defibrillator
* Poor circulation in lower limbs
* Swollen or inflamed outer ear
* Epilepsy
* Abdominal or inguinal hernia
* Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc.
* Requires new medication during the 8 weeks of the study that may affect gastrointestinal symptoms, vagal modulation or immune response
* Inability to answer questionnaires or report pain on a 0-10 visual analog scale.
Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

Chronic gynaecological pain is a major medical problem that affects 20-30% of women at different moments of their life. This largely neglected issue has a significant impact on the sexual and conjugal life of women suffering from it as well as on their psychological health. Furthermore, this kind of pain is not well understood, often misdiagnosed or even totally ignored. Also, treatment is limited and not extensively studied. This study aims at better understanding and treating gynaecological pain. The focus of the study will be provoked vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic floor physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva. The treatment efficacy will be assessed in 234 women (aged from 18-45 years old) suffering from provoked vestibulodynia recruited in 4 hospitals (CHUS, Jewish General Hospital, Royal-Victoria Hospital, CHUM St-Luc).

This is a randomised controlled trial comparing the impact of multimodal physiotherapy treatments to topical lidocaine in women suffering from provoked vestibulodyina. The first treatment consists of 10 sixty minutes weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises. The second treatment is a night time application of lidocaine to the vulva for 10 weeks. Physiotherapists will then evaluate women's pain and sexual function right after the treatment and 6 months later.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe pain in at least 90% of sexual intercourses.
* Moderate to severe pain during the cotton-swab test at one of more vestibule regions (5/10 minimum pain evaluation on the verbal pain intensity scale).
* Pain limited to the vestibule during vaginal penetrations and during activities applying pressure on the vestibule.
* Provoked vestibulodynia lasting at least 6 months prior to the study and diagnosed by a standardised gynaecologic exam protocol by one of our collaborator.

Exclusion Criteria:

* Major psychiatric condition or pelvic pathology associated with a genital pain problem (e.g.: dyspareunia).
* Use of medication that could influence pain perception.
* Actual or past pregnancy.
* Vulvar or vaginal surgery
* Post-menopausal state
* Unwillingness to restrain from other treatments till the 6 months post-treatment evaluation.
* Urogynaecologic symptoms (urinary/anal incontinence, pelvic organs prolapsus, urinary/vaginal infection active or during the last 3 months).
* Incapacity to have sexual intercourse including vaginal penetration during the last 6 months.
* Physiotherapy treatments or lidocaine application prior to the study
Antibacterial Effect of Guava Leaves Extract Mouthwash Compared to Chlorhexidine Mouthwash in High Caries Risk Patients

This trial is to test the antibacterial effect of Guava leaves extract mouth wash compared to Chlorhexidine mouth wash in high caries risk patients.

Also salivary pH and patient satisfaction to taste will also be tested.

This study is conducted to evaluate the effect of Guava leaves extract mouth wash on anti-bacterial activity against streptococcus mutans, salivary pH and patient satisfaction to taste compared to Chlorhexidine mouth wash.

P: Population with high caries risk patients I: Intervention by Guava leaves extract mouthwash C: Control is Chlorhexidine mouthwash O1: The primary outcome is antibacterial activity. O2: The secondary outcome is salivary pH O3: The tertiary outcome is patient satisfaction to taste

Eligibility Criteria:
Inclusion Criteria

1. High caries risk patients
2. 18-50 years
3. Healthy cooperative patients
4. Males or Females

Exclusion Criteria

1. Medically compromised patients
2. Patients with any systemic disease that might affect the salivary flow
3. Allergy to any of the ingredients
4. Patients with physical limitations that might affect normal tooth brushing and mouth rinsing
5. Presence of intraoral infections
6. Currently using any mouth rinse
7. Smokers
8. Use of antibiotics in the previous 30 days
Transcranial Direct Current Stimulation (tDCS) as a Cognitive Enhancer for Patients With Alzheimers Disease

The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a cognitive enhancer for patients with Alzheimer disease.

Transcranial direct current stimulation (tDCS) is a neuromodulation technique, that are applied to the brain by using two electrodes. These electrodes are placed on the scalp. The current is low intensity, usually 1-2 milliampere. tDCS may affect cognitive functions by increasing cortical excitability. tDCS is regarded as a safe treatment approach. In the present study, participants will undergo six stimulations. The effect of all stimulations swill be measured with neuropsychological testing before the first (pre) and after the sixth tDCS stimulation (post).

The present study is a randomized controlled study (RCT) and will use tDCS to stimulate left temporal lobe and hopefully improve verbal memory functions. A total of 30 patients with Alzheimer disease will receive tDCS treatment for 30 minutes, six times. Half of the patients will undergo sham stimulation. These six stimulations will be executed during 10 days. Patients will be tested with neuropsychological tests before the first stimulation and after the last stimulation to assess the effect of the treatment. Patients will be retested six months later in order to investigate long-term effects ot the stimulation. The main hypothesis in the present study is that tDCS stimulation will lead to significant improvements in verbal memory functions.

