cyrilzakka/clinical-trials huggingface dataset:
NK-1 Antagonism of SLV317 in Humans

The primary objective is to determine the effect of a single oral dose of 250 mg SLV 317 on substance P-induced venodilation in the hand vein of healthy male volunteers as compared to placebo.

This will be a double-blind, placebo-controlled, oral single dose cross-over study. 18 healthy male volunteers will receive 250 mg SLV 317 or placebo in randomised order with a minimum wash-out period of one week between the two administrations.

Pharmacodynamic assessments will be performed up to 4.25 hours post-dose using the dorsal hand vein compliance technique. After obtaining venoconstriction via infusions of phenylephrine, substance P will be co-infused intermittently to induce venodilation. Substance P infusions will be separated by intervals of 45 minutes in order to prevent the well-known occurrence of tolerance.

Venous blood sampling for pharmacokinetic evaluation will be performed up to 24 hours post-dose.

Safety will be assessed by measuring ECG, pulse rate, blood pressure, haematology, blood chemistry, urinalysis, and by monitoring of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Male non-smoking volunteers, age: 18-45, with a body mass index (BMI) in the range from 19-26 (kg/m2), inclusive
* Good health as determined by medical history, physical examination, electrocardiogram, serum/urine biochemistry and haematology
* A lying blood pressure after resting for 5 minutes between 100 150 mmHg (systolic) and 50-90 mmHg (diastolic)
* A lying heart rate (ECG) after resting for 5 minutes between 45 and 100 beats/min.
* Able and willing to give written informed consent

Exclusion Criteria:

* Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, smoking, arterial hypertension, hyperhomocysteinaemia)
* Evidence of cardiovascular, gastrointestinal/hepatic, neurologic/psychiatric, respiratory, urogenital, haematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery, or other relevant diseases as revealed by history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constituting a risk factor when taking the study medication
* A known history of epilepsy or with relatives with epilepsy
* Use of any drugs (prescribed and non-prescribed) within the last 2 weeks with the exception of paracetamol up to 48 hours before start of the study
* Any acute or chronic illness
* Participation in clinical trial or blood donation within 2 months before the study
* Drug and/or alcohol abuse or use of alcoholic beverages within 48 hours prior to the study or with a positive drug or alcohol test
* Use of tobacco or nicotine in any form or with a cotinine urinary level above 500 ng/ml
* Carriers of the Hepatitis B surface antigen (HBsAg) or carriers of the Hepatitis C or HIV virus
* A body temperature above 37.5 °C
Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients

To determine whether Spatially Distributed Sequential Functional Electrical Stimulation is more effective than Standard Electrical Stimulation During Functional Electrical Stimulation in Upper Motor Neuron Patients

Design: SCED (single case experimental design) prospective, monocentric, comparative interventional study (SDSS versus SES) Population: patients with motor deficit due to upper motor neuron syndrome Setting: Neurologic Rehabilitation Unit Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling.

Participants will be evaluated before and during the training.

Eligibility Criteria:
Inclusion Criteria:

Patients with Upper Motor Neuron syndrome:

* adult (\> 18 years)
* motor deficit due to an acquired traumatic or neurodegenerative motor deficiency of the central nervous system (MRC\<4/5)
* stable clinical condition, particularly on the cardiovascular level (recent assessment by a cardiologist with stress test)
* non denervated muscles
* tolerant to muscle electrical stimulation
* having given written consent
* able to cycle 30 minutes with FES-cycling

Exclusion Criteria:

* major cognitive comprehension disorders that could compromise understanding of the protocol and the smooth running of the study
* cardiac pacemaker and other contraindications relating to the use of electrostimulation (in particularly "deep vein thrombosis")
* spasticity of the lower limbs making flexion/extension movement difficult
* participation in another study
* pregnancy
* people with the following legal and administrative states or situations:
* people placed under judicial protection;
* persons deprived of their liberty, persons subject to psychiatric care and persons admitted to a health or social establishment for purposes other than that of clinical investigation;
* unemancipated minors;
* people who are not affiliated to a social security scheme or beneficiaries of such a scheme
Endoscopic Grading of Intestinal Metaplasia

Long-term Helicobacter pylori infection causes premalignant gastric conditions, such as atrophic gastritis and intestinal metaplasia. Image-enhanced endoscopy techniques such as narrow-band imaging (NBI) and magnifying endoscopy improve the diagnosis of gastric intestinal metaplasia (GIM). However, there are no comparative data on the utility of NBI and magnifying endoscopy for diagnosing GIM.

