cyrilzakka/clinical-trials huggingface dataset:
Thoraco-laparoscopic Partial Esophagogastrectomy for Management of Esophageal Cancer

Thoraco-laparoscopic partial esophagogastrectomy has emerged as a promising minimally invasive alternative, combining thoracoscopy and laparoscopy to reduce the trauma associated with open surgery.Early and intermediate-term outcomes provide critical information on both the oncological efficacy and functional benefits of the procedure. By examining recurrence rates within the first 12-24 months, this study will provide valuable insights into the oncological robustness of this approach compared to more invasive approaches.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with resectable esophageal cancer (stages I-III).
* Suitable for thoraco-laparoscopic partial esophagogastrectomy.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

* Presence of distant metastasis at diagnosis.
* History of previous esophageal or gastric surgery.
* Contraindications to laparoscopy or thoracoscopy.
A Pilot Study to Evaluate Alternative Viral Load Tests During Start of Antiretroviral Therapy

A pilot study of alternative viral load testing with samples collected in the clinic and at home compared to traditional viral load monitoring in participants engaged in HIV care. Approximately 15 participants starting ART, or working to suppress a detectable viral load, will monitor viral loads during regular clinic appointments and in intermediate time-points during their participation in this pilot study.

A pilot study of alternative viral load testing with samples collected in the clinic and at home compared to traditional viral load monitoring in participants engaged in HIV care. Approximately 15 participants starting ART, or working to suppress a detectable viral load, will monitor viral loads during regular clinic appointments and in intermediate time-points during their participation in this pilot study.

There are three planned research viral load evaluations in the trial, which may include but are not limited to the evaluations listed below:

1. CLINICAL CARE VIRAL LOAD - This will take place at the clinic during the regular clinical follow-up to confirm effective viral suppression.. During these visits an HIV viral load sample will be collected using traditional venipuncture methods and analyzed using a qualified commercial test. These plasma values may be used as a comparator with other viral load test results.
2. CLINIC TASSO COLLECTION - Participants will collect one or more Tasso device specimen(s) during in-clinic study visits. The main objective of these measurements is to evaluate HIV viral load monitoring using novel collection approaches with the supervision of trained study staff to minimize user error potential.
3. HOME TASSO COLLECTION - Participants will be provided with Tasso devices to use at home in between regular parent study visits. These devices will be shipped in real-time to Wistar Institute for archiving before HIV viral loads will be measured. The main objective of these measurements is to evaluate the feasibility HIV viral load monitoring using novel collection approaches at home.

Eligibility Criteria:
Inclusion Criteria:

* Persons living with HIV starting an ART regimen or working to suppress a previously detectable viral load ≥ 5,000 copies/mL

Exclusion Criteria:

* Persons living with HIV suppressed on ART regimen.
A Study of MF101 in Postmenopausal Women

This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.

Menopausal women often experience debilitating menopausal vasomotor symptoms and associated insomnia. Until recently, vasomotor symptoms were often treated with estrogens, which are very effective; however, randomized clinical trials have shown that postmenopausal combination hormone therapy increases the risks for stroke, cardiovascular events, and breast cancer. New, more effective, and safer treatments for menopausal vasomotor symptoms are therefore needed.

MF101, a botanical extract, is a non-hormonal investigational treatment being tested in a randomized, double-blind, placebo-controlled phase 3a clinical trial to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women. Approximately 1200 healthy post-menopausal women, aged 40-65, with moderate to severe hot flushes will be enrolled to determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo after 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria (limited):

* Confirmed postmenopausal women aged 40-65
* Provide written informed consent

Exclusion Criteria (limited):

* History of malignancy, with the exception of certain types of skin cancer or cervical cancer
* Known carrier of BRCA1 or BRCA2
* Abnormal mammogram or breast examination suggestive of cancer within 9 months of screening
* Endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of fibroids)
* Clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents
* History of deep vein thrombosis, pulmonary embolism, severe chronic diarrhea, chronic constipation, uncontrolled inflammatory bowel syndrome or disease (IBS or IBD), or unexplained weight loss
* Active liver disease or gall bladder disease
* History of chronic hepatitis B, hepatitis C, hepatitis within 3 months, or HIV infection
* Use of prescription medications or herbal/dietary supplements for the treatment of hot flushes or those with known estrogenic/progestogenic activity within required wash-out timeframes
* Use of selective receptor modulators (SERMs), aromatase inhibitors, gonadotropin-releasing hormone agonists, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin or clonidine within required wash-out timeframes
* Chronic use of morphine or other opiates
Analgesic Effect of Oral Glucose in Neonates

Background: Male circumcision is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. It was thought that the newborn baby does not experience pain because of incompletely developed nervous system. However, it has been shown that neurological system known to be associated with pain transmission and modulation, is intact and functional.

OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after circumcision compared with normal saline.

STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial.

POPULATION: We will include full term neonates, who will be recruited from the inpatient nursery at Makassed General Hospital over a 1-year period.

OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured using the Neonatal Infant Pain Score.

Secondary outcome is to assess effect of 30% glucose oh physiologic parameters


Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age: 37 weeks-42 weeks
* Birth weight: 2500 grams-4000 grams
* Apgar scores a minimum of 7 at 1 and 5 minutes respectively
* Heart rate between 100 and 160 per minutes
* Blood O2 saturation of at least 95%
* No recognized congenital abnormalities

Exclusion Criteria:

* They were transferred to the neonatal intensive care unit (NICU)
* They required respiratory support
Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)

The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities.

The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) e30 kg/m2 in patients with or without comorbidities, or BMI \>27 kg/m2 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia.
* stable body weight (variation \<5 kg within 3 months prior to screening visit);

Exclusion Criteria:

* History of very low-calorie diet within 6 months prior to screening visit; or history of surgical procedures for body weight loss (eg, stomach stapling, bypass);
* Presence of any clinically significant psychiatric , neurological or endocrine disease
* Presence of treated or untreated type 1 or type 2 diabetes);
* SBP \>165 mmHg and/or DBP \>105 mmHg on 2 consecutive visits from the screening to the inclusion visit;
* History of myocardial infarction or unstable angina pectoris within 6 months prior to screening visit; and history of stroke within 6 months prior to screening visit;
* Administration of anti-obesity drugs or other drugs for body weight reduction within 3 months prior to screening visit;

The investigator will evaluate whether there are other reasons why a patient may not participate.
Study of Variations of Pleural and Esophageal Pressures Under Mechanical Ventilation After Lung Transplantation

The primary objective of the study is to determine the correlation between mean pleural pressure and oesophageal pressure in the immediate aftermath of bi-pulmonary transplantation.

In this research, oesophageal pressure will be measured by a nasogastric tube with an esophageal balloon (also suitable for feeding the patient) usually installed at the time of transplantation, pleural pressure will be measured by several Pleurocath-type catheters (Prodimed Inc, France) which the thoracic surgeon will have positioned at the end of the surgery without additional skin intrusion.

Pulmonary transplantation is a model of acute lung injury due to ischemia-reperfusion phenomena responsible in 1 in 4 patients for the occurrence of primary graft dysfunction (DPG), which penalizes graft prognosis in the short to medium term. The survival of transplant patients. Furthermore, the post-operative period is a complex period in which multiple hemorrhagic, immunological, infectious, and neuromuscular complications may arise that may require prolonged mechanical ventilation. At present, there are no data on the measurement of pressure in pleural space after pulmonary transplantation. Achieving this measurement would make it possible to adapt the settings of the ventilator to both the acute phase in the case of DPG and to a later phase in case of mechanical weaning. In the case of bi-pulmonary transplantation, before the thorax is closed, each patient benefits from the systematic placement of bilateral anterior and posterior thoracic drains to prevent the formation of fluid effusions (hemothorax, pleurisy) and / or gases (pneumothorax ) Which would impede ventilation and compromise gas exchange. These drains are gradually withdrawn during resuscitation usually after weaning mechanical ventilation

Eligibility Criteria:
Inclusion Criteria:

- Adult patient admitted in the Respiratory Distress and Severe Infections Intensive Care Unit in the postoperative period following a double lung transplant after written informed consent.

