cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma

This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.

Thymic carcinomas are particularly more concerning due to their aggressive metastatic nature and shorter overall survival, in comparison to their lesser-malignant thymoma counterparts. This necessitates the need for systemic therapy. Due to the paucity of thymic carcinoma cases, the ideal regimen for locally advanced or metastatic thymic carcinomas is not defined.To this point, there has not been a study using imatinib in thymic tumors expressing the KIT tyrosine kinase protein or PDGF tyrosine kinase protein. This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proof of advanced C-KIT positive or PDGFR positive thymic carcinoma. For protocol purposes, advanced disease is defined as disease
* Patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
* No prior imatinib therapy.
* Age \> 18 years at the time of consent
* ECOG performance status of 0 or 1
* ANC ≥ 1500/mm3,Platelet count ≥ 100,000/mm,Total bilirubin \< 1.5ULN,3.10 Serum creatinine ≤ 1.7 mg/dl,ALT and AST ≤ 3 x ULN

Exclusion Criteria:

* Clinically significant infections as judged by the treating investigator
* Clinically significant concurrent illnesses
* Females of childbearing potential not using birth control or breastfeeding
* Prior radiation therapy \> 25% of the bone marrow
* Symptomatic brain metastasis
* History of Grade III/IV cardiac problems
* History of major surgery within 14 days prior to being registered
* Treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success

There is no consensus on antibiotic prophylaxis in dental implant applications, and its necessity is controversial. Current reports on antibiotic use are insufficient. Also, other than antibiotic prophylaxis, data that may affect the post-operative situation such as the patient's gender, age, smoking, duration of surgery, length of the operation field, flap design have not been evaluated comprehensively.

This study aims to evaluate post-operative complications, implant success, and implant stability in 50 individuals: preoperative single dose of 2 g amoxicillin + clavulanic acid (25) and placebo (25).


Eligibility Criteria:
Inclusion Criteria:

* Tooth loss

Exclusion Criteria:

* Systemic disease
* Lactation/pregnancy
Homecoming Line: Telephone Support for Veterans

This study will determine whether telephone support improves clinical outcomes of veterans who begin outpatient treatment for posttraumatic stress disorder. Participants will be randomly assigned to receive either usual care or usual care supplemented by biweekly monitoring and support by telephone during the first 3 months of treatment. Patients in both conditions will be compared on PTSD symptoms, engagement in treatment, violence and drinking at 4 months and 12 months after entering treatment.

This multisite randomized controlled trial will test whether a 3-month period of providing telephone monitoring to PTSD patients as a supplement to usual specialty mental health care improves 12-month clinical outcomes (a reduction in PTSD symptoms, violence, and substance use). Secondarily, this study will determine whether telephone monitoring promotes better engagement in outpatient treatment (Number of mental health and psychotherapy visits during the 3-month intervention period).

Demand for VA PTSD treatment is increasing as troops return from combat deployments in Afghanistan and Iraq. Telemedicine is likely to be an important component in developing more effective and efficient models of PTSD care that improves patient functioning and treatment utilization. It is hoped that using telephone case monitoring as an inexpensive adjunct to standard care may improve clinical outcomes and reduce hospitalization among veterans with PTSD.

Eligibility Criteria:
Inclusion Criteria:

* VA patients newly entering outpatient treatment mental health treatment for PTSD starting a new phase of outpatient PTSD treatment (e.g., transitioning from a psycho-education group to active psychotherapy) at one of the study sites.

Exclusion Criteria:

* Active duty personnel
* Cognitive impairment which precludes giving informed consent
* Initiating residential or inpatient treatment rather than outpatient treatment
Molecularly Tailored Therapy for Pancreas Cancer

Patient therapy is tailored according to the molecular profile of the patient's tumor.