Eligibility Criteria:
Inclusion Criteria:

* Alzheimers disease according to (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association).
* The cognitive impairment and decline must be documented by cognitive / neuropsychological testing and from an informant.

Exclusion Criteria:

* Stroke,
* Cancer,
* Psychiatric disorders (major depression, psychosis) or diseases / injuries in the central nervous system.
Quality of Life and Acupuncture on Chronic Pain: A Randomized Study Before and After Performing

Chronic pains can affect the life quality. This study has performed in the first time in Mashhad.The purpose of the present study was to examine the effect of acupuncture on the life quality of 150 patients who suffered from chronic pain. Some people like performing acupuncture because they believed it's free of risks and beneficial.

In order to achieve this purpose, we had examined the life quality of the patients before and after acupuncture. This study was randomly performed on 150 patients aged between 17-75. They were suffering from chronic pain.

The questionnaire is based on WHO QOL. The questionnaires were filled out once before acupuncture and once 12 weeks after it.

This study was completed on time.

Eligibility Criteria:
Inclusion Criteria:

* aged between 17 - 75 years old,
* suffering from arthritis pains,
* migraine backaches,
* muscular spasms,
* pains in the neck, and in the knee
* duration of disease over 1 year

Exclusion Criteria:

* tacking pain relief
* pregnant women
Comparison of ProSeal Laryngeal Mask Airway, LTS-D and I-gel in Mechanically Ventilated Patients

The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation undergoing elective surgical procedure.

The study aims to draw a comparison between ProSeal LMA, i-gel and LTS-D supraglottic airway devices in terms of the efficacy and safety in anaesthetised patient on Mechanical ventilation undergoing elective surgical procedure.

Methodology: A prospective randomized control study conducted on 150 patients undergoing elective surgical procedure under general anaesthesia at Dr Sushila Tiwari Hospital and Government medical college, Haldwani.

Following detailed pre-anaesthetic check-up, informed written consent was taken from patient fulfilling the required criteria. Patients were randomly allocated into 3 groups namely Group I (i-gel, n=50), Group P (p-LMA, n=50) and Group L (LTS-D, n=50) by online generated randomization.

Standard general anaesthesia protocol was followed and once adequate depth was achieved i-gel or p-LMA or LTS-D appropriate for weight or / and height was selected and inserted. An effective airway was confirmed and device was fixed from maxilla to maxilla.

The three groups were compared with respect to number of Insertion attempts, ease of insertion of device, time taken for placement of device, airway sealing pressure, ease and number of attempts of gastric tube placement and complications noted if any.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) class I/II.
* Age 20-60years of either sex.
* Weight between 40-60 kg of either sex.
* Elective Surgical procedures of duration of 1-1½ hour with no need for endotracheal intubation.

Exclusion Criteria:

* Patient with risk factors for difficult airway. (Mouth opening of \<2cm, Mallampati class 4, limited neck extension, history of previous difficult intubation)
* Any known pulmonary and cardiovascular diseases.
* Risk of aspiration. (Full stomach, hiatus hernia, gastro-oesophageal reflex disease, emergency surgery)
Dynamic Web-Based Interventions to Improve Update of Preventive Health Recommendations in IBD

To understand patient knowledge, attitudes, and beliefs around the uptake of vaccinations and malignancy screening through patient focus groups/qualitative interviews. To develop and pilot an interactive website that will provide customized recommendations for individual patients with IBD and direct them as relevant to five 60-90 second customized, animated videos (influenza, pneumococcal, and zoster vaccinations, bone health, and skin cancer screening). This content will be pilot-tested with patients to fine-tune the educational modules.


Eligibility Criteria:
Inclusion Criteria:

* enrollees in the internet-based cohort IBD Partners, age 18 and older

Exclusion Criteria:

-
Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation

Benzodiazepines are usually a secondary drug of abuse-used mainly to augment the high received from another drug or to offset the adverse effects of other drugs. Few cases of addiction arise from legitimate use of benzodiazepines. Pharmacologic dependence, a predictable and natural adaptation of a body system long accustomed to the presence of a drug, may occur in patients taking therapeutic doses of benzodiazepines. However, this dependence, which generally manifests itself in withdrawal symptoms upon the abrupt discontinuation of the medication, may be controlled and ended through dose tapering, medication switching, and/or medication augmentation. Due to the chronic nature of anxiety, long-term low-dose benzodiazepine treatment may be necessary for some patients; this continuation of treatment should not be considered abuse or addiction.

previous study reported that The results of the study are important in that they corroborate the mounting evidence that a range of neuropsychological functions are impaired as a result of long-term benzodiazepine use, and that these are likely to persist even following withdrawal. The findings highlight the residual neurocognitive compromise associated with long-term benzodiazepine therapy as well as the important clinical implications of these results.


Eligibility Criteria:
Inclusion Criteria:

* age from 18 years to 50 years
* No history of neurological or medical illness

Exclusion Criteria:

* intelligence score more than 80