cyrilzakka/clinical-trials huggingface dataset:
Phase 1 Trial of RP-3467 Alone and in Combination with Olaparib in Participants with Advanced Solid Tumors

This is a multicenter, open-label Phase 1 trial to investigate the safety, PK, and pharmacodynamics of the Polθ inhibitor RP-3467 alone or in combination with the poly-ADP ribose polymerase inhibitor (PARPi) olaparib in adults with molecularly selected advanced solid tumors.

This is a first-in-human Phase 1, multi-center, open-label, dose-escalation study to:

* Evaluate the safety profile of RP-3467 when administered orally alone and in combination with olaparib and to define the MTD or MAD for RP-3467 monotherapy and the RP2D for the combination
* Characterize the PK profile of RP-3467 alone and in combination with olaparib

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants ≥18 years of age at the time of signing the informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Participant must have one of the following that has progressed or was non-responsive to prior systemic therapy and for which no standard or available known therapeutic option exists:

  1. locally advanced or metastatic epithelial ovarian cancer (including fallopian tube or primary peritoneal), or
  2. metastatic breast cancer, or
  3. metastatic castration-resistant prostate cancer (mCRPC), or
  4. pancreatic adenocarcinoma
* Measurable disease per RECIST v1.1 (exceptions for participants with non-measurable but evaluable disease \[per RECIST and or PSA/CA-125\])
* Next generation sequencing (NGS) report demonstrating eligible tumor biomarker
* Provision of archival tumor tissue, or if adequate archival tumor tissue is not available, provision of a fresh biopsy if there is a lesion that can be safely biopsied
* Acceptable organ function at Screening
* Acceptable hematologic function at Screening
* Life expectancy ≥12 weeks after the start of the treatment according to the Investigator's judgment

Exclusion Criteria:

* History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
* Uncontrolled, symptomatic brain metastases.
* Presence of other known active invasive cancers
* History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
* Prior therapy with a Polθ inhibitor other than RP-3467
A Study of Efficacy and Safety of PHP-201 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

This is a phase 3 study to confirm the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

As a selective ROCK inhibitor, PHP-201 is designed to alleviate the side effects, which are the disadvantages of existing intraocular pressure reducing agents, while exhibiting sufficient intraocular pressure-lowering effect in glaucoma patients. This clinical trial aims to provide a new therapeutic option by evaluating the efficacy and safety of PHP-201 0.5% in patients with primary open-angle glaucoma or ocular hypertension who require intraocular pressure reduction therapy.

Eligibility Criteria:
Subject Inclusion Criteria:

1. The age of 19 years or older
2. Diagnosis of open-angle glaucoma (POAG) or ocular hypertension (OH)
3. Intraocular Pressure(IOP) ≤ 35mmHg at both eye and IOP ≥ 22mmHg at either eye
4. Shaffer's grading \> 2
5. Best-corrected visual acuity in both eye equivalent to 0.2logMar
6. Able and willing to give signed informed consent

Subject Exclusion Criteria:

1. Central corneal thickness \<500㎛ or \>600㎛
2. Medical history of following

   * Closed-angle glaucoma, pigment dispersion syndrome, pseudoexfoliation, narrow-angle glaucoma
   * Advanced glaucomatous loss; mean deviation (MD) \< -12dB
   * Moderate to severe inflammatory/infectious disease in either eye
   * Advanced retinopathy
   * Surgical or laser therapy for glaucoma treatment
3. Have confirmed the following at the screening visit

   * SBP ≥ 180mmHg or DBP ≥ 110mmHg
   * HbA1c \> 9.0%
   * CrCl \< 30mL/min
   * AST or ALT ≥ 3 X ULN
   * Unstable angina, myocardial infarction, transient ischemic attack, cerebral stroke, coronary artery bypass graft, or coronary angioplasty within 24 weeks
   * History of malignant tumor with 5 years
   * History of the causative disease that may cause secondary glaucoma, including a history of steroid administration for more than 4 weeks
4. Conditions need to wear contact lenses during the study
5. Known hypersensitivity to any component of the investigational product
6. Who has administered topical/systemic drugs that may affect the study within a certain period prior to eligibility check or are expected to need administration during the study duration