This study is for patients with metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to determine whether molecularly tailored therapy can improve the effectiveness of standard chemotherapy combinations for patients with metastatic pancreatic cancer. A series of special tests will be performed on a sample of tumor, and based on the results subjects will be assigned to one of seven chemotherapy treatments, with each being the combination of two standard chemotherapies. Each of these combinations has been safely used in patients with pancreatic or other types of cancer. The purpose of this study is to to determine the ability to personalize therapy in this manner, and to determine how many patients a larger study would need. A second purpose is not to determine if one doublet is better than another. Rather, this second purpose is to show that for all patients enrolled in this protocol who have been assigned a doublet based on their tumor's molecular analysis (molecular tailoring), treatment response will be better than would be expected compared to patients who have been treated in the past with no molecular tailoring.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven pancreatic adenocarcinoma with measurable disease
* Biopsy accessible tumor deposits
* ECOG performance status 0-2
* Age \>/= 18 years
* Subjects with no brain metastases or history of previously treated brain metastases
* Adequate hepatic, renal, and bone marrow function
* Partial thromboplastin time must be \</= 1.5 x upper normal limit of institution's normal range and INR \< 1.5
* Life expectancy \> 12 weeks
* Women of childbearing potential must have a negative seum pregnancy test within 14 days prior to initiation of treatment
* Subject is capable of understanding and complying with parameters as outlines in the protocol and able to sign and date the consents

Exclusion Criteria:

* CNS metastases which do not meet criteria outlines in inclusion criteria
* Active severe infection or known chronic infection with HIV or hepatitis B virus
* Cardiovascular disease
* Life threatening visceral disease or other severe concurrent disease
* Women who are pregnant, breastfeeding, or women of childbearing potential not using dual forms of effective contraception
* Anticipated patient survival under 3 months
* Patients receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biological composition to gemcitabine, oxaliplatin, 5-FU, docetaxel or irinotecan
* Uncontrolled intercurrent illness
A Device Designed to Protect the Perineum During Labor

Objective:

To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.

Design:

A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.

Main outcome measures:

The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.

Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.

Eligibility Criteria:
Inclusion Criteria:

* Vaginal delivery

Exclusion Criteria:

* Age below 18 years and no understanding of written and oral information.
Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS

The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome


Eligibility Criteria:
Inclusion Criteria:

1. MDS subjects with higher risk;
2. Age ≥ 18 years old;
3. Eastern Cooperative Oncology Group score of 0\~1;
4. Not suitable for or refuse to receive HSCT;
5. Newly diagnosed MDS subjects;
6. Adequate organ function;
7. Subjects should take effective contraceptive measures
8. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.

Exclusion Criteria:

1. Subject who has transformed from MDS to AML.
2. Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN.
3. MDS subjects with lower risk.
4. Subjects who have received chemotherapy.
5. Prior exposure to any anti-CD47 or anti-SIRPα agents.
6. Subjects participating in another interventional clinical study.
Effect of Electroacupuncture on Benign Prostatic Hyperplasia

The study aims to assess the efficacy and safety of electroacupuncture among men with benign prostatic hyperplasia (BPH), compared with sham electroacupuncture.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of BPH in accordance with the European Association of Urology (EAU) guideline;
2. Male participants aged between 40 and 80 years;
3. Lower urinary tract symptoms (LUTS) for at least three months;
4. IPSS total score ≥8;
5. Prostate volume ≥20 mL;
6. Urinary peak flow rate (Qmax) ≤15 mL/s;
7. Voluntary participation in the trial and signed written informed content.

Exclusion Criteria:

1. Post-void residual urine volume (PVR) ≥150 mL;
2. Acute urinary retention or catheterization for outflow obstruction within the 3 months (Except for post-surgical disposable catheterization);
3. Prostate cancer or prostate-specific antigen (PSA) level ≥4.0 ng/mL;
4. Neurogenic lower urinary tract dysfunction; prostatitis; uncontrolled symptomatic urinary tract infections; urethral strictures; bladder diverticula; bladder stones; bladder cancer; history of genitourinary system surgery (prostate, bladder, urethra, etc.);
5. Previous acupuncture treatment for BPH in the preceding one month, or α-blockers, 5α-reductase inhibitor, muscarinic receptor antagonists, or any other specific medication usage in the previous two weeks unless a stable 5α-reductase inhibitor usage of over three months;
6. Severe lung, heart, liver, kidney, metabolic, or mental illness, coagulation dysfunction, or with obvious cognitive dysfunction;
7. Installed cardiac pacemaker, allergy to metal, severe fear of acupuncture or unbearable to the stimulation of EA.
Study Testing Convalescent Plasma vs Best Supportive Care

Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.

Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1 shows that convalescent plasma contains neutralizing antibodies to the relevant virus. In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy would mediate protection is viral neutralization. The only antibody type that is currently available for immediate use is that found in human convalescent plasma. As more individuals contract COVID-19 and recover, the number of potential donors will continue to increase. The investigators seek to treat participants who are sick enough to warrant hospitalization prior to the onset of overwhelming disease.

Eligibility Criteria:
Inclusion Criteria Donor:

* 18 years or older
* must have been hospitalized w/COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing but are now PCR negative by 2 nasopharyngeal testing
* females of child-bearing potential must have a negative serum pregnancy test
* subject and/or LAR willing to provide informed consent
* patient agrees to storage of specimens for future testing

Inclusion Criteria Recipient:

* 18 years or older
* must have been hospitalized w/COVID-19 respiratory symptoms within 3 to 7 days from the beginning of illness
* subject and/or LAR willing to provide informed consent
* patient agrees to storage of specimens for future testing

Exclusion Criteria:

* 18 years or older
* receipt of pooled immunoglobulin in past 30 days
* contraindication to transfusion or history of prior reactions to transfusion blood products
* females who are identified as donors must not be pregnant
Therapists' Preferences for Client Characteristics and Their Influence on the Therapeutic Alliance

The research will examine psychotherapists' preferences for theoretical client characteristics, such as age, gender, personality characteristics and symptoms. The research will also examine the preferences' influence on the therapeutic alliance, from the therapist's and the client's point of view.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients over the age of 18,
* Hebrew speakers,
* Not in a psychotic state.

Exclusion Criteria:

* Psychotic state,
* Under the age of 18,
* Not qualified to answer the questions,
* Don't speak any Hebrew at all.
Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia

Recently in 2016, a new interfascial plane nerve block was developed for thoracic analgesia known as the erector spinae plane block (ESPB). Since its development for thoracic neuropathic pain, the ESPB has been shown to be effective in pain control in multiple procedures including thoracotomies. However, there have been a few published case reports of using ESPB for analgesia in rib fracture management and only one retrospective study which demonstrated improved NRS pain scores and increased incentive spirometry volumes (ICV) post-ESPB compared to pre-ESPB values.

The goal of this study is to compare the effectiveness of ESPB as an alternative method to the current standard of care at Stanford Health Care (SHC) for pain management in traumatic rib fractures. At the investigator's institution, the current standard of care is intravenous (IV) and enteral multimodal analgesia that consists primarily of opioids and a continuous IV lidocaine infusion. Although IV lidocaine has shown some benefit in improving post-surgical pain scores, evidence for its use in MRF is lacking. The purpose of this study is to perform a randomized clinical trial comparing outcomes in pain control and incentive spirometry volumes between continuous ESPB catheters and IV lidocaine infusions in adult patients with acute traumatic rib fractures.

The investigators want to determine if ESPB can provide improved pain control in patients admitted for traumatic rib fractures compared to IV Lidocaine. The aim is to evaluate the clinical effectiveness of ESPB on OME consumption, pain scores, incentive spirometry volumes, cough strength, respiratory complications, inflammatory biomarkers and hospital LOS. Findings from this study can help improve analgesia, quality of care, and patient satisfaction at Stanford Healthcare and for other acute pain and trauma surgery providers.

The aim of this study involves pain management for patients with acute traumatic rib fractures and therefore must involve human subjects.


Eligibility Criteria:
Inclusion Criteria:

- All adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures.

