cyrilzakka/clinical-trials huggingface dataset:
Cervix Monitor for Elasticity and Length Measurements

Preterm birth is a leading global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die each year due to complications of preterm birth and in almost all countries with reliable data, preterm birth rates are increasing. Of the 14 million survivors per year, many face a lifetime of disability, including learning disabilities, visual and hearing impairments. Spontaneous preterm delivery (SPTD) is often multi factorial event, precocious cervical softening, shortening and dilatation are a common denominator. The majority of preterm births happen spontaneously, though some are due to early induction of labor or cesarean birth, typically due to medical maternal of neonatal conditions.

The uterine cervix has to provide structural integrity and mechanical resistance to ensure normal development of the fetus as the uterus expands to accommodate the fetus growth. Preterm delivery is closely related to a premature cervical ripening. The scientific bases for the proposed project is the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervix tissue is a collagen. Cervical ripening is the result of realignment of collagen, degradation of collagen cross-linking due to proteolytic enzymes. These processes affect the elasticity modulus of the cervical tissue. Therefore, assessment of cervix by a device measuring cervical elasticity and cervical length appears to be and adequate approach for identifying pregnant women at high risk of spontaneous preterm delivery. The primary cervical elasticity assessment currently used in clinical practice is relying on the evaluation of the cervix as "hard, medium or soft". In the scope of this project the investigators propose to develop and clinically validate a new and cost-effective device, Cervix Monitor for detecting cervix conditions leading to SPTD and its risk assessment. The CM will be based on measuring of the applied pressure to the cervix by a tactile sensor array and ultrasound measurement of cervix length .

Eligibility Criteria:
Inclusion Criteria:

1. Adult women age 21-44 years
2. Non-pregnant women, or
3. Pregnant women

Exclusion Criteria:

1. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
2. Ongoing or prior radiation therapy for abdominal or pelvic cancer
3. Recent (less than four months) pelvic surgery
4. Surgically absent uterus, rectum or bladder
5. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician
6. Severe abdominal or pelvic adhesions preventing access to pertinent anatomy
7. Known or suspected bleeding disorder
8. HIV or hepatitis B positive serology
9. Warty lesions on the vulva
10. Extensive varicose veins on the vulva
11. Active skin infection or ulceration within the vagina/vulva (Herpes infection)
12. Presence of a vaginal septum
13. Severe hemorrhoids
Micafungin Salvage Mono-therapy in Invasive Aspergillosis

To evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. To compare the efficacy and safety of the micafungin therapy with the active control arm

This is a phase II, multicentre, prospective, active-controlled, open-label, 2:1 randomised and parallel group clinical study.

Patients will be stratified according to the baseline infection status and the baseline neutropenic status:

* Intolerant to previous antifungal therapy
* Refractory to previous antifungal therapy; progression of infection
* Refractory to previous antifungal therapy; failure to improve In case, criteria for both intolerant and refractory are fulfilled at the same time the patient will be considered as refractory.
* Neutropenic (absolute neutrophil count (ANC \< 500 cells/mm3)
* Non neutropenic (ANC \>= 500 cells/mm3)

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with HSCT, acute leukaemia or myelodysplastic syndrome, with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and refractory or intolerant to amphotericin B or voriconazole products

Exclusion Criteria:

* Patients with allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, aspergilloma, sinus aspergillosis or external otitis; patient with previous salvage therapy for the current episode of fungal infection
Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy

This clinical trial is to determine an effective dosage and to study the safety of an investigational drug -lidorestat (IDD-676)- which is intended to stop or slow the progression of diabetic peripheral neuropathy.

Diabetic peripheral neuropathy is one of the most important and serious complications of diabetes. It can cause pain and loss of sensation, loss of mobility and lead to chronic wounds and amputations. Studies indicate 50% or more of people who have diabetes now have or will have significant neuropathy.

Several currently marketed or investigational drugs are available to treat the painful symptoms of diabetic peripheral neuropathy, but there are no approved drugs that have been shown to prevent or slow the progression of the neuropathy itself.

The current clinical trial is an early phase II study designed to investigate the safety of the investigational drug lidorestat (IDD-676) and to determine the effect of various dose levels on important biochemical processes in the pathology of diabetic neuropathy.

Participants who enter and complete this study will, if the agent is successful, help in a very important way to bring an effective treatment from research laboratories to widespread availability for treatment. On the basis of the results of this study, large scale studies will be undertaken to support application for product registration and distribution in the U.S. and other countries throughout the world.

Eligibility Criteria:
Inclusion:

* Clinical diagnosis of Type 1 or Type II diabetes with mild to moderate diabetic peripheral neuropathy.
* Healthy status except for diabetes
* Ability to make frequent clinic visits over a 7-month period.
* Willingness and ability to understand and sign consent form.

