cyrilzakka/clinical-trials huggingface dataset:
Study of NK012 in Patients With Refractory Solid Tumors

The purpose of this study is to determine whether NK012 is safe and effective in the treatment of refractory solid tumors

This is a Phase I dose-escalation study of the intravenous administration of NK012 in patients with refractory solid tumors. Patients will receive NK012 as an intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients with UGT1A1\*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/\*28) variants as one group, and patients with UGT1A1\*28 homozygous variant (\*28/\*28) as another group.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant solid tumor for which there are no known regimens or protocol treatments of higher efficacy or priority
* Failed conventional therapy for the cancer or have a malignancy for which a conventional therapy does not exist
* Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss)
* Life expectancy of at least 12 weeks and an EOCG performance status of 0 or 1
* 18 years of age or older
* Adequate kidney, liver, and bone marrow function
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse effects due to agents administered more than 4 weeks earlier
* Receiving any other investigational agent
* History of brain metastases or spinal cord compression, unless irradiated a minimum of 4 weeks before study entry and stable without requirement for corticosteroids for \> 1 week
* History of allergic reactions attributed to compounds of similar chemical composition to NK012
* Concurrent serious infections (i.e., requiring an intravenous antibiotic)
* Pregnant women or women of childbearing potential who are not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline and before every NK012 administration for women of childbearing potential; no breast-feeding while on study
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements
* Significant cardiac disease
* History of serious ventricular arrhythmia
* Positive for anti-HbsAg, anti-HCV, anti-HIV, or anti-syphilis antibodies
Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches

The purpose of this study is to examine the effectiveness of 3 behavioral weight loss programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined approach which includes university-based treatment followed by Weight Watchers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 30-65 years
* BMI between 27-50 kg/m2
* Written approval/consent from primary health care provider

Exclusion Criteria:

* Unable to walk 2 blocks without stopping.
* Currently participating in a weight loss program or taking weight loss medication.
* Participated in a weight loss program in the last year
* Took weight loss medication in the last 6 months.
* Participated in Weight Watchers in last 2 years.
* Lost \>=5% of body weight during 6 months prior to screening.
* Pregnant, lactating, less than 6 months postpartum, or plan to become pregnant during study time frame.
* Report conditions that in the judgment of the principal investigator would render them potentially unlikely to follow protocol for the 12 month study.
* Report a medical condition that would affect the safety and/or efficacy of a weight management program involving changes in diet and physical activity.
Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects

Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111

This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A will receive a single dose of BGB-3111 before and during consecutive daily doses of strong cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor, itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI)18 - 32 kg/m2, inclusive.
2. Subjects of Asian (first- or second-generation) and non-Asian descent.
3. In good general health as assessed by the Investigator.
4. Females must be nonpregnant and nonlactating, and females of childbearing potential will agree to use required contraception.
5. Males without a vasectomy will agree to use required barrier contraception, and will agree to not donate sperm from the time of the first dose of BGB-3111 until ≥90 days after the last dose of BGB-3111.Able to comprehend and willing to sign consent.

Exclusion Criteria:

1. Subjects with a clinically relevant history or presence of any clinically significant disease.
2. Evidence of bacterial, viral, fungal, parasitic infections within 4 weeks prior to the first dose of study drug.
3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
4. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
5. History of alcoholism or drug/chemical abuse within prior year.
An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery

The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery from opioid use disorder (OUD) over a 24-month period following exit from a Phase III clinical program for a buprenorphine extended-release injection (RBP-6000). The study population will consist of participants from studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003).

The RECOVER study will characterize OUD subjects' recovery process as they transition from the controlled clinical trial environment to the real world setting.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who received at least one injection in RBP-6000 or placebo in the Phase III clinical program which includes study protocols NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003) and either withdrew from or completed these studies.
* Ability to comply with study protocol requirements for data collection and provide informed consent.
Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of OSA With CPAP

Our group previously conducted a study looking at the performance of three styles of positive airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we found that patients using a full-mask mask required higher positive airway pressures than patients using nasal or nasal pillows style masks to achieve successful reduction of respiratory events. In the current study we want to randomly assign patients to either nasal or full-face masks and then switch to a different mask (if nasal was originally chosen than the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the number of respiratory events change with the different mask style. We expect the number of respiratory events will increase with the use of full-face masks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* previously diagnosed with OSA
* returning for PAP titrations at the Center for Sleep Medicine
* CPAP and titration naive
* Must have a Apnea/Hypopnea Index (AHI) of ≥ 16/hr.

Exclusion Criteria:

* Patients with ≥ 50% central apneas
Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing diagnostic or therapeutic ERCP.