Exclusion Criteria:

* Age less than 18 years, Pregnancy, breast feeding, adults under guardianship or under safeguard justice, not beneficiaries of a social security scheme, persons deprived of liberty by a judicial or administrative decision , those hospitalized without consent Single lung transplant
* Open chest at the end of transplantation
* high flow pleura-pulmonary fistula (Contraindication to the establishment of a nasogastric tube proven presence of esophageal varices esophageal tumor Surgery of the esophagus of less than 1 year
GLP-1's Effect on Cardiac Parameters and Mesenteric Blood Flow

to investigate the effect of the human incretin hormone GLP-1 on mesenteric blood flow and cardiac parameters

to investigate the effect of the human incretin hormone GLP-1 on mesenteric blood flow and cardiac parameters, in healthy subjects, 4 arms, task force monitor

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* medical conditions
Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission and inflammatory serum markers.

The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine (0.5 mg/kg) in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission measured by Magnetic Resonance Imaging Spectroscopy and inflammatory serum markers (IL-6, TNF-alpha).

Eligibility Criteria:
Inclusion Criteria:

* Treatment-Resistant Depression (Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies)
* Acceptance of participation via the informed consent

Exclusion Criteria:

* Psychiatric comorbidity (except anxiety related disorders)
* Substance abuse or dependence in the previous 3 months
* Evidence of structural abnormalities in brain imaging
* Pregnancy
* Previous hypersensitivity to ketamine
* Heart failure or insufficiency
* Familial or personal history of psychosis
* Glaucoma
* Major neurological disease
* Uncontrolled systemic arterial hypertension
* MRI contraindications
* Non-acceptance of participation via informed consent
In-Vivo Validation of Novel Diagnostic Devices Versus Visual ICDAS-II Criteria in Detection of Early Occlusal Caries

The diagnosis of non-cavitated occlusal caries is considered problematic and still a challenge for dental professionals. It affects 60-90% of schoolchildren and adults.Clinically, caries commonly is performed by methods of visual examination and subjective assessments of, translucency, color and dental hardness, as well as by means of radiographic imaging. These methods, however, show low sensitivity for occlusal caries detection.Some of these methods are light based fluorescence devices taking the advantages of the fluorescence properties of the hard tissues of the tooth as there is a difference in fluorescence observed in sound and demineralized dental tissues.Other methods based on electrical impedance has been used. These devices aimed to employ the AC Impedance Spectroscopy Technique (ACIST) In order to record variations in mineral density throughout the tooth, not just the surface, ACIST sends a low amplitude microamp current from the sensor tip contact through the pulp, dentin, and enamel.Hence, a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) and impedance spectroscopy based device (CariescanPRO) in comparison with the visual examination and digital radiography in detection of initial pits and fissures caries.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 21 to 50 years.

  * Patient at least has one posterior pits and fissure occlusal caries.
  * No gender restriction
  * Co-operative patients who signed the informed consent.
  * Good general health
  * Acceptable oral health

Exclusion Criteria:

* Pregnancy.

  * Disabilities.
  * Systemic disease or severe medical complications.
  * Allergic history concerning methacrylate.
  * Rampant caries.
  * Heavy smoking.
  * Xerostomia.
  * Lack of compliance.
  * Evidence of severe bruxism, clenching, or temporomandibular joint disorders
A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia

This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.


Eligibility Criteria:
Inclusion Criteria:

* Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash

Exclusion Criteria:

* Female patients with reproductive potential
* Active herpes zoster skin rash
* Current or anticipated treatment with acupuncture, TNS, or steroids
* Current or anticipated use of topical analgesic agents with PHN
* Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks
A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer

The purpose of this study is to test the hypothesis that an intervention of lifestyle modification will positively impact women with breast cancer who are overweight and/or obese. To that end, our primary endpoint is to examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.

* Primary endpoint: To examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.
* Secondary endpoint: To assess the impact of such intervention on lipid profiles and hemoglobin A1C. The study group will be compared with a historical control group of patients with early stage breast cancer who are obese or overweight who were not given the intervention
* Secondary endpoint: To examine whether an active intervention program will lead into longstanding lifestyle modification in breast cancer patients with a BMI greater or equal to 25.

Eligibility Criteria:
Inclusion Criteria:

* DCIS
* Women with stage 0 - III breast cancer (histologic type ductal or lobular)
* BMI \>=25
* Patients must have completed all chemotherapy
* Patients may be on hormonal therapy or radiation therapy
* Age \>= 18 years old to 89 Years old
* Patient must be medically stable and without significant impairments that would preclude following the proposed intervention regimen.
* Time of diagnosis: patients enrolled are within 1 month to 18 months post-diagnosis.