   * Prostaglandin analogues: 5 weeks
   * β-blockers: 4 weeks
   * ROCK inhibitors: 4 weeks
   * α/β-adrenergic agonists: 2 weeks
   * Muscarinic agonists: 1 week
   * Carbonic anhydrase inhibitors: 1 week
   * Systemic corticosteroids: 4 weeks
7. Pregnant or breast-feeding
8. Who disagreed with the use of the methods of proper contraception during the study duration
9. Administration or use of other investigational drugs/devices prior to the screening visit within its 5 half-lives or 30 days, whichever is longer
10. Unsuitable for participation in the study according to the judgment of the investigator
Breath Analysis to Diagnose Lung Cancer

Determination of volatile organic compounds to discriminate patients with lung cancer from healthy smokers and non-smokers healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* patients with histologically proven lung cancer

Controls:

* healthy smoker or non-smoker subjects
* without respiratory diseases excepted chronic obstructive pulmonary disease.

Exclusion Criteria:

* history of cancer other than lung cancer within 5 years before inclusion
* oral or facial malformation
* incomprehension of maneuvers for the collection
The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum

Investigators want to find the concentration of epidural ropivacaine, which can block hemodynamic changes in the onset of pneumoperitoneum in the laparoscopic gastrectomy.

According to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during Co2 insufflation. And, for this allocation of concentration of ropivacaine, the investigators use biased coin design up-and-down method.

Based on the practices, the starting concentration is 0.375 %, and the step size of concentration is 0.125%.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing laparoscopic gastrectomy that require pneumoperitoneum
* patients who has epidural catheter to manage postoperative pain control
* patients who agree to our study

Exclusion Criteria:

* patients who don't agree to our study
* BMI\<16.0 or BMI\>35
* cardiovascular disease, pulmonary disease, renal disease
* alcoholic abuser or drug abuser
* any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction
Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm

This study will test two different needles for performing a biopsy of the pancreas during endoscopic ultrasound (EUS) procedures. Patients who are asked to participate in this study have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a diagnosis can be made. The biopsy can be performed using either a 19 or 25-Gauge needle. The purpose of this study is to compare which of the two needles is better for performing biopsies of the pancreas on masses that are greater than 35mm.

Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) can be performed using the 25, 22 or 19 gauge (G) needles. Randomized trials have shown that all three needles are safe and perform equally well. However, in a retrospective study, the diagnostic sensitivity of EUS-FNA for pancreatic masses that measured more than 35mm was less compared to smaller size masses. This is because larger size tumors have more necrosis and it is difficult to identify cancer cells in them to make a diagnosis. Therefore, more biopsies must be performed in larger size tumors to establish a diagnosis. In previous studies it has been shown that the larger 19G needles procure larger and better quality tissue. Therefore, our hypothesis is that, when a larger 19G needle is used to FNA tumors more than 35mm, a diagnosis can be achieved with fewer passes.

Eligibility Criteria:
Inclusion Criteria:

All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions greater than 35 mm on computed tomography (CT) that require FNA.

Exclusion Criteria:

* Age \< 19 years
* Unable to safely undergo EUS for any reason
* Coagulopathy (INR \>1.6, Prothrombin Time \>18secs, Thrombocytopenia \<80,000 cells/ml)
* Unable to consent
* Non-English speaking patients
* Participation in any other clinical trial (excluding registries or databases)
Dry Needling Effectiveness of Patients on Break Anterior Cruciate Ligament.

We will conduct a randomized clinical trial observing forty patients divided into two groups: one group composed of twenty individuals undergoing surgery for ruptured ACL, which perform dry needling of myofascial trigger (PGM) point of the vastus muscle and then perform techniques proprioception (group a); and twenty patients not be treated with dry needling after ACL surgery, using only proprioceptive exercises to the joint (group B).

It carries out a last fifteen days ECA surgical reconstruction of the anterior cruciate ligament. Twenty individuals in a group to be subjected to a technique of physiotherapy, dry needling were included. (Group A). Another group of twenty patients treated with conservative treatment performed a stability exercises and proprioception (Group B). Forty-six patients will be examined s. None had been previously operated by joint instability and all subjects were previously subjected to a diagnostic study by nuclear magnetic resonance before surgery and the diagnosis was confirmed by additional diagnostic testing. All patients will be evaluated by a physical therapist and Myofascial Trigger Point (PGM) of the vastus muscle will be evaluated.

patients using the following variables are evaluated:

* Pain: Visual Analog Scale (VAS) was used.
* Stiffness and physical function using the WOMAC scale (The Western Ontario and McMaster Universities Arthritis Index.).
* Range of motion of the knee joint: Scale ROM.
* Muscular strength, balance and propiocepción: Star Excursion by Balance Scale Test.