This study aims to evaluate the diagnostic performance of NBI and magnifying endoscopy for GIM in a country with high risk of gastric premalignant lesions.

Eligibility Criteria:
Inclusion Criteria:

* Gastroscopy can be performed
* Pathological analysis can be performed for analysis of gastric atrophy and intestinal metaplasia

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics
* History of H. pylori eradication
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding
Family-based Screening and Treatment of Helicobacter Pylori：A Real World Study

The habit of family meals makes the infection rate of Helicobacter pylori high in China, which is also the main cause of reinfection of Helicobacter pylori. Eating together can easily cause family members to be infected with Helicobacter pylori. We used a real-world study to understand the risk factors, epidemiological characteristics, and safety and effectiveness of eradication therapy for helicobacter pylori infection in family-based screening and treatment.

Helicobacter pylori infection is a worldwide problem, which is the main cause of gastric cancer. The habit of sharing meals in the family is one of the factors contributing to the high infection rate of HP in China, as well as the main cause of reinfection of HP. Sharing meals can easily cause family members to be infected with HP.Family members live together, eat together, share tableware and other behaviors through the "mouth to mouth" transmission of Helicobacter pylori may be infected with each other, is also one of the reasons for the eradication of many patients after re-infection.At the same time, repeated infection and treatment of Helicobacter pylori will increase the difficulty of Helicobacter pylori reeradication.As a family unit, to study the status of our country family helicobacter pylori infection, epidemiological characteristics, infection risk factor, the different schemes, such as the safety and efficacy of treatment to take measures to reduce the infection rate is of great significance to prevention and treatment of gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Community population over 3 years old who signed the informed consent.
* at least 2 people in the family.
* living together for at least 10 months each year in the past 5 years except child aged below 5.

Exclusion Criteria:

* PPI drugs such as esomeprazole、pantoprazole、 rabeprazole,、lansoprazole、famotidine and H2 receptor antagonists were taken within two weeks.
* antibiotics、bismuth agents or traditional Chinese medicine with antibacterial effect were taken within four weeks
* There are other factors that researchers think are not suitable for participation
Feasibility and Impact of Resistance Training for Sarcopenic Dysphagia

The purpose of the study is to test and optimize the feasibility of an activity-based resistance training program for patients with sarcopenic dysphagia. The study is a feasibility study designed as a multiple-case study with quantitative and qualitative data sources related to a number of feasibility outcomes and clinical outcomes during and after the intervention. Participants are 15 patients\> 65 years of age are referred for dysphagia assessment by an Occupational Therapist (patients may be admitted to several different wards (endocrinology, pulmonary medicine, infectious medicine, gastrology). The intervention is offered during hospitalization and after discharge for a maximum of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Speaks and understand Danish language, and able to provide written informed consent for participation
* Dysphagia verified by a Gugging Swallowing Screen
* Generalized sarcopenia determined by a Danish version of the questionnaire SARC-F
* Sarcopenia of the swallowing mechanism indicated by reduced tongue strength measured with the Iowa Oral Performance Instrument

Exclusion Criteria:

* Dysphagia related to the esophagus
* Psychiatric diagnosis
* Neurodegenerative disease or
* Needs palliative care
* Admitted to hospital from a nursing home.
Neural Mechanisms Underlying Astigmatism

This study is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients.

The presence of astigmatism can lead to substantial reductions in visual performance in a variety of clinical vision measures and functional visual tasks. However, the neural mechanisms underlying the astigmatism remains unknown. The current study recruited three groups (patients with with-the-rule astigmatism and amblyopia, patients with with-the-rule astigmatism but without amblyopia, normal controls) of subjects and patients receive perceptual learning training (orientation discrimination task) which lasts for around 15 days. This main aim is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients.

Patients with astigmatism or amblyopia were included in this study. All participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life quality questionnaire and fundus examination.

Eligibility Criteria:
Inclusion Criteria:

* high astigmatism

Exclusion Criteria:

* other types of disease (especially optical diseases) that may affect study
Study of a Strategy to Prevent Oversedation in Intensive Care Patients Under Mechanical Ventilation

The purpose of the present study is to determine whether administration of sedation according to a strategy including a bundle of measures to prevent oversedation is associated with a reduction in mortality of intensive care unit patients requiring mechanical ventilation, compared to administration of sedation according to usual practices.

In intensive care unit (ICU) patients receiving mechanical ventilation (MV), potent hypnotics and morphinics are frequently administered to increase synchrony with the ventilator, control agitation and decrease discomfort and pain due to the tracheal tube, bed ridding, painful condition and diagnostic or therapeutic procedures.

However, administration sedatives or morphinics is often excessive and may result in deep and prolonged alteration of consciousness, delayed weaning from MV and prolonged MV. and exposes the patient to a higher risk of ventilator-associated pneumonia, ICU delirium and neuromuscular weakness at awakening.

The present randomized multicenter study will compare the day-90 mortality of a group of patients receiving conventional sedation to the mortality of a group of patients receiving sedation administered according to an algorithm aimed to prevent oversedation to the mortality. The algorithm is built on a graduate therapeutic response to increasingly intense symptoms of discomfort, pain, ventilator dyssynchrony and agitation, and includes the use of analgesics, non hypnotic benzodiazepines, neuroleptics, repeated intravenous (IV) boluses of hypnotics and short duration (6 hours) IV hypnotic infusions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Admission to ICU with expected mechanical ventilation duration \> 48 hrs
* Mechanical ventilation in ICU for less than 12 hours
* Information provided to the patient or proxy

Exclusion Criteria:

* ICU Admission after cardiac arrest
* Acute or chronic neuromuscular disease
* Tracheotomy on ICU admission
* Acute cerebral injury with intracranial hypertension requiring continuous IV sedation with or without neuromuscular blockade
* Status epilepticus
* Treatment withdrawal decision
* Pregnancy, breast feeding
* Concurrent participation in another interventional study requiring a change in usual practice of sedation or mechanical ventilation
Effects of a Dietary Fiber on Fecal Microbiota and Metabolism

The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one period, and 30 g per day in the other. In another three-week period, they will consume the same foods, but with no fiber added. Major outcomes will include fermentability of the fiber, as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The caloric value of the fiber will be determined and metabolic measures related to blood glucose control and inflammation will also be taken.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index from 25 to 35 kg/m2.
* Willing to consume study foods and comply with dietary exclusions and specimen collection

Exclusion Criteria:

* Pregnancy
* Diabetes
* Gastrointestinal disease
* Regular use of pre- or probiotics
* Recent use of antibiotics
* High intake of dietary fiber
Effectiveness of AutoHYpnosis in the Prevention of Anxiety During Radiotherapy of Head and Neck Tumors (HYMACO)

HYMACO is a monocentric, randomized comparative pilot study with a total duration of 25 months. The purpose of this study is to evaluate the effectiveness of autoHYpnosis by anchoring in the prevention of anxiety related to wearing the mask for radiotherapy of head and neck tumors.

60 patients will be randomized into 3 arms ARM A : Standard care ARM B : Autohypnosis ARM C : Musicotherapy This study is carried out during the first 5 radiotherapy sessions because this is decisive for the good progress of subsequent sessions


Eligibility Criteria:
Inclusion Criteria:

* Age \> or =18
* Patient to receive radiotherapy for a tumor of the head and neck, with a compression mask
* Patient who obtained a score equal to or greater than 56 on the STAI form Y-A questionnaire during the consultation with the radiotherapist before starting treatment
* Patient capable and willing to follow all study procedures in accordance with the protocol
* Patient who understood the study and gave informed consent
* Patient affiliated to a social security system

Exclusion Criteria:

* Contraindication to hypnosis: psychosis, schizophrenia
* Non-French speaking patient
* Significant hearing loss
* Pregnant woman, likely to be, or breastfeeding
* Persons deprived of their liberty or under guardianship (including guardianship)
* Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons
* Patient who has already received radiotherapy to the head or neck with a compression mask
Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant.


Eligibility Criteria:
Inclusion Criteria:

* Primary liver transplant recipients.
* Transplanted liver functioning at an acceptable level by 24 h post-transplant
* Patients started on tacrolimus therapy within 12 h post-transplant

Exclusion Criteria:

* Previous transplantation or multiple organs transplantation
* Acute rejection
* Non-heart beating donor

Other protocol-defined inclusion/exclusion criteria may apply.
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism

The goal of this randomized controlled trial is to compare letrozole alone versus letrozole plus levothyroxine for ovulation induction in infertile women with both PCOS and subclinical hypothyroidism. The main questions it aims to answer are:

Is letrozole plus levothyroxine superior to letrozole alone in achieving ovulation in these patients? Does combining levothyroxine with letrozole lead to higher pregnancy and live birth rates compared to letrozole alone?

Participants will be randomized into two groups:

Group 1 will receive letrozole only, starting at 2.5 mg daily from day 3 to 7 of the menstrual cycle. The dose will be increased up to 7.5 mg if no ovulation occurs, for a maximum treatment period of 6 months or until pregnancy is achieved.

Group 2 will receive letrozole at the same doses as group 1 plus 25 mcg levothyroxine daily.


Eligibility Criteria:
Inclusion Criteria:

Age between 20-40 years

BMI between 18-35 kg/m2

Meet diagnostic criteria for PCOS based on the Rotterdam consensus criteria and ESHRE/ASRM modifications (2018):

Oligo- and/or anovulation Clinical and/or biochemical signs of hyperandrogenism Polycystic ovaries on ultrasound

Subclinical hypothyroidism defined as TSH level between 5-10 mIU/L with normal free T4

Infertility duration ≥ 1 year

Intact ovaries and uterus, confirmed by physical exam and imaging

Normal semen analysis in male partner

No tubal or peritoneal factor contributing to infertility

Effective contraception if not attempting conception

Willing and able to provide informed consent

Exclusion Criteria:

Known thyroid disease or on thyroid medications

Abnormal thyroid function tests other than subclinical hypothyroidism

Hyperprolactinemia

Presence of other causes of infertility such as:

Moderate to severe male factor infertility Bilateral tubal occlusion or peritoneal factors Stage III-IV endometriosis Ovarian failure or insufficiency (high FSH or low AMH)

Previous diagnosis of any type of congenital adrenal hyperplasia

Uncontrolled diabetes (HbA1C \>8%)

History of deep vein thrombosis or thromboembolic events

Any contraindication to letrozole or levothyroxine

Previous use of letrozole or levothyroxine in past 6 months

Current or suspected pregnancy

Breastfeeding

Inability to comply with treatment and follow-up procedures
Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain

One hundred and twenty patients at age range from 18 to 60 undergoing laparotomy was enrolled in this study. Patients were randomly assigned to two groups 60 in epidural group and the other 60 patients in rectus catheter group. epidural catheter inserted pre induction but rectus sheath catheter inserted by the surgeon at the end of surgery.

One hundred and twenty patients at age range from 18 to 60 undergoing laparotomy was enrolled in this study. Patients were randomly assigned to two groups 60 in epidural group and the other 60 patients in rectus catheter group. epidural catheter inserted pre induction but rectus sheath catheter inserted by the surgeon at the end of surgery. In both groups we activated with10 ml bupivacain25% before patient recovery then 10 ml bupivacain.125% each 6 hours. If patient still in pain 1gm perflgan injected. If patient still in pain 10 mg nalufine for 70 kg patient injected. we will record pulse, blood pressure and visual analogue scale at 0,6,12,24 and 36 hours postoperative. Also Occurrence of nausea and vomiting, Time of return of bowel movement, Time of discharage and amount of analgesia used will be recorded. Results, discution will be later.

Eligibility Criteria:
Inclusion Criteria:

* patients at age rang from 18 to 60 undergoing laparotomy
* patients ASA1,2 physical status

Exclusion Criteria:

* any known coagulopathy
* morbid obesity
* kyphosis or scoliosis
* those with known sensitivity to local anesthetic drugs
* lack of cooperation and inability to understand or perform verbal or physical assessments.
Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which means it affects the brain. This study will evaluate how ABBV-951 is absorbed under the skin of participants with PD when administered to arm, thigh and flank compared to the abdomen.

ABBV-951 is an investigational drug being developed for the treatment of PD. Study doctors randomly assign participants to 1 of 4 groups, called treatment arms. Each treatment arm receives ABBV-951 administered in a different order in the arm, high, flank and abdomen. Approximately 12 adult participants over 30 years with a diagnosis of PD will be enrolled in approximately 10 sites in the United States.

Participants will receive continuous (24hours/day) subcutaneous infusion of ABBV-951 for 2 consecutive days for each infusion site (arm, thigh, flank and abdomen), for a total duration of treatment up to 12 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will be confined at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Adverse events will be monitored throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease (PD) that is Levodopa-responsive.
* Must be taking a minimum of 400 mg/day of levodopa equivalents (LE) and be judged by the investigator to have motor symptoms inadequately controlled by current therapy.
* Must have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum daily average of 2.5 hours of "Off" time (with a minimum of 2 hours of "Off" time each day).

Exclusion Criteria:

- History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.