cyrilzakka/clinical-trials huggingface dataset:
A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.
* Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.
* Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.
* Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.
* Cohort 3: Are BRCA positive and have previously received a PARP.
* Cohort 4: Have primary platinum refractory disease.
* Have adequate organ function.
* Must be able and willing to undergo mandatory tumor biopsy.

Exclusion Criteria:

* Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.
* Have known central nervous system malignancy or metastasis.
* Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.
* Have at least one of the following:

  * history of abdominal fistula or gastrointestinal perforation
  * intra-abdominal abscess within last 3 months prior to the first dose of study drug
  * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug
* Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).
* Have a serious cardiac condition.
* Have a history of prior radiotherapy to the whole pelvis.
* Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.
* Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.
Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient

Severe brain injuries lead to disorders of consciousness after coma. During this awakening period, detection of arousal is critical to the adaptation of medical strategy, but global paralysis, including facial expression, make the clinical assessment very difficult. Emotional facial expressions are a significant part of this clinical assessment. They are both a landmark of the internal state of the patient (comfort versus discomfort) and a landmark of the relational level with his environment. Visible emotional facial expression is a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely noticeable and very brief. These micro expressions are usually produced when one tried to voluntary hide emotional expressions. In this study, we hypothesize that some patients awakening from coma could still produce microexpression before being able to produce visible emotional facial expressions. This ability to produce micro-expression could be an early landmark of relational awakening in severe brain lesions.


Eligibility Criteria:
Inclusion Criteria:

* Brain-damaged patient (stroke, traumatic brain injury, anoxia)
* Disorder of consciousness (CRS-R≤ 10) more than 48h after stopping sedation
* Patient without spontaneous or stimulated facial expressions

Exclusion Criteria:

* Medically unstable patient
Comparison of Central Versus Peripheral Placement of Local Anesthetic

Does ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.

A comparison of the infraclavicular placement of local anesthetic either centrally (posterior cord) vs peripheral placement (lateral or medial cord) using ultrasound guidance. This will be done to determine if ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class I-III.
* Patient is undergoing elective hand or forearm surgery.
* Patient is an adult, 18 years old or older.

Exclusion Criteria:

* Morbid obesity (calculated body mass index \> 35 kg/m2).
* Patient unable to cooperate.
* Patient with a known brachial plexus injury.
* Medical contraindication to anesthetic technique (allergy, cardiac condition, neurologic condition, localized infection, bleeding disorder).
* Patients who are pregnant.
Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)

This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a male or female 12 years of age or older.
* Have a documented history of SAR resulting from exposure to Mountain Cedar pollen for a minimum of 2 years immediately preceding Screening Visit 1.
* Have demonstrated sensitivity to Mountain Cedar pollen through a standard skin prick test.
* Have a minimum rTNSS of at least 6 units for the morning (AM) assessment on the day of Visit 2 and Visit 3.
* Have a minimum average rTNSS score of at least 6 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
* Have a minimum stuffy nose score of at least 2 units on the day of Visit 3.
* Have a minimum average stuffy nose score of at least 2 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
* Have at least one score ≥ 2 units at Visit 3 of any of the RQLQ(S) questions #4-#6 regarding sleep.

Exclusion Criteria:

* Have a nasal condition which, in the opinion of the Investigator, interferes with successful nasal drug administration or absorption (in either nostril) within the last 60 days prior to Screening Visit 2.
* Have asthma requiring medication other than intermittent use of an inhaled short-acting β-agonist.
* Is participating or have participated in any investigational drug or device study within 30 days preceding Visit 2.
* Have had nasal or sinus surgery within 12 weeks of Visit 2.
* Have a known sensitivity to bepotastine besilate or any excipient component of the investigational product (IP).
* For female subjects 12 years of age or older (other than those who have been menopausal for at least 24 months or those who are surgically sterile), are pregnant, planning to become pregnant, or nursing/lactating, or refuses to abide by the contraception stipulations in the inclusion criteria.
Behavioral and Neural Characteristics of Adaptive Speech Motor Control

This study meets the NIH definition of a clinical trial, but is not a treatment study. Instead, the goal of this study is to investigate how hearing ourselves speak affects the planning and execution of speech movements. The study investigates this topic in both typical speakers and in patients with Deep Brain Stimulation (DBS) implants. The main questions it aims to answer are:

* Does the way we hear our own speech while talking affect future speech movements?
* Can the speech of DBS patients reveal which brain areas are involved in adjusting speech movements? Participants will read words, sentences, or series of random syllables from a computer monitor while their speech is being recorded. For some participants, an electrode cap is also used to record brain activity during these tasks. And for DBS patients, the tasks will be performed with the stimulator ON and with the stimulator OFF.