Exclusion Criteria:

* Metastatic breast cancer patients and patients with inoperable or active loco-regional disease.
* Patients following alternative/complementary diets or taking high dose antioxidant supplements.
* Patients with a physical/psychiatric impairment that would seriously impair their physical mobility.
* Patients who are currently suffering from severe nausea, anorexia or other diseases affecting health (e.g. arthritis and multiple sclerosis).
* Patients younger than 18 and older than 89 years.
Oto Smartphone App in Treating Tinnitus Amongst Adult Patients Compared with Standard Talking Therapies

A study that looks at treating tinnitus and its associated burden, insomnia and quality of life effects with a smartphone app when compared with the talking therapies already offered on the national health service. Three separate questionnaires will be used to collect this data from patients at regular time intervals.

Single-site randomised controlled study looking at tinnitus burden, insomnia severity and quality of life in adults with chronic primary subjective tinnitus when using Oto smartphone app compared with National Institute for Health and Care Excellence (NICE) approved tinnitus retraining therapy. This will be assessed objectively through questionnaires at the baseline meeting, one month, three months and six months.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (male or female) aged over 18 years of age presenting to NHS ENT and hearing services with primary non-pulsatile tinnitus irrespective of hearing.
* Patients must be suffering from tinnitus for a minimum of 3 months
* Patients that have a willingness to use as well as have access to a smartphone device capable of running Oto.
* Willing and able to provide written informed consent.
* Those that would be offered tinnitus retraining therapy (TRT) as management for their primary tinnitus

Exclusion Criteria:

* Patients with secondary tinnitus as confirmed by magnetic resonance imaging (MRI).
* Patients undergoing any other tinnitus therapies concurrently (including hearing aids / implants). Previous tinnitus therapies including CBT in the past are accepted.
* Patients who are not willing to use the app due to not having a suitable phone to download the application or due to own limitations in working Oto.
WEANING-Study: "Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings

Background:

One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require tracheostomy). As shown previously, predisposing factors for tracheostomy are hematoma volume, hemorrhage location, presence of intraventricular hemorrhage (IVH), and occlusive hydrocephalus as well as presence of COPD (Huttner HB et al 2006 CVD).

Sustained restricted vigilance and impaired consciousness after ICH is likely to result in failure of extubation, raise in incidence of ventilator-associated pneumonia, increased amount of sedative drugs and prolonged duration of neurocritical care.

Hence an early tracheostomy may be beneficial in terms of reduced duration of mechanical ventilation.

Basic hypothesis:

Compared to patients with conventional ("late") tracheostomy between day 12 - 14, patients with "early" tracheostomy within 72h after admission will have:

* shorter cumulative time of mechanical ventilation
* less incidence of ventilator-associated pneumonia
* less consumption of sedative drugs
* shorter duration of stay in neurocritical care unit

Randomization:

Consecutive eligible patients are randomly assigned to Either "early" tracheostomy within 72h after hospital admission Or "late" tracheostomy (= control group; undergoing conventional tracheostomy between day 12 - 14 if extubation fails) Both groups receive plastic tracheostomy


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring intubation / mechanical ventilation
* Supratentorial intracerebral hemorrhage (including:)
* primary spontaneous ICH (lobar / deep)
* ICH related to anticoagulant therapy
* with or without intraventricular hemorrhage
* with or without occlusive and / or communicating hydrocephalus
* Hematoma volume \>0 ml and \<60 ml
* Age 18 - 85 years
* Informed consent (legal representative)

Exclusion Criteria:

* Patients with elective intubation/ventilation for EVD placement
* Patients with "do not treat" / "do not resuscitate" orders, severe co- morbidity and life expectancy of less than 3 months
* Absent consent of relatives for invasive (neuro-)critical care
* Contraindication for tracheostomy
* Other than primary supratentorial ICH or supratentorial ICH related to oral anticoagulants
* Pre-existing COPD (known/treated)
* Pre-existing congestive heart failure (≥3 NYHA)
* Pre-existing modified Rankin Scale (≥4)