Exclusion Criteria:

* Unwillingness or inability to consent for the study;
* Age \< 18 years old;
* Intrauterine pregnancy;
* Breastfeeding mother;
* Standard contraindications to ERCP;
* Allergy to NSAIDs;
* Received NSAIDs in prior 7 days;
* Renal failure (Cr \>1.4mg/dl=120umol/l);
* Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;
* Acute pancreatitis within 72 hours;
* Known pancreatic head mass;
* Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;
* ERCP for biliary stent removal or exchange without anticipated pancreatogram;
* Known active cardiovascular or cerebrovascular disease.
* Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;
Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer

Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18 years or older
* Documented metastatic adenocarcinoma of the prostate
* Under active medical oncology care
* ECOG performance status 0 - 3, inclusive
* Able to understand and provide written informed consent
* Able to tolerate the physical requirements of two PET/CT scans including lying for up to 30 minutes
* Progressive disease on any of: bone scan, CT, MRI or serum PSA as judged by the investigator
* Serum prostate specific antigen ≥ 1 ng/ml at baseline or CT/MRI soft-tissue measurable disease as per RECIST v1.1
* Failed, failing, refused, no access to or not eligible for any approved prostate cancer therapies including but not limited to: ADT, NAAD (e.g., abiraterone, enzalutamide, darolutamide or apalutamide), docetaxel, cabazitaxel, radium-223 and oligometastatic RTX
* Life expectancy of at least 3 months as judged by the investigator

Exclusion Criteria:

* Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
* Exceeding the weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (approximately 70 cm diameter)
* Unmanageable claustrophobia
* Prior failure of PSMA RLT
* Prior hemi-body irradiation
* Impaired organ function as evidenced by any of the following laboratory values:

  * Absolute neutrophil count \< 1.5 x109/L
  * Platelet count \< 75 x109/L
  * Hemoglobin \< 85 g/L
  * Albumin \< 2.5 g/dL (25 g/L)
  * Total bilirubin \> 2 x ULN (unless in instances of Gilbert's disease)
  * AST or ALT \> 2.5 x ULN (or \> 5.0 x ULN in the presence of liver metastases)
Influencing Factors of Helicobacter Pylori Infection and Eradication Failure

Helicobacter pylori (H. pylori) is closely related to the occurrence of gastric cancer and other diseases, the discovery and eradication of H. pylori infection has great significance to the prevention and treatment of related diseases. At the same time,understanding the influencing factors of H. pylori infection and eradication failure in the population can provide a scientific basis for the formulation of local H. pylori prevention and control strategies. So, the investigators intend to analyze the factors related to H. pylori infection and eradication failure in the outpatients of gastroenterology clinics in Xi'an, China.

Taking 300 permanent residents in Xi'an area who will go to the Gastroenterology Clinic of the Second Affiliated Hospital of Xi'an Jiaotong University from February 2022 to March 2023 and undergo 13C-UBT examination as the research object. A questionnaire survey on factors related to H. pylori infection and eradication failure will be conducted. The questionnaire includes basic Information, eating patterns, living environment, related gastrointestinal symptoms, etc. Among the outpatients, H. pylori-positive patients will be given rabeprazole 10 mg + amoxicillin 1000 mg + clarithromycin 500 mg + colloidal bismuth tartrate 220 mg bid for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT will be performed to determine whether H. pylori is eradicated. According to the results of 13C-UBT at the beginning and results of 13C-UBT after eradication treatment, outpatients will be divided into three groups: H. pylori negative group, H. pylori positive radical cure successful group and H. pylori positive radical cure failed group. Next using SPSS 19.0 Statistical software analyzes H. pylori infection and eradication failure related influencing factors. According to the analysis, the investigators can provide a scientific basis for local formulation of correct and effective H. pylori prevention and control strategies.

Eligibility Criteria:
Inclusion Criteria:

1. Perform 13-UBT,
2. Be able to understand the content of the questionnaire and answer the questions accurately,
3. Permanent residents of Xi'an area,
4. No previous HP eradication treatment,
5. Agree to join the group and sign the informed consent form,
6. Aged between 18-70.

Exclusion Criteria:

1. Complicated with serious cardiovascular, respiratory, blood, liver, kidney, nerve or endocrine system diseases,
2. Mental disease,
3. Gastric or esophageal surgery history,
4. Severe atypical hyperplasia of gastric epithelium, gastric malignant tumor or other malignant diseases
5. Pregnant or lactating women,
6. Patients with history of penicillin allergy,
7. Allergy to rabeprazole, bismuth dose, clindamycin,
8. Have taken proton pump inhibitors,H2 receptor antagonists, within 2 weeks before participating in the inspection,
9. Have taken herbs that have bacteriostatic effect or antibiotic or bismuth agents within 4 weeks before participating in the inspection.
S095035 in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene

This is a first-in-human Phase 1, multicenter, open-label dose escalation study of S095035 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \[MAT2A\] inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Estimated life expectancy ≥3 months.
* ECOG PS 0-1
* Participants able to comply with highly effective method of birth control requirements.
* Participants with histologically confirmed advanced or metastatic solid tumor's (excluding central nervous system tumors) that have progressed despite at least one prior treatment regimen given for advanced/metastatic disease, and for whom additional effective standard therapy is not available.
* Participants with pre-existing documented MTAP homozygous deletion in their tumor tissue, determined using a next generation sequencing in vitro diagnostic test prior to screening.
* Participants willing to undergo paired fresh biopsy (pre-treatment and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns.
* Adequate organ functions.