Exclusion:

* Pregnancy or breast feeding
* Presence of uncontrolled hypertension
* History or presence of significant kidney or liver disease.
Bioequivalence of An Oral Mercaptopurine Suspension 100 Mg / 5 Ml Versus Tablet in Healthy Male Subjects Under Fasting Conditions

The primary objective of this study is to determine whether the test product, mercaptopurine oral 100 mg/5 mL suspension, and the reference product, Purinethol® 50 mg tablets are bioequivalent. For this purpose the PK profile of 6-mercaptopurine (6-MP) will be compared after administration of a single dose of each of the two formulations, under fasting conditions. The secondary objective is to assess the safety and tolerability of the test product, mercaptopurine oral 100 mg/5 mL suspension.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, 18 years to 50 years inclusive at time of last administration of the IMP.
* Body Mass Index (BMI) between 18.5 and 30 kg/m2.
* Body mass not less than 50 kg.
* Medical history, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations: Findings clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
* Non-smokers.

Exclusion Criteria:

* Current alcohol use \> 21 units of alcohol per week for males.
* Regular exposure to substances of abuse (other than alcohol) within the past year.
* Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks prior to the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator.
* Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks before the first administration of IMP in this study.
* Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
* A major illness during the 3 months before commencement of the screening period.
* Subjects with a deficient, low or intermediate TPMT enzyme activity by means of phenotyping.
* Subjects who participated in previous azathioprine/mercaptopurine studies within six months will be excluded.
* Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
* Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of IMP.
* Diagnosis of hypotension or hypertension made during the screening period or current diagnosis of hypertension.
* Resting pulse of \> 100 beats per minute or \< 45 beats per minute during the screening period, either supine or standing.
* Positive testing for HIV and/or Hepatitis B and/or Hepatitis C.
* Positive urine screen for drugs of abuse.
* Positive urine screen for tobacco use.
* Subjects who plan to procreate within 12 weeks after IMP administration, or not willing to practice reliable forms of contraception during the study and for at least 12 weeks after the last dose of IMP.
* Immunization using a live organism vaccine within 4 weeks prior to the first dosing of IMP.
* Any specific IMP safety concern.
Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients

The goal of this clinical trial is to clinically validate a system for the monitoring of patients' respiratory function and automated oxygen treatment proposal using non-invasive ventilation devices in the treatment of intensive care patients with acute or chronic lung diseases exacerbations. Participants clinical parameters will be monitored and samples will be sent to a clinical laboratory for analysis (arterial blood pressure, heart rate, and respiratory rate will be continuously recorded, and FeO2 and CO2 will be measured with the help of an additional sensor).

This prospective experimental study is conducted in Pauls Stradins Clinical University Hospital (PSCUH) and Sleep Disease Center in Riga, Latvia. The study includes patients with respiratory failure and hypoxemia to whom NIV is indicated.

Participants clinical parameters are monitored and samples will be sent to a clinical laboratory for analysis.

Initial ventilation parameters will be defined by the clinician who performs the experiment.

During the validation phase, the investigators will obtain clinicians' final decision on the changes of the ventilation system parameters and compare it to our module proposal. That way it would be possible to estimate if the system is ready for the next step - fully automated closed-loop ventilation system development.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent to participate in the study;
* aged over 18 years;
* patients hospitalized with acute respiratory failure (indication to NIV therapy) with restrictive or obstructive lung disease

Exclusion Criteria:

* refusal to participate further in the study;
* age under 18 years;
* pregnancy;
* the patient is contraindicated for non-invasive lung ventilation
* during the study, the patients condition worsens in such a way that an active one is required medical intervention or continuation of the study may worsen the patients condition;
* complications related to NIV therapy or claustrophobia;
* chronic obstructive pulmonary disease and obstructive sleep apnea without documented hypoxemia (Sp02 and Sa02 \> 94%).
Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

* Introduction: Estrogen hormonal therapy associated or not with progestagen is the standard therapy for the treatment of hot flushes. However some women are not candidates for hormone replacement therapy for medical reasons or for choice.
* Main goal: Reducing the number of hot flushes per week
* Materials and Methods: A double-blind sulpiride versus placebo that includes selected randomized patients which show symptoms of menopause. The study will be conducted at HC Porto Alegre (Brazil) for 8 weeks of intervention. The expected result is a significant reduction in the number of hot flushes/day evaluated by daily questionnaires

It will be held 4 visits. The V0 (first one) to implement the consent form, review the inclusion and exclusion criteria and laboratory exams and deliver the diary book of hot flushes. The V1 (second visit) randomization and provide medication for the first 30 days. The V2 (third visit) to make the record diary of hot flushes already filled, to deliver new specifications and to provide medication for the last 30 days. The V3 (fourth visit) to evaluate the record diary of hot flushes already completed and to make a final evaluation of the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women in postmenopausal women with at least five moderate to intense hot flushes per day

Exclusion Criteria:

