cyrilzakka/clinical-trials huggingface dataset:
PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor

To explore the value of PTC drug screening technique in selecting neoadjuvant therapy for advanced gastrointestinal cancer.

In this study, patients diagnosed with advanced gastrointestinal cancer including locally advanced gastric cancer, locally advanced colorectal cancer and colorectal cancer with liver metastasis. Tumor sample will be collected by endoscopy biopsy, needle biopsy or surgery, which will used for PTC drug screening.

Patients will be randomized to two groups. Patients in experiment group will receive neoadjuvant therapy based on PTC drug screening, and patients in control group will receive neoadjuvant therapy based on clinical experience. 2-4 cycles of neoadjuvant therapy will be administered. Patients appropriate for surgery will receive radical surgery after neoadjuvant therapy. Pathological response will be compared primarily between these two groups.

This is a randomized controlled, open-label and sequential designed clinical trial. All neoadjuvant therapy used in this study or for PTC drug screening comply with NCCN (National comprehensive cancer network) or CSCO (Chinese Society of Clinical Oncology) guidelines.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed of gastrointestinal adenocarcinoma by biopsy
* existence of initially resectable lesions evaluated by investigators
* indications of neoadjuvant chemotherapy including: 1) locally advanced gastric cancer cT1-2N1-3M0 \& cT3-4N0-3M0; 2) locally advanced colorectal cancer cT3-4 or N+; 3)colorectal carcinoma with synchronous liver metastases: CRS≤2; 4)other patients who are considered to be appropriate to receive neoadjuvant chemotherapy determined by MDT
* never receive any tumor related treatment including chemotherapy, radiotherapy, and immune therapy
* never diagnosed of other malignancies
* able to tolerate chemotherapy
* ECOG≤2
* life expectance \>6 months
* at least 1 measurable lesions(according to RECIST 1.1)
* informed consent

Exclusion Criteria:

* pregnant or lactating women
* participating in other clinical trials within 6 months
* MSI-H or dMMR or EBER(+)
* lesion located within 10cm from anal margin
* severe liver dysfunction
* severe renal dysfunction
* cognitive disorder, mental disease or poor compliance
* allergic to known chemotherapeutic agents
* other conditions not suitable to participate in this trial determined by investigators
Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)

Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.

Seventy patients with irritable bowel syndrome (IBS) will be randomized to either 1) placebo pill or 2) no treatment and followed for 3 weeks. The study will involve three visits: baseline, midpoint and end point. At baseline all patients will physical examination, be evaluated for IBS and be administered standardized IBS questionnaires including: "IBS adequate relief" questionnaire, IBS global symptom improvement scale, IBS quality of life and IBS symptom severity scale. At midpoint and endpoint the same questionnaires will be administered. Patients on no treatment will be offered education on managing IBS at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Irritable bowel syndrome.

Exclusion Criteria:

* Any signs of organic bowel disease such as rectal bleeding.
* No other major illnesses.
Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration

Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)

The purpose of this study is to allow the collection of tissue from subjects to be used in future research studies by scientists and to isolate tumor fighting cells for the future treatment of Melanoma.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have metastatic melanoma with a resectable metastasis who are undergoing resection for palliation, therapeutic or curative purpose.
2. Patients must be \> 15 years of age and must have metastatic melanoma.
3. Patients must meet standard pre-operative requirements as determined by the surgeon to be candidates for surgery.
4. Patients must be able to understand and sign the Informed Consent document.
5. Patients must be able to complete the supplemental data form

Exclusion Criteria:

1. women who are pregnant or breastfeeding
2. inability to give consent
Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.

The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease

Endoscopic biopsy currently plays only a minor role for the diagnosis of interstitial lung disease. However, in some cases obtaining lung tissue is necessary to establish a final diagnosis. The current standard procedure is transbronchial forceps biopsy - if not sufficient: surgical lung biopsy. Transbronchial lung biopsy bears essential limitations however:

* Small tissue sample
* Limited evaluability of the material caused by forceps-induced crush artifacts

In cryobiopsy the cryoprobe´s tip is being cooled and thereby cools the surrounding tissue to approximately minus 89 degrees Celsius. Subsequently, the frozen probe is retracted with the frozen tissue being attached onto the frozen probe's tip. When applied in the central airways, cryobiopsy proved to deliver large specimens of good quality, which may exceed forceps biopsies in terms of diagnostic yield. Pilot studies on transbronchial cryobiopsy showed that same advantages as seen in the endobronchial use.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical indications for biopsy of interstitial lung disease
2. Age over 18 years
3. Signed consent

Exclusion Criteria:

1. Risk of bleeding / ongoing anticoagulation
2. Oxygen saturation \<90% - despite delivery of 2l oxygen / min
3. Underlying cardiac disease (unstable angina, myocardial infarction during the last month, congestive heart failure)
4. Pulmonary hypertension, PAP sys\> 50mmHg
A Combined Supplementation of Rosemary and Daylily for Enhancing Sleep Quality in Middle-Aged Adults

This study aims to investigate the impact of supplementation with two different doses of Rosemary and Daylily herbal extract on various health outcomes in middle-aged adults. Over an eight-week period, the trial will assess improvements in sleep quality, circadian rhythms, energy metabolism, and relevant biochemical markers. The study employs a randomized, placebo-controlled, crossover design to evaluate the efficacy of these supplements in enhancing overall health and well-being.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Trouble falling asleep \> 5 times a month (NHANES criteria)
* Body mass index 18.5-29.9 kg/m2
* Free of major chronic diseases or acute disorders
* Given written informed consent

Exclusion Criteria:

* History of dietary supplement use \> 2 weeks before the study commences
* Abnormal values for lab clinical chemistry (\> 2 SD)
* Unwillingness to return for follow-up analysis
* Participation in other clinical trials
* Moderate-to-heavy use of alcohol (\> 3 drinks per week)
First-in-human Study of OT-A201 in Patients with Selected Hematological Malignancies and Solid Tumors

This phase 1 study is aimed at establishing the safety basis of OT-A201 in the treatment of hematological malignancies and solid tumors. In the dose of escalation part it is to characterize the overall safety and tolerability profile and determine the recommended dose(s) of OT-A201 as monotherapy, and in various combination regimens. Preliminary information about anti-cancer activity will be further explored in the expansion part of the study.


Eligibility Criteria:
Main Inclusion Criteria:

* Histologically or cytologically confirmed relapsed/refractory hematological malignancy or advanced/metastatic solid cancer
* Measurable disease
* Have had all available therapeutic standards for their disease
* Willingness to undergo baseline biopsy/bone marrow aspiration in case biopsy was not collected after completion of the most recent prior therapy
* ECOG performance status ≤ 1
* Life expectancy \> 3 months as assessed by the investigator
* Acceptable clinical lab results

Main Exclusion Criteria:

* Systemic steroids at a daily dose of \> 10 mg of prednisone or equivalent within 28 days before study treatment. Transient use of steroids for other medical condition may be allowed
* Ongoing immune-related adverse events irAEs and or AEs ≥ grade 2 from previous therapies not resolved except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
* Within 4 weeks of major surgery
* Documented history of active autoimmune disorder requiring systemic immunosuppressive therapy within the last 12 months
* Prior solid organ transplant
* Primary or secondary immune deficiency
* Active and uncontrolled infection requiring intravenous antibiotic or antiviral treatment
* Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Clinically significant disease
Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)

The focus of this study is to assess the differences in patient perceptions of pain undergoing cataract surgery by using the Refractive Laser-Assisted Cataract Surgery (ReLACS) technique compared to the standard Manual Cataract Surgery (MCS) technique using an immediately sequential bilateral approach. This study also aims to further explore difference in patients' perceptions of pain depending on timing of neurolept anesthesia in the ReLACS technique. The importance of this study is appreciated patient perception of pain during ReLACS, which is an emerging technique for cataract surgery and has been sparsely reported on to date. This investigation will include the analysis of various surgical, ocular, medical, and psychosocial metrics of patients undergoing both ReLACS and MCS at Uptown Eye specialist.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing uncomplicated cataract surgery with either surgical technique (M-ISBCS or ReLA-ISBCS)
* Patients who require surgery in both eyes by the same surgeon
* Able to understand English and complete a pain assessment (NRS)

Exclusion Criteria:

* Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery
* Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy)
* Pre-existing uncontrolled glaucoma/high IOP
* Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery)
* Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan
* Patients under 40, severe obesity (BMI \>35)
* Chronic pain/narcotics/recreational or medical marijuana
Group Therapy for Women Prisoners With Comorbid Substance Use and Depression

The purpose of the study is to determine whether interpersonal psychotherapy is effective for treating co-occurring depression and substance use among women prisoners.

