cyrilzakka/clinical-trials huggingface dataset:
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Hodgkin's lymphoma or Non-Hodgkin's lymphoma receiving Q14, Q21, or Q28 day CHOP, ICE, ESHAP, or DHAP chemotherapy; with or without Rituximab
* Has adequate bone marrow function; platelet count \> 100 x 10\^9/L on the day of initiation of the on study chemotherapy of the next treatment cycle and absolute neutrophil count, ANC \> or = 1 x 10\^9/L, and hemoglobin \> or = 9.5 g/dL
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has adequate liver function
* must be able to receive the same chemotherapy regimen during the first treatment cycle as was received during the prior qualifying cycle
* must experience Common Terminology Criteria (CTC) grade 3 or 4 thrombocytopenia (platelet count \< 50 x 10\^9/L) as a result of the chemotherapy administered in the cycle immediately preceding study entry
* has serum creatinine concentration \< or = 2 mg/dl

Exclusion Criteria:

* More that 1 prior relapse chemotherapy regimen
* Sepsis, disseminated coagulation or any other condition that may exacerbate thrombocytopenia
* Significant bleeding (CTC grade 3 or 4)
* History of thromboembolic disease
* Subjects who are identified by clinical history and/or serological testing to have either acute or chronic hepatitis B or C infection or to be HIV positive
* Use of any nitrosourea or mitomycin-C
* Has received any thrombocytopenic growth factor
* Has received a marrow or peripheral blood stem cell infusion
* Known hypersensitivity to any recombinant E. coli-derived product
Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, age 18 years or older on day of signing consent
2. Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
3. Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
4. Life expectancy \> 12 weeks
5. Eastern Cooperative Oncology Group (ECOG) performance status:

   * Part 1: 0 or 1
   * Part 2 and 3: 0, 1, or 2

Exclusion Criteria:

1. Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
2. Prior receipt of a selective FGFR inhibitor
3. History of a calcium/phosphate homeostasis disorder
4. History and/or current evidence of ectopic mineralization/calcification
5. Current evidence of corneal disorder/keratopathy
6. Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
7. Prior radiotherapy within 2 weeks of study treatment
The Peer-Based Retention of People Who Use Drugs in Rural Research

The purpose of this study is to, through several aims, test the effectiveness of peer-driven intervention and inform methods to optimize engagement in research in people who use drugs (PWUD) in rural America.

This study builds on the National Rural Opioids Initiative (NROI), a multi-state consortium studying access to care, overdose, and infectious consequences of opioid use disorder (OUD) in Rural America. It includes counties in rural Oregon and Appalachian Kentucky and Ohio with high rates of drug overdose.

Aim 1: Conduct a randomized trial to evaluate the effectiveness of a peer-driven study retention intervention for retaining PWUD in Kentucky, Ohio, and Oregon Rural Opioid Initiative sites.

Aim 2: Elicit preferences of PWUD in the Kentucky, Ohio, and Oregon Rural Opioid Initiative sites Aim 2a: Administer baseline survey of discrete choice experiment preferences for participating in clinical trials of potential medical innovations (e.g. new treatments for OUD, HIV, and HCV vaccination). Aim 2a will be accomplished as part of the NROI studies. The data will then be merged for PROUD-R² analyses.

Aim 2b: Compare participant survey preferences regarding willingness to participate in clinical trials at baseline, 6, and 12 months.

Aim 3: Explore participant perceptions of clinical research participation and retention among PWUD in rural America.

Eligibility Criteria:
Inclusion Criteria:

NROI eligibility criteria: Participants are eligible to enroll in the NROI if they 1) live in the study area, 2) have recently injected drugs or report opioid use to get high without injection, and 3) are age 18 or older.

NROI participants enrolled after April 2019 are eligible to participate in the PROUD R2 study.

Participants enrolling as study buddies will be eligible if they 1) live in the study area, 2) are age 18 or older; they do not need to have recent or past substance use to qualify.

No eligible participants are excluded.

Exclusion Criteria:

Under 18 years of age
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome

To evaluate the effectiveness of rhGH (Recombinant human growth hormone) injection for improving motor development in patients with PWS.


Eligibility Criteria:
Inclusion Criteria:

* 1.Signed informed consent from legal guardian of the subjects;
* Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures;
* Diagnosed as PWS by gene test;
* Age: 1 month (30 days after birth) - 5 years of age;
* Male or female;
* Calculated by Peabody Developmental Motor Scale, total motor quotient, gross motor quotient or fine motor quotient is less than 90 points;
* Thyroid function is within the normal reference range or remained within the normal reference range by substitution therapy;
* No history of rhGH therapy before.

Exclusion Criteria:

* Subjects with abnormal liver or kidney function;
* Subjects with obvious central sleep apnea and/or moderate or severe obstructive sleep apnea, acute lung infection;
* Subjects with chronic diseases that have long-term effects on bone metabolism and body composition;
* Subjects with congenital skeletal dysplasia, or spine scoliosis with moderate and above degree requiring treatment or lameness;
* Subjects with history of congenital heart disease, or an echocardiogram showing that the structural abnormalities require surgery or interventional therapy or that the left ventricular ejection fraction is \<40%, or the abnormal electrocardiogram requiring intervention;
* Subjects with history of convulsions or epilepsy;
* Subjects with other systemic chronic diseases;
* Subjects with diagnosed tumors;
* Subjects with family history of cancers, a previous history of cancer, or considered to be a high risk of cancer combinating other information;
* Subjects with mental disease;
* Subjects with diabetes, or abnormal fasting glucose and researchers believe that may affect the safety of the subject;
* Subjects with severe obesity;
* Subjects with highly allergic constitution or allergy to proteins or investigational product or its excipient;
* Subjects who took part in other clinical trials within 3 months ;
* Subjects who received drug treatment that may interfere with GH secretion or GH action within 3 months;
* Other conditions in which the investigator preclude enrollment into the study
Evaluation of Biological Response to SARS-COV2 (COVID-19) in Patients With Pre-existing Neurological Disease or Newly Neurological Symptoms (BIO-COCO-NEUROSCIENCES)

Patients with neurological or psychiatric symptoms or pre-existing disease will be sampled (blood for serum and DNA or saliva for DNA) at inclusion and at M6 (blood) and M12 (blood) depending on their pathology. Sampling will be done either at hospital if patient is on site for routine care or at home if no consultation is scheduled at hospital.


Eligibility Criteria:
1. Age over 18 yo
2. Patient having presented or presenting a Covid-19 infection defined by a positive PCR or a typical chest scanner of Covid-19 infection or a positive serology or a typical clinical picture in a pandemic period
3. And patient with:

   1. a neurological or psychiatric manifestation de novo during or after the Covid-19 infection and/or
   2. either a chronic neurological or psychiatric pathology
Retrospective Study of Long-Term Survival of "Immuncell-LC" in Patients Undergoing Curative Resection for HCC in Korea

To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular carcinoma in Korea

The purpose of this study is to retrospectively compare the long-term survival of patients who participated in the "Randomized, open-label, multicenter phase 3 clinical trial to evaluate the efficacy and safety of Immunocel-LC treatment and no treatment in Korean patients with hepatocellular carcinoma (HCC) who received potentially curative treatment \[surgical resection, radiofrequency ablation (RFA), or percutaneous ethanol injection (PEI)\] (NCT00699816). HCC was diagnosed by pathological evaluation or radiological imaging studies. Eligibility criteria also included hepatic function of Child-Pugh class A and an Eastern Cooperative Oncology Group performance status score of 0 or 1. Exclusion criteria included autoimmune disease or immunodeficiency, previous or current malignant tumor other than HCC, and severe allergic disorders. Pregnant or breastfeeding women and women planning to become pregnant were also excluded. All eligible participants were randomly assigned to receive adjuvant immunotherapy using a CIK cell agent (the immunotherapy group) or no adjuvant treatment (control group) in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Patients of participated in the(ClinicalTrials.gov Identifier:NCT00699816)clinical trial.

Exclusion Criteria:

* NA
A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis

To determine the safety and effectiveness of intravenous ganciclovir (also known as DHPG) in the treatment of sight-threatening cytomegalovirus (CMