cyrilzakka/clinical-trials huggingface dataset:
Carperitide in Acute Respiratory Distress Syndrome (ARDS)

The purpose of this study is to determine whether Carperitide is safe and effective in the management of Acute Respiratory Distress Syndrome (ARDS).

Acute respiratory distress syndrome (ARDS is a severe form of acute lung injury. ARDS is characterized by an increase in pulmonary vascular permeability resulting from a non-cardiogenic cause, leading to an increased vascular water volume, pulmonary inflammation, and severe hypoxemia. Conventional therapy for ARDS is primarily respiratory management by mechanical ventilation using positive end-expiratory pressure (PEEP). Mechanical ventilation is the major management concern in patients with ARDS, due to its higher risk of infections and morbidity. Treatment with Carperitide may reduce time on the ventilator by reducing pulmonary edema and by improving gas exchange. The results of Carperitide studies in animals and humans support the idea that the hormone will be effective in managing the acute pulmonary complications and hypoxemia seen in ARDS.

Eligibility Criteria:
Inclusion:

In order to participate in the study, patients must:

* be 18 years or older
* have an acceptable PF ratio
* have adequate fluid volume
* be intubated less than 7 days

Exclusion:

In order to participate in the study, patients must not meet any of the following criteria:

* be moribund
* be immunocompromised
* have pneumonia (caused by Pneumocystis carinii)
* have recieved another investigational drug or device within the last 30 days
* have a Do not Resuscitate order
Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma

Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma.

The primary objective is to assess the percentage of patients alive without prograssion at 8 months.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the small intestine (duodenum, jejunum, ileum)
* Metastatic or locally advanced unresectable tumour with curative intent
* Patient who never received first-line chemotherapy
* Measurable lesion according to RECIST 1.1 criteria
* ECOG status \< or = 2 for patients under 70 years, or 0 or 1 for patients over 70 years
* Life expectancy estimated at over 3 months
* Patient over 18 years of age
* Patient able to understand and sign the information and informed consent note
* Women of childbearing age and men who have sex with women of childbearing age must agree to use contraception during the trial treatment and for at least 9 months after stopping the experimental treatments.

Exclusion Criteria:

* MSI/dMMR tumor
* Adenocarcinoma of the ampulla of Vater
* Neutrophils \< 1500/mm3, platelets \< 100 000/mm3
* Hemoglobin \< 9 g/dL, total bilirubin \> 1.5x normal, alkaline phosphatase \> 2.5x normal (or \>5x normal if liver metastases), creatinine clearance \> or = 40 ml/min. according to MDRD
* Hypokalaemia, hypomagnesaemia and hypocalcaemia below normal, and for calcaemia, it must be corrected before enrolment.
* Adjuvant chemotherapy completed less than 6 months ago
* History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure
* Severe renal failure
* Peripheral sensory neuropathy with functional discomfort
* Active and/or potentially severe infection or other uncontrolled conditions
* Treatment with a cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment (refer to paragraph 8.3 "Contraindicated treatments" of the protocol)
* Patients currently undergoing treatment using St John's Wort
* Treatment with brivudine within 4 weeks prior to the administration of protocol
Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy

The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children and adolescents with drug-resistant epilepsy regarding seizure control, and to create a protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.

The study is a prospective trial on the Modified Atkins Diet for children and adolescents with drug-resistant epilepsy. The Modified Atkins Diet is a less restrictive diet than the classical ketogenic diet, which is usually offered to this group of patients. Twenty patients between 2 and 18 years are included in the study, and the study period is 6 months. The study will be conducted at the National Centre for Child Epilepsy in Norway.

Eligibility Criteria:
Inclusion Criteria:

* age: 2-18 years
* At least 3 epileptic seizures per week
* Tried at least two anti-epileptic drugs without satisfactory seizure control
* Willing to try diet treatment for 6 months

Exclusion Criteria:

* Too difficult for the family to adhere to a strict diet
* Not able to fill in a seizure calendar
* Local authorities will not approve the treatment
* VNS stimulator the last 12 months or changes made to VNS stimulator during the last three months
* Other disease where a diet high in fat is contra indicated
* Diet treatment is not possible because of poor intake of food or fluids
* Cortisol or other medication that influence energy metabolism or epileptic drug metabolism last month
* Patient has the last month used alternative medicine which may influence the diet
* Patient has tried the ketogenic fiet og Modified Atkins diet the last three years
* pregnancy
Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

This study will compare the outcome of endodontic treatment using conservative or traditional access design in permanent molars with clinical signs indicative of irreversible pulpitis

After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be obtained after explaining the procedure and its associated risks and benefits.