Exclusion Criteria:

* Inability to take an orally administered drug, or medical disorder or prior surgical resection that may affect the absorption of the study drug.
* Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's Medical monitor and investigator agree and document that it should not be exclusionary.
* Known prior severe hypersensitivity to any component of the study drug formulation.
* Major surgery within 4 weeks prior to the first IMP administration or participants who have not recovered from side effects of the surgery.
* Have a known history of Gilbert's syndrome.
* Participants with a known clinically significant cardiovascular disease or condition.
* Participants with thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration.
* Active brain metastases.
* Current active liver or biliary disease.
* Participants who have received systemic anticancer treatment or radiotherapy less than 2 weeks before the first dose of S095035. Participants who have not recovered from toxicity of previous anticancer therapy.
Cost Evaluation of Robotic Ventral Hernia Repair

To evaluate the procedural cost of robotic ventral hernia repair compared with open ventral hernia repair.

Ventral hernia repair is one of the most frequently performed elective surgeries worldwide. The surgical approaches vary depending on the patient characteristics, type, and location the of ventral hernia, as well as the surgeons' preferences and equipment availability.

The choice between an open or minimally invasive approach has been debated for years, and it seems clear that the risk of wound infection is significantly decreased when choosing a minimally invasive approach, whereas there are no significant difference in recurrence rates. In the past decades, the use of a robotic system for ventral hernia repair has gained increasing popularity due to an easy access to the preperitoneal or retromuscular plane with a minimally invasive technique.

Two nationwide cohort studies concluded that length of stay and postoperative morbidity was decreased for robot-assisted repairs compared to open or laparoscopic ventral hernia repairs. Critics of robot-assisted surgery argue that it is time-consuming, too expensive, and that further cost-effectiveness analyses are needed to weigh the clinical benefits.

The aim of these studies was to compare the procedure-specific cost of robot-assisted with open primary ventral and incisional hernia repair and thereafter with laparoscopic repairs.

Eligibility Criteria:
Inclusion Criteria: patients undergoing elective primary ventral and incisional hernia repair -

Exclusion Criteria: none

-
Safety and Efficacy of Intravenous Valproate in Pediatric Status Epilepticus and Acute Repetitive Seizures

To evaluate the safety and efficacy of intravenous valproate in pediatric status epilepticus and acute repetitive seizures as part of seizure treatment protocol in pediatric ER


Eligibility Criteria:
Inclusion Criteria:

* Child with clinical presentation of status epilepticus

Exclusion Criteria:

* All others
Pilot Study of OXP001(2) and Brufen in Healthy Subjects

The study will compare the study drug to an already marketed formulation of prescription strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.

The study will consist of 2 parts involving up to 54 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product. Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of 800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001 or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach irritation using endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subject
* Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum) (Part 2 only)
* H. pylori negative

Exclusion Criteria:

* Clinically significant abnormal laboratory parameters
* Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, GI or any other body system
Characterization of the Sleep-Wake Cycle in Traumatic Brain Injury Patients with a Disorder of Consciousness

Each year in France, 160,000 peoples suffer from a mild or severe traumatic brain injury (TBI). Sleep plays a crucial role in the process of brain plasticity, which is essential for neurological and cognitive recovery. However, the sleep-wake cycle is rarely, if ever, evaluated in patients with TBI and consciousness disorders within Post-Resuscitation Rehabilitation Units (SRPR). Caregivers develop, on a daily basis, an intuitive understanding of the patient's overall condition. This expertise deserves to be validated using objective sleep assessment tools (actigraphy). If proven accurate, it could lead to the implementation of a sleep-wake cycle evaluation protocol within SRPRs.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the Post-Resuscitation Rehabilitation Unit or the Neurological Intensive Care Unit
* Consciousness disorders: Vegetative State or Minimally Conscious State (according to the CRS-R)
* Traumatic brain injury
* Patient aged 18 years or older
* Presence of relatives able to express non-opposition to the study
* Subjects affiliated with a social security scheme (or beneficiaries)

Exclusion Criteria:

* Admission for status epilepticus
* Individuals admitted to a healthcare or social care facility for purposes other than research
* Adults under legal protection measures (guardianship, conservatorship)
* Individuals not affiliated with a social security scheme or not benefiting from a similar scheme