Eligibility Criteria:
General inclusion criteria:

* native speaker of American English
* no communication or neurological problems (except for subjects in the DBS group)
* 250-4000 Hz pure tone hearing thresholds equal to or better than 25 dB HL for children and young adults and equal to or better than 35 dB HL for older adults
* no medications that affect sensorimotor functioning (except for in the DBS group)
* adult subjects: 18 years of age or older
* typical children: 4;0 to 6;11 \[years;months\] or 10;0 to 12;11 \[years;months\])

Specific inclusion criteria for children:

\* scoring above the 20th percentile on the Peabody Picture Vocabulary Test (PPVT-5), Expressive Vocabulary Test (EVT-3), Goldman-Fristoe Test of Articulation (GFTA-3), and either Test of Early Language Development (TELD-4) or (for children age 8 or older) Clinical Evaluation of Language Fundamentals (CELF-5).

Specific inclusion criteria for DBS patients:

\* bilateral electrodes implanted in either the ventral intermediate nucleus of the thalamus (Vim; a target site for patients with essential tremor) or subthalamic nucleus (STN; a target site for patients with Parkinson's disease)
RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION

Endoscopic retrograde cholangio pancreatography procedure will performed as per local standard procedure.After common bile duct cannulation,cholangiography will be performed (to confirm the stricture) followed by biliary sphincterotomy. All biliary strictures(Bismuth Type I/II/III/IV) will be enrolled for the study.

Patient opting for Uncovered self expandable metallic stent / Plastic stent will undergo biliary stent placement and considered under control arm Patient opting for radio frequency ablation + Uncovered SEMS/Plastic stent will undergo radio frequency ablation and biliary stent placement and considered under Study arm The RFA probe will be inserted into the bile duct alongwith the guidewire. Keeping the electrode overlapping the stricture, RFA will be performed using a power of 10W for 120 seconds. The electrode will be kept at the ablation site for an additional 1 minute to allow the RFA probe to cool before removal to prevent thermal injury of normal tissue and/or endoscope accessory channel. If the stricture is more than 3 cm, step-by-step RFA will be performed from the superior to inferior aspect. After RFA application, an uncovered SEMS/Plastic stent will be placed.

Placement of self expandable metallic stent is the standard of care in the palliative management of patients with malignant biliary strictures . Relieves biliary obstruction and jaundice.

Self expandable metallic stent provide efficient drainage and have superior patency rates compared with the plastic stents Endoscopic radio frequency ablation combined with stent placement can significantly prolong survival and the stent patency period without increasing the incidence of adverse events in patients with extra hepatic cholangiocarcinoma patient.

Compared to plastic/ metal stent placement alone the addition of radio frequency ablation to stent placement would have better outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years
2. Malignant biliary obstruction confirmed using computed tomography (CT) or abdominal magnetic resonance imaging(MRI), with pathological confirmation whenever possible;
3. Clinical jaundice, a serum bilirubin level greater than 5 mg/dL, and/or cholangitis;
4. ECOG performance status score≤2
5. Un resectability or refusal to be surgically treated.
6. Eligible patients were those with biliary obstruction due to cancer of the gallbladder, or bile ducts; who were considered unsuitable for surgery because of distant metastases, vascular invasion, or severe disability due to age or associated diseases.
7. Non-resectability was established through the consensus opinion of a multidisciplinary tumor board.
8. Written informed consent signed by the patient.

Exclusion Criteria:
Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection

This is a multicentre, observational, epidemiological study in which infants within the first 3 months of life with UTI and children aged ≥4 months with r-UTI will be recruited from nephrology /emergency departments and primary care in European countries

This is an international, multicenter, observational, cross-sectional epidemiological study.

Study participants will undergo a screening phase and will be checked for study eligible and inclusion/exclusion criteria at study entry. No other visits will be conducted other than the first evaluation. The study will be conducted across up to 26 participating sites in Europe, including nephrology departments, paediatric emergency departments and primary care centers. Specifically, sites located more in Western and Eastern Europe will be involved in the study. In total, 600 participants with rUTI (UTI) will be included in this study, with approximately 200 participants for each age group (from 0 months to \< 3 years of age; from ≥ 3 to \< 12 years of age, from ≥ 12 to \< 18 years of age).

Eligibility Criteria:
Inclusion Criteria:

* Age between 0 weeks and 17 years
* Significant urine culture positive only for E. coli
* For infants up to 3 months of age, a confirmed first UTI episode as identified by urine culture obtained by a sterile method (as described above) and positive for E. coli only (no other pathogens)
* For children ≥4 months to \< 18 years a confirmed rUTI episode as identified by urine culture obtained by a sterile method (as described above) and positive for E. coli only (no other pathogens)
* Collection of urine culture with a sterile method (suprapubic aspiration, bladder catheterization, clean voided urine)
* Signed informed consent form (signed by participant's legally authorized representative for participants who have not attained the age of majority)
* Signed Assent Form when appropriate, as determined by participant's age and individual site and country standards