Incarcerated women are a vulnerable and rapidly expanding population with high lifetime rates of both substance use disorder (SUD; abuse or dependence on alcohol, illegal drugs, or prescription drugs; 70%) and depressive disorder (DD; major depressive disorder and dysthymic disorder; 20-27%). DDs tend to worsen the course of SUDs for incarcerated women by increasing their risk for suicide attempts, contributing to the persistence of substance abuse, and reducing the likelihood of a successful transition to an independent, sober life in the community. Recent evidence indicates that DDs are common in persons with SUDs, often do not remit with SUD treatment, and should be treated. Despite growing recognition that co-occurring disorders, such as DDs, among substance abusing incarcerated women present an important public health concern, integrated treatments for SUD-DD have not been well-developed for or systematically tested in this population. Group Interpersonal Psychotherapy (IPT-G) has been shown to be efficacious in treating DD in other populations and may be especially pertinent to the needs of incarcerated women with SUD-DD because interpersonal difficulties not only affect severity of depression, but are also strong predictors of drinking to cope, SUD relapse, and prison recidivism in women.

This study tests the hypotheses that as adjuncts to prison SUD treatment, IPT-G, relative to psychoeducation on co-occurring disorders, will produce at least moderate effect sizes for:

* Reduction in the risk and severity of substance use relapse after release from prison
* Recovery from depressive disorder and reduction in depressive symptoms
* Improvement in social support and interpersonal functioning
* Reduction in the severity of legal problems during the 3 month follow-up period

Eligibility Criteria:
Inclusion Criteria:

* Participants are recruited from prison substance use treatment programs.
* Current primary (non-substance-induced, as defined by the SCID) depressive disorder (major depressive or dysthymic disorder) after at least 4 weeks of prison SUD treatment and abstinence.
* A minimum Hamilton Depression score of 18 or higher, indicating moderate to severe depression.
* Depressive disorder at any time while not incarcerated.
* Substance use disorder one month prior to incarceration.
* Between 10 and 18 weeks away from release from prison.

Exclusion Criteria:

* Lifetime criteria for bipolar disorder
* Lifetime criteria for a psychotic disorder
* Actively suicidal
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

This study is a randomized controlled trial (RCT) to assess the feasibility, tolerability, and safety of using opioid receptor antagonists (naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol use and chronic pain.

Pain is a common co-morbidity for HIV-infected patients. Prevalence studies suggest that, on average, half of all HIV-infected persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-infected persons, which may in turn be a barrier to treatment/control of HIV and contribute to spread of HIV. Thus there is an urgent need to address pain among persons with HIV. Opioid receptor antagonists such as naltrexone and nalmefene, which are licensed for treatment of alcohol use disorders, show promise as being effective and safe treatments for chronic pain among persons with HIV. This study will pilot test novel pharmacotherapies (opioid receptor antagonists) to improve chronic pain among HIV-infected heavy drinkers. The specific aims of the research is to assess the feasibility, tolerability and safety of using opioid receptor antagonists (low-dose naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol use and chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* HIV-positive
* Chronic pain (present ≥3 mo) of moderate to severe intensity
* Heavy drinking past year (Based on NIAAA criteria: \> 14 standard drinks per week/ \> 4 drinks in a day for men; \> 7 drinks in the past week/ \> 3 drinks in a day for women)
* If female, negative pregnancy test and willing to use adequate birth control
* Provision of contact information for 2 contacts to assist with follow-up
* Stable address within 100 kilometers of St. Petersburg
* Possession of a telephone (home or cell)
* Able and willing to comply with all study protocols and procedures

Exclusion Criteria:

* Not fluent in Russian
* Cognitive impairment resulting in inability to provide informed consent based on research assessor (RA) assessment
* Known active TB or current febrile illness
* Breastfeeding
* Uncontrolled psychiatric illness (such as active psychosis) (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the ED or hospital)
* History of hypersensitivity to naltrexone, nalmefene, or naloxone
* Current use (past week) of illicit or prescribed opiates as documented by either self-report or positive urine drug test
* Unwilling to abstain from opiates during the treatment period
* Current use of neuroleptics
* History of seizure disorder
* Known liver failure
* ALT/AST levels \>5x normal
* History of Raynaud's Disease
* Planned surgeries in the next three months
* Enrolled in another HIV and/or substance use medication intervention study
* Taking naltrexone in the past 30 days
* Taking nalmefene in the past 30 days
Surgery of the Pilon Fractures

The assessment consists in comparing the osteosynthesis plate with minimally invasive technique versus open reduction and internal fixation.

The aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.

Several surgical techniques exist and among plate osteosynthesis, there is a minimally invasive method and the open reduction method.

Investigators think that the minimally invasive method with intern plate is more efficient than the open reduction method.

These techniques may better preserve perifracture soft tissues, hematoma. It may lead to a smaller muscle detachment.

The minimally invasive technique allows a more efficient vascularization of the fracture site, what would increase bone healing and the functional prognosis of tibial pilon lesions.

It's all these issues investigators would like to assess with a randomized study.

Eligibility Criteria:
Inclusion Criteria:

* More than 18-year-old with opened or closed pilon fracture Cauchoix type 1,
* signed patient consent

Exclusion Criteria:

* Open pilon fracture cauchoix type 2 or 3,
* infection of the operating site,
* previous osseous disease
* patient who are unwilling or unable to give consent
A Study to Check How Often People Treated With Darvadstrocel for Crohn's Disease Are Diagnosed With Cancer

The main aim is to learn about the risk of cancer after treatment with darvadstrocel compared to other standards of care in people with Crohn's Disease (CD).

In this study, the study doctors will review each participant's past medical records. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

This is a retrospective, non-interventional study of participants with complex perianal fistula in Crohn's disease (CPF-CD). This study will assess tumorigenicity risk and all-cause and cancer-specific mortality in participants with darvadstrocel.

The study will enroll approximately 5850 participants. Data will be collected retrospectively from European secondary data sources. Participants will be assigned to two cohorts:

* Darvadstrocel cohort
* Matched control cohort: Alternate SoC.

This multi-center trial will be conducted in France, Germany, Netherlands, and Spain. The overall duration of the study will be approximately 96 months, including index period (the time in which eligible participants are included in the study) and 12 months follow-up period.

Eligibility Criteria:
Inclusion Criteria:

Darvadstrocel cohort 1. Participants will be included in the darvadstrocel cohort if they have at least one record of prescription/dispensation/administration of darvadstrocel at some point during the study period.

Comparator cohort

1. A comparator cohort of controls (matched control cohort) will be composed of participants with CD and PF randomly selected from a pool of eligible participants with no history of administration of darvadstrocel.

Exclusion Criteria:

1. Has less than 12 months of uninterrupted data within country-specific data source prior to index date.
2. Has not meet quality indicators for country-specific data source (if applicable).
3. Has diagnosis of cancer prior different from non-melanoma skin cancer to index date. This will minimise the misclassification of prevalent or metastatic cancer as incident cases for the analysis of the study objectives.
4. Has diagnosis of ulcerative colitis at any point during the study period and medical history period. This will avoid potential ascertainment bias as there is currently no gold standard for differential diagnosis in IBD. Approximately 5 percent (%) to 15% of cases do not meet strict criteria for either ulcerative colitis (UC) or CD and in up to 14% of participants classified as UC and CD, the diagnosis changes over time.
5. Has record of proctectomy or colectomy prior to index date. Proctectomy and colectomy are considered "last chance" surgery options for anal fistulas or other complications of CD. These participants are not the target population for darvadstrocel. They would not be eligible for darvadstrocel administration and loss of their gastrointestinal tract would affect the risk of colorectal cancer; the most common cancer associated with CD.
The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein

This study has been developed to investigate the anti-inflammatory effects of a commercial product (Nopalea) containing Prickly Pear Cactus Fruit Juice in healthy adults. The research method employs a double blind, placebo controlled, and time-series (repeat measures) design with high-sensitivity C-Reactive Protein (HS-CRP) serving as a marker for inflammation - testing for levels of CRP at time points: baseline (pre-test), 8 weeks (60 days) and 12 weeks (90 days). The final time point (i.e., 12 weeks) will serve as the post-test. It is expected that baseline CRP levels in healthy participants will decline.


Eligibility Criteria:
Live within traveling distance of the research center. Access to a telephone in their residence. Between 35 and 75 years of age Not currently ingesting Nopalea Not pregnant, planning to become pregnant, or nursing a child Not currently taking anti-inflammatory medications Medically stable - i.e. no recent major change in the last 3 weeks of prescription or non- prescription medication Not diagnosed with Type 1 Diabetes Not diagnosed with depression Not diagnosed with an acquired or congenital immune system deficiency
Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity

A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over a two week treatment period.


Eligibility Criteria:
- Subjects who suffer from tooth sensitivity.