Eligibility Criteria:
Inclusion Criteria:

* over eighteen and anatomically mature surgically break LCA and valued above using MRI and functional tests to confirm the rupture of the ligament.

Exclusion Criteria:

* Patients who did not reach 18 years of age and those over 55,
* postoperative complications
* cause myofascial or neuropathic pain in the lower limb, as lumba-sacral radiculopathy, neuropraxia, neurotmesis, axonotmesis or meralgia paresthetica;
* fibromyalgia.
* hypothyroidism
* iron deficiencies and patients who had a fear of needles (fear of needles).
* Lower limb differences.
A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with Dementia with Lewy Bodies (DLB).


Eligibility Criteria:
Inclusion criteria:

Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.

Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.

Exclusion criteria:

Participants with past experience of donepezil (Aricept) therapy at the same study institution.

Participants treated with donepezil in 3 months immediately before starting the observation period.

Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.

Participants with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.

Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion

Participants with severe extrapyramidal disorders (Hoehn \& Yahr staging score is ≥IV)

Participants whose systolic blood pressure is \<90 mmHg or pulse rate is \<50 beats/min.

Participants suspected to have a complication of vascular dementia based upon neurological findings.
Effect of PCO2 Gap Algorithm Application on Outcome of High Risk Surgical Patients Undergoing Major Abdominal Surgeries

1. Primary (main):

   Comparison between goal directed therapy and PCO2 gap algorithm (carbon dioxide partial pressure venous arterial gap algorithm) application on 30 days mortality and organ dysfunction post operative
2. Secondary (subsidiary):

Comparison between goal directed therapy and PCO2 gap algorithm application on number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay,

High risk surgical participants in South valley university hospitals (teaching hospitals) who will undergo major abdominal surgeries will be included in research after giving written informed consent from the participants or from the patient's legal representative. The use of obtained data will be approved by local ethics committee.

All participants will be evaluated pre operatively and pre medicated according to protocols in our hospital, base line sequential organ failure (SOFA) score will be taken. General anesthesia for all patients will be carried on according to our local standards. As part of our routine hemodynamic monitoring during major surgery, all patients will be monitored with central venous (standard three-lumen catheter) and arterial catheters placed before the beginning of surgery. The central venous line will be positioned with the tip within the superior vena cava, and correct positioning will be verified by chest radiograph.

the participants will be divided randomly onto to groups using numerical system group A PCO2 gap algorithm(carbon dioxide partial pressure venous arterial gap) will be applied intraoperative and 12 h postoperative end point PCO2 gap 2-6mm Hg(appendix 1).

Group B goal directed therapy protocol which will include targets mean arterial blood pressure ( MAP) \> 65 mmHg, central venous pressure(CVP) between 8-12 cmH2O , Haematocrite value more than 30, mixed venous oxygen saturation (Svo2) \>75% and urine output more than \>0.5 ml/kg/hr and will be applied intraoperative and 12 postoperative end point base deficit +/- 2(appendix 2 ).

All participants will be admitted to the ICU (intensive care unit) immediately after surgery .Standard postoperative monitoring will include: electrocardiograph (heart rate), invasive mean arterial pressure, pulse oxygen saturation and urine output then will be all managed according to their allocated group for 12 hours.

Outcomes in both groups will be recorded which will be number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay, 30 days organ dysfunction, assessed by using the Sequential Organ Failure Assessment (SOFA) and 30 days mortality .

Eligibility Criteria:
Inclusion Criteria:

* Clinical criteria for high-risk surgical patients used by Shoemaker and colleagues and adapted by Boyd and colleagues

Exclusion Criteria:

* patients who will refuse to continue on research patients who will not be admitted post operative in the ICU
Motor Training for Infants With Cerebral Palsy

The intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.

The aims of this study are to test the feasibility, acceptability, and operationalize a novel motor intervention, called "Let's Move" delivered using a combined clinic and home (video telehealth) therapy model.

Eligibility Criteria:
Inclusion Criteria:

* Age at enrollment: between 3-8 months corrected age
* Caregivers fluent in English
* Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR
* High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either:

  * "Absent" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR
  * A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)

Exclusion Criteria:

* Medical conditions that restrict active participation such as oxygen dependence
* Infants with significant visual deficits defined by the inability to track an object horizontally
* Living in a remote location prohibiting drives to the hospital every other week.
Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

The purpose of this research study is to understand the safety, pharmacokinetics and pharmacodynamics of a single dose of TT30 (ALXN1102 and ALXN1103 formulations) when given IV (through a vein) or SC (under the skin) to patients with PNH.