Clinical diagnosis of symptomatic irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing.

Once included, study subjects will be randomly allocated to either traditional access or conservative access group. Subsequently biomechanical preparation will be carried out using standard protocol with the use of rotary NiTi file system followed by root canal filling using gutta percha and zinc oxide eugenol sealer. Teeth will be restored using composite resin in the same appointment.

Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at 6 and 12 months from baseline.

Eligibility Criteria:
Inclusion Criteria:

* The patient should be ≥18 years of age.
* Restorable mandibular molars with extremely deep caries involving occlusal surface only
* Clinical diagnosis of symptomatic irreversible pulpitis with PAI score ≤2.
* Tooth should give positive response to pulp sensibility testing.
* Tooth with probing pocket depth and mobility are within normal limits.
* Non-contributory medical history.

Exclusion Criteria:

* Teeth with immature roots.
* No pulp exposure even after caries excavation.
* Teeth with signs of pulpal necrosis including sinus tract or swelling.
* Teeth with percussion sensitivity
* Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
* Had taken analgesic in past 3 days
* Teeth with pathologic changes such as internal or external resorption
* Teeth with morphological variation
* Teeth with root canal calcification
* Teeth with fixed full coverage prosthesis
Ultrasound Guidance for Embryo Transfer

Randomized controlled study comparing the TVUS versus TAUS guidance during the procedure of embryo transfer.

The aim of this study was to Compare between transvaginal and transabdominal ultrasound guided embryo transfer as regarding clinical pregnancy rate, patient comfort, time required for embryo transfer and endometrial visualization at time of embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing autologous ICSI and frozen embryo transfer (FET) cycles.

Exclusion Criteria:

1. Cases of sever ovarian hyperstimulation requiring embryo cryopreservation
2. Gestational surrogate cycles
3. Oocyte donation cycles
4. Very poor responders
5. Patients with inadequate visualization of the uterus by ultrasound.
6. Very difficult mock embryo transfer.
TARGET BP I Clinical Trial

The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

The TARGET BP I clinical trial uses a percutaneous catheter to deliver very small amounts of alcohol (neurolytic agent). The patient population for this trial is comparable to those used in other renal denervation studies, but also incorporates lessons learned from recent trials of renal denervation. This is to enable the study of an optimized patient population who stands to benefit from the intervention, in a manner that reduces possible study bias.

This trial is intended to evaluate the safety and efficacy of the Peregrine Catheter when used to deliver a 0.6 mL volume of alcohol to the perivascular area of the respective renal arteries while patients are adequately managed with oral antihypertensive medications.

Eligibility Criteria:
Inclusion Criteria:

1. Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg when receiving 2 to 5 antihypertensive medications.
2. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings

Exclusion Criteria:

1. Subject has renal artery anatomy abnormalities.
2. Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
3. Subject has documented sleep apnea.
4. Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association \[NYHA\] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (\>60 mmHg pulmonary artery or right ventricular systolic pressure).
5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
6. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Effect of Therapeutic Touch on Labor Pain and Hormone Levels

This study was conducted to determine the effect of sacral region-focused therapeutic touch applied during the latent phase of labour on hormone levels, labour comfort, and perception.

A randomized sham controlled trial design was used in the study, which was conducted with 50 primiparous pregnant women. While Therapeutic Touch (25) focused on sacral region was applied in the intervention group, Sham Therapeutic Touch (25) was applied in the control group. Data were collected using a Personal Information Form, the Visual Analogue Scale, a Hormone Values Follow-up Form, the Childbirth Comfort Questionnaire and the Perception of Birth Scale.

Keywords: Labor Pain,Therapeutic Touch, Childbirth, Hormones

Aim: This study was conducted to determine the effect of sacral region-focused therapeutic touch applied during the latent phase of labour on hormone levels, labour comfort, and perception.