Exclusion Criteria:

* Hemodynamically instability,
* Mechanical ventilation,
* Polytrauma (defined as bone or organ injury outside the thorax),
* Pregnancy,
* Incarceration
* Local anesthetic allergy or contraindications to lidocaine (Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular block)
* Chronic opioid use.
Clinical Implication of DAC (Detrusor After-contraction)

The aims of this study are

* to confirm whether detrusor after-contraction (DAC) is a true contraction or not with a new approach
* and to understand clinical implication of DAC

The definition of detrusor after-contraction (DAC) is usually accepted as the increase of detrusor pressure (Pdet), whether it is sudden or not, after cessation of urinary flow. The amount of increase in Pdet is sometimes included in the definition of DAC (14, 15, 20 cmH2O or at least two times the level of the maximal Pdet during the voiding phase). However, it is clear that the lack of a well-established definition may induce much bias in the interpretation of the clinical implication of DAC. The previous studies showed a wide range of prevalence.1-4 DAC seemed to occur more frequently in children and the occurrence rate usually decreased with age in urodynamic studies.

Eligibility Criteria:
Inclusion Criteria:

* Indications and selection of patients for conduction of urodynamic studies (UDS) were followed as the recommendation of ICS (international continence society).

Exclusion Criteria:

* Patients with indwelling catheters, urinary tract infection and urinary stones were excluded from this study
A Study of ZN-c3 and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer

This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib and of ZN-c3 Monotherapy in subjects with platinum-resistant ovarian cancer.

This is a Phase 1/2 open-label, multicenter study to evaluate the safety, clinical activity, PK, and PD of ZN-c3 in combination with niraparib and of ZN-c3 Monotherapy in subjects with platinum-resistant ovarian cancer who have failed Poly (ADP-ribose) polymerase inhibitor (PARPi) maintenance treatment.

Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically or cytologically confirmed recurrent high grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with histologic subtypes of serous, clear cell or endometroid for which there is no known or established treatment available with curative intent.
2. Subjects must have platinum-resistant disease.
3. Must have evaluable or measurable disease according to RECIST v1.1 criterion: defined as at least one lesion that can be accurately measured.
4. Adequate hematologic and organ function.
5. Ability and willingness to take oral medication.
6. Subjects must provide formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer.

Key Exclusion Criteria:

1. Prior therapy directed at the malignant tumor within the last four weeks prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C).
2. A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required.
3. Any investigational drug therapy \<28 days.
4. Prior treatment with a WEE1 inhibitor.
5. Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or its excipients.
6. Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
7. Uncontrolled hypertension (Diastolic BP \> 90 mmHg or Systolic BP \> 140 mmHg).
8. Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV).
9. Significant gastrointestinal abnormalities, requirement for IV alimentation, active peptic ulcer, chronic diarrhea, or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.
10. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of \>480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
11. History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP).
12. Taking medications with a known risk of TdP (according to current information provided at https://crediblemeds.org).
Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running

The objective of the study is to determine whether five days of ginger (Zingiber officinale) supplementation is effective at reducing muscle soreness and improving muscle function following downhill running. Long-distance running is often associated with acute muscle pain, swelling, and reduced muscle functioning, and consequently, many runners utilize non-steroidal anti-inflammatory drugs (NSAID). NSAID use is associated with gastrointestinal side-effects such as stomach discomfort, nausea, dyspepsia, asymptomatic ulcers, and symptomatic ulcers that, although rare, can be fatal. Ginger is a botanical compound that is Generally Recognized as Safe by the Food and Drug Administration (FDA). Evidence from osteoarthritis, dysmenorrhea, and resistance-training models indicate that ginger is effective at reducing general pain and muscle soreness. Therefore, this study will supplement 60 runners with roughly 1.5 g/day of ginger root or a placebo for 2 days prior to, the day of, and 2 days after downhill running. Participants will be evaluated for muscle soreness and function before and after the downhill run.


Eligibility Criteria:
Inclusion Criteria:

* Be currently running ≥10 miles per week
* Have completed at least one run \>40 minutes over the past month

Exclusion Criteria:

* Have no allergies to ginger
* Willing to avoid pain-relieving medications for the duration of the study
* Have no history of bleeding disorders nor currently taking blood thinners