* Use of hormone replacement therapy or psychiatric drugs for at least 3 months
* Hypersensitivity to sulpiride
* Current or history of prolactin dependent tumor
* Treating breast cancer or treated
* Diagnosed or suspected pheochromocytoma
* Current use of levodopa
* Abnormal heart rhythm (QT prolongation, bradycardia low 55 beats per minute)
* Hypokalemia and other serious electrolyte disturbances
* Current or treated stroke
* Pregnancy or breastfeeding
Efficacy of the Transversus Abdominis Plane Block on Analgesia After Cephalic Duodeno-pancreatectomy

Pancreatic duodenectomy is one of the treatments offered to patients with neoplastic disease of the pancreas. In France, in 2018, 14,000 duodeno-pancreatectomies were performed, including 140 at the Hautepierre hospital at the Strasbourg University Hospital. Pancreaticoduodenectomy is a major surgery, causing significant postoperative pain that should be minimized through multimodal analgesia involving in particular locoregional anesthesia. Since 2019, the recommendations of the ERAS company concerning ERAS (Improved Rehabilitation After Surgery) after pancreaticoduodenectomy recommend the establishment of thoracic epidural analgesia in order to limit postoperative pain. When there is a contraindication to the placement of a thoracic epidural, in particular due to arterial and/or venous vascular reconstructions requiring potential perioperative curative anticoagulation, the administration of local anesthetic by pericatricial catheter is recommended. recommended. The Transversus Abdominis Plane (TAP) block has proven analgesic efficacy, safety and harmlessness in colorectal surgery.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years of age)
* Subject operated at HUS for cephalic duodeno-pancreatectomy between 01/01/2018 and 01/04/ 2022.
* Subject who has not expressed an objection to the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed his/her opposition to participate in the study
* Admission in intensive care unit after the operation
* Morphine treatment at home
* Drug addiction, weaned or not
HeartStart FRx Defibrillator Event Registry

This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.


Eligibility Criteria:
Inclusion Criteria:

* Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause
* Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered

Exclusion Criteria:

* AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
* AED used for training purposes.
AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

The study was designed to find the optimum AVN944 dose to use in combination with gemcitabine in patients with pancreatic cancer and see if the combination of the 2 drugs was more effective for treating pancreatic cancer than using gemcitabine alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed adenocarcinoma of the pancreas not eligible for curative intent resection with or without adjuvant radiation therapy
* Measurable disease as defined by RECIST criteria
* No prior chemotherapy for pancreatic cancer including no prior "radiosensitizing" chemotherapy
* Patients are candidates to receive gemcitabine as first line treatment for adenocarcinoma of the pancreas
* Age \> 18 years
* Karnofsky Performance Score of less than or equal to 60
* Patients must be recovered from the clinically significant effects of any prior surgery or prior radiotherapy
* Adequate bone marrow, hepatic and renal function as evidenced by:

  * Serum total bilirubin \< 2.0 mg/dL
  * AST/ALT (SGOT/SGPT) \< 4X the ULN for the reference lab;
  * Serum creatinine \< 2.0 mg/dL;
  * ANC \> 1.5 x 109/L;
  * Platelet count \> 100 x 109/L,
  * Hgb \> 9.0 g/dL
* Female patients of childbearing potential as well as fertile men and their partners who agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)
* Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.

Exclusion Criteria:

* Patients with a life expectancy \< 3 months
* Patients with known CNS metastases
* Patients with an uncontrolled active infection
* Prior treatment with an IMPDH-inhibitor
* Patients with known hypersensitivity to any of the components of AVN944 or gemcitabine
* History of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancers; cervical intraepithelial neoplasia, or localized prostate cancer with a current PSA of \< 1.0 mg/dL
* Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 14 days of the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). Clinically significant toxicities from this therapy must have resolved to \< Grade 2.
* Patients who are pregnant or lactating
* Myocardial Infarction within the past 6 months
* Patients with clinically significant intraventricular conduction delays
* Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
* History of solid organ transplant
* Known HIV or Hepatitis B or C (active, previously treated or both)
* Previous treatment under this protocol
Stellate Ganglion Block in Children With Autistic Disorder

The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Autistic Disorder in children is becoming increasingly more. The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as Autistic Disorder.
* Aged between 4 years old and 8 years old.
* No contraindications to stellate ganglion block.

Exclusion Criteria:

* Other significant physical or neurodevelopmental disorders.
* Other significant medical conditions
Study to Evaluate MET642 in Patients With NASH

A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NASH via biopsy, magnetic resonance elastography (MRE), or transient elastography (TE, FibroScan)
* Liver fat content ≥ 10% as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).

Exclusion Criteria:

* History of significant liver disease (eg, alcoholic liver disease, viral hepatitis, etc.) or liver transplant.
* Presence of cirrhosis on any prior liver biopsy (stage 4 fibrosis).
* Excessive consumption of alcohol.