Method: This randomised sham controlled experimental trial was conducted with two groups (intervention and control groups) in a state hospital between 08 March 2022 and 01 April 2023. The sample size of the study was calculated using the G\*power 3.1.9.6 programme. As a result of the calculation, twenty-five pregnant women for each group were included in the study. While Therapeutic Touch (TT) focused on sacral region was applied in the intervention group, Sham Therapeutic Touch (STT) was applied in the control group. Data were collected using a Personal Information Form, the Visual Analogue Scale (VAS), a Hormone Values Follow-up Form, the Childbirth Comfort Questionnaire (CCQ) and the Perception of Birth Scale (PBS). IBM SPSS V25 programme was used for statistical analysis of the study. The statistical significance was assessed at the level of p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Being primipara,
* Having a gestational age of 38-42 weeks,
* Planning to have a normal vaginal delivery,
* Having a 3-4 cm dilation in the latent phase,
* Having a single fetus and head presentation,
* Speaking and communicating in Turkish,
* Agreeing to participate in the study,
* Having no high-risk pregnancy.

Exclusion Criteria:

* Receiving induction,
* Receiving labor analgesia/anesthesia,
* Having sensitivity or problems with touch,
* Having to leave during the intervention due to some reasons such as medical procedures, etc.
Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy

The suspension technique is reported as the puboprostatic ligaments that attach the prostate to the symphysis pubis. After the ligating the complex, including both the dorsal vein complex and the puboprostatic ligaments, this complex was sharply divided anteriorly from the prostate with a safe distance (1-2 mm), and the urethra is defined and divided. After removing the prostate, the ileal pouch is reconstructed by completely everting the mucosa and sutured outward with a running 4-0 absorbable suture around the edge. The neck of the neobladder was narrowed to ≈1 cm, for convenient passage of a 20 F catheter. Anastomotic sutures of 3-0 absorbable polyglactin were placed at the 1, 3, 5, 6, 7, 9, 11 and 12 o'clock positions

The suspension technique is reported as the puboprostatic ligaments that attach the prostate to the symphysis pubis. After the ligating the complex, including both the dorsal vein complex and the puboprostatic ligaments, this complex was sharply divided anteriorly from the prostate with a safe distance (1-2 mm), and the urethra is defined and divided. After removing the prostate, the ileal pouch is reconstructed by completely everting the mucosa and sutured outward with a running 4-0 absorbable suture around the edge. The neck of the neobladder was narrowed to ≈1 cm, for convenient passage of a 20 F catheter. Anastomotic sutures of 3-0 absorbable polyglactin were placed at the 1, 3, 5, 6, 7, 9, 11 and 12 o'clock positions through the full thickness of the urethra, including the mucosa and muscularis of the neobladder neck, ensuring mucosa-to-mucosa anastomosis. The sutures at the 1 and 11 o'clock positions were anchored to the ligated complex including both the dorsal vein complex and the puboprostatic ligaments, to suspend the poucho-urethral anastomosis (suspension technique). The difference between the suspension and no-suspension techniques is only the placing of two sutures into the ligated complex

Eligibility Criteria:
Inclusion Criteria:

* Patient age \>18 years.
* Muscle-invasive bladder carcinoma (MIBC).
* Non-muscle-invasive bladder carcinoma (NMIBC) fulfilling the following criteria:

  1. - (recurrent disease that is unresponsive to other treatments
  2. - high-grade tumors (T1, carcinoma in situ) refractory to intravesical therapy
  3. -Multifocal or recurrent high-grade tumors despite intravesical therapy and the tumor progression from NMIBC to MIBC).

Exclusion Criteria:

* NMIBC or benign disease.
* Severe hepatic renal dysfunction.
* Urethral involvement with bladder carcinoma.
* Poor overall health status.
* Severe renal dysfunction.
Protein Digestibility of Whey and Zein.

The evaluation of protein quality has top priority according to Food and Agricultural Organization of the United Nations. However, one aspect of protein quality, namely the digestibility of protein is largely unknown. A database on this matter is lacking as it is difficult to measure ileal digestibility in humans.

Objective: This study aims to determine the digestibility of amino acids in two protein sources in men and women with normally functioning ileostomies.

Study design: Intervention study with 6 test days, testing 3 meals each twice. Study population: Eight men and women with normally functioning ileostomies will be recruited for the study.

Intervention: On six separate test days, subjects will receive a meal, consisting of a drink and biscuit. With this, two different protein containing meals, i.e. zein and whey, and a protein-free meal is tested; these three treatments are given at two occasions, thus in total 6 meals are tested. After consumption of the meal, subjects collect their digesta for nine hours.

Main study parameters/endpoints: Ileal amino acid digestibility of zein and whey protein isolate.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The subject will not benefit from the study except for the contribution to scientific research. The risk of participating to this study is low, some gastrointestinal discomfort could occur. Subjects have to come to the research facility seven times, a screening visit of 1 hour, and 6 experimental days of 10 hours. Subjects will be financially compensated for participation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age between 18 and 60
* Willing to eat animal protein
* Have a well-established and normally functioning terminal ileostomy, with stomal faeces of normal physiological consistency
* Good general health, meaning subjects should be well-recovered from the ileostomy operation, their underlying disease should be cured or in remission and they should not have any other major health problems

Exclusion Criteria:

* Taken antibiotics or medication that majorly impair small intestinal digestion and absorption within eight weeks of participating in the study.
* Have been pregnant or breastfeeding in the last 12 months, or plan to become pregnant during the study
* Having renal impairment, coeliac disease or diabetes
* Drug abuse
* Alcohol consumption of \>14 units per week.
* Having an allergy or intolerance to dairy, corn products or fructose
* Currently taking protein supplements and would not be willing to stop using these during the study
* Being on a controlled diet or dietary weight loss regimen during the two weeks prior to the start of this study and/or during the study
* Personnel of division of Human Nutrition, Wageningen University..
* Current participation in other research from the Division of Human Nutrition
* Not having a general practitioner
A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)

The primary objective of this study was to examine the effect of levodopa-carbidopa intestinal gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with advanced Parkinson's disease (PD).

This was a Phase 3b, open-label, randomized, multicenter, 12-week study. The study consisted of 3 sequential periods: Screening, Treatment, and Follow-Up. The OMT group had the same schedule of visits/procedures throughout the study as the LCIG treatment group, except for visits related to nasojejunal (NJ)/percutaneous endoscopic gastrostomy (PEG) procedures, titration of LCIG, and follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of idiopathic Parkinson's disease (PD) according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
* Participants with advanced levodopa-responsive PD and persistent motor fluctuations who have not been controlled with optimized medical treatment (OMT: the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected with regard to any additional manipulations of levodopa and/or other antiparkinsonian medication based on the Investigator's clinical judgment)
* Unified Dyskinesia Rating Scale (UDysRs) Total score ≥ 30 at Visit 3

Exclusion Criteria:

* Participant(s) treated with levodopa-carbidopa intestinal gel (LCIG) previously
* Participant's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g. caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g. Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD
* Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.
* Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma)
* Participant(s) experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g. pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation as judged by the Principal Investigator
Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia

Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe, unusual headaches associated with multifocal segmental vasoconstriction of the intracerebral arteries. In addition to headache, focal neurological deficit and/or seizures are quite frequently described, but anterograde amnesia seems to but extremely rare. Indeed, to date, only one case of RCVS associated with transient global amnesia (TGA) has been published. In case of an atypical presentation of TG, associated with brutal headaches, it is important not to ignore an assocation with RCVS because management, treatment, evolution and prognosis are different. Indeed, TGA is a monophasic phenomenon of less than 24 hours duration, without associated complications, which does not require any particular treatment. On the other hand, RCVS, although most often of excellent prognosis, can have severe complications such as intracerebral hemorrhage, subarachnoid hemorrhage, posterior reversible encephalopathy syndrome and cerebral infarction. In order to limit headaches and potential complications, RCVS require special management, including symptomatic treatments for headaches, complete rest, removal of precipitin factors and introduction of calcium channel blockers for a few weeks.

This study aim to described three cases of patient who presented with concomitant TGA and RCVS, and to discuss pathogenic mechanism which may be similar in both these pathologies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a proven or probable RCVS concomitant with certain transient global amnesia

Exclusion Criteria:

* Not proven transient global amnesia, not proven or possible RCVS