This is an open-label, single-dose, dose-escalation study to assess the safety, tolerability, PK, PD, and immunogenicity of TT30 given as an IV infusion and as a SC injection in subjects with PNH or evidence of circulating PNH cells.

Eligible subjects with PNH will be vaccinated with meningococcal vaccine at least two weeks prior to dosing (if not previously vaccinated or if revaccination is required).

On study day 1, the subject will receive the single dose of TT30 as an IV infusion over 60 minutes or as a SC injection, and be followed with additional study evaluations over the next 59 days.

Eligibility Criteria:
Inclusion Criteria:

* Individuals at least 18 years of age with a diagnosis of PNH \& vaccination against meningococcus.

Exclusion Criteria:

* Abnormal renal or liver function
* History of meningococcal disease
* History of Guillain-Barre syndrome
* Known infection with HIV or Hepatitis B or C
* History of thrombotic events
Following Outcomes Remotely Within Addiction Recovery Domains

The aim of this study is to describe outcome of people with opioid use disorder over the long-term by collecting monthly and yearly data on their recovery. Adults with opioid use disorder who participate will complete surveys monthly online and once per year by phone about their substance use, mental health, treatment involvement and functioning. The goal of this study is to better understand how people with opioid use disorder recover over time to improve intervention for this group.

This is a longitudinal follow-up study that will collect yearly outcomes data on adults with opioid use disorder (OUD) who participated one of two prior clinical trials in the NIDA Clinical Trials Network. This longitudinal, observational study will entail annual phone and online assessments of domains of interest (e.g., substance use, treatment engagement) as well as monthly assessments that are distributed via text messaging and email to be completed electronically by the participant. No participant randomization will occur for this study, and study data will be considered observational in nature. We aim to characterize the long-term course of OUD and to evaluate the long-term course and recovery of OUD.

Eligibility Criteria:
Inclusion Criteria:

1. Be an enrolled participant in one of two applicable clinical trials and be no longer than 24 months after the final expected assessment for that trial.
2. Be willing and able to provide locator information for survey distribution (mobile number and/or email address).
3. Be willing to allow the linkage of prior clinical trial study data to the current study record.

Exclusion Criteria:

1. Unable to understand or communicate to complete consent or study assessments.
2. Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
3. Other factors that would cause harm or increased risk to the participant or close contacts or preclude the participant's full adherence with or completion of the study.
Stage II/III Colorectal Cancer Recurrence

This study will develop an assay to predict disease recurrence in patients with stage II/III CRC after receiving adjuvant chemotherapy, using genome-wide DNA methylation.

Adjuvant chemotherapy (ACT) is the standard clinical care for patients with stage III or high-risk stage II colorectal cancer (CRC) after curative-intent resection. Nonetheless, more than 30% of patients experience CRC recurrence. Accurate prediction of recurrence risk in stage II/III CRC patients who undergo ACT is crucial for determining the necessity and duration of ACT, as well as for tailoring novel treatment strategies for these patients.

This study will comprise three phases

1. A systematic and comprehensive CpG methylation-based epigenetic biomarker discovery phase to identify the differentially methylated CpG sites associated with recurrence-free survival (RFS) \< 5 years and \> 5 years. In this phase, LASSO-based machine learning algorithms will be used to optimize the biomarker candidates.
2. A tissue-based clinical assay development phase by quantitative pyrosequencing
3. An independent validation phase.

At completion, this study will validate a tissue-based assay to predict the development of recurrence after the completion of chemotherapy in patients with stage III and II CRC

Eligibility Criteria:
Inclusion Criteria:

* Stage II (high-risk) or III colorectal cancer (TNM classification, 8th edition).
* Received standard diagnostic, staging, and therapeutic procedures as per local guidelines
* Received stage-specific curative-intent resection followed by adjuvant chemotherapy.
* Confirmed cancer-free survivorship confirmed at the time of study inclusion.

Exclusion Criteria:

* Lack of written informed consent.
* Development of recurrence in the first 6 months following adjuvant chemotherapy completion.
* Hereditary colorectal cancer syndromes (identified through genetic testing)
* Inflammatory bowel diseases