Exclusion Criteria:

* Patients ≥18 years
* Children ≥ 4 months of age with a first UTI episode
* Absence of microbiological confirmation of UTI
* UTI caused by bacteria other than E. coli or polymicrobial culture
* Urine collected with a non-sterile method (urinary bag)
* UTI episode within 30 days of the end of antibiotic treatment for the previous UTI episode
* Second urine positive for E. coli during the same episode
* Patients in the active phase of anticancer treatment
Effects of Walking Training on Different Surfaces on Walking Ability in Ambulatory Patients With Spinal Cord Injury

The study compares effects of 4-week walking training program on a walking track with difference surface \[WTDS\] and a firm ground on functional ability of ambulatory individuals with incomplete spinal cord injury \[iSCI\], using within- and between-group comparisons.


Eligibility Criteria:
Inclusion Criteria:

1. Age at least 18 years
2. Having an incomplete SCI (the American Spinal Cord Injury Association (ASIA) Impairment Scale or AIS C or D) (Kirshblum et al., 2011)
3. At a sub-acute or chronic stage of injury (post injury time: PIT \> 3 months) (Wirth et al., 2008; Blackwell et al., 2001)
4. Able to walk with or without a walking device for at least 10m (Behrman et al., 2005; Lam et al., 2008; Jackson et al., 2008)
5. Having a body mass index (BMI) between 18.5-29.9 kg/m2 (Woo et al., 2007)

Exclusion Criteria:

1. Having an SCI from a progressive disease such as multiple sclerosis or malignancy
2. Having other medical conditions that might affect ambulatory ability, such as pain in the musculoskeletal system with an intensity of pain more than 5 out of 10 on a numeric rating pain scale (Dijkers, 2010), deformities of the spine and lower extremities (i.e. scoliosis, kyphosis, and equinovarus) and other neurological or other medical disorders (thromboembolism, autonomic dysreflexia).
3. Severe spasticity of the lower extremities (Modified Ashworth Scale (MAS) more than 2) (Bohannon \& Smith, 1987; Scivoletto et al., 2008).
Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.

Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. With an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. However, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.

Eligibility Criteria:
Inclusion Criteria:

1. histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
2. age between 20 and 80 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
5. scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese
6. written informed consent
7. without preoperative chemotherapy and radiotherapy

Exclusion Criteria:

1. clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
2. history of chemotherapy, radiotherapy, immunotherapy or target therapy
3. perigastric lymphnode≥3cm
4. received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
5. multiple primary tumors
6. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
7. patients need emergency operation with complication of gastric cancer
8. adhesion due to the previous intraabdominal surgery
9. need for combined organ resection due to aggression of gastric cancer of other disease,
10. vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)
11. currently participating or participated in other clinical trials in the last 6 months
Gcsf Injection in Women With Repeated Implantaiton Failure

The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. In addition, following the injection, the level of G-CSF in the bloodstream will be verified.

Recently, scientists have been interested in G-CSF (Granulocyte - Colony Stimulating Factor) and the latter has seen its use grow in reproductive pathology.

G -CSF, a true center pivot, would act concurrently on oocyte quality and endometrial receptivity, improving:

* Immune tolerance
* The self-healing of oocyte chromosome abnormalities
* The adherence of the embryo

The injection of G-CSF molecule has been used in different circumstances. One of its uses, among others, is to help rebuild the immune system in patients undergoing chemotherapy. Some studies have been conducted in patients having embryo implantation problems; they have demonstrated improved rates of pregnancy and childbirth after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 37
* Indication of the Antagonist IVF protocol or indication of a substituted frozen embryo transfer
* Subjects with repetitive embryo implantation failure meaning: a history of 3 embryos transferred including frozen embryo without a positive pregnancy test for women 35 years and younger
* Subjects with repetitive embryo implantation failure meaning: a history of 4 embryos transferred including frozen embryo without a positive pregnancy test for women between the ages of 35 and 37.
* Negative repetitive implantation failure work up

Exclusion Criteria:

* Renal failure or cardiac failure
* Chronic neutropenia
* Past or present cancer history
* Sickle cell anemia
* Lithium treatment
* Voluntary withdrawal from the study
* Use of concomitant medication: DHEA (dehydroepiandrosterone ), CoQ10 (coenzyme Q10), Growth Hormone and Viagra
Topical YR001 Ointment in Adult with Mild to Moderate Atopic Dermatitis

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained from the subject.
2. Male or female subject is aged 18 or older.
3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
4. An Investigator Static Global Assessment (ISGA) score of 2 (mild) to 3 (moderate) at screening and Baseline.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
3. Patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
4. Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response.
5. Participation in another interventional clinical trial (e.g. investigational drug, biological agent, or device) within 30 days or 5 half-lives of investigational agent (whichever is longer) before entering, or during the trial, or previous participation in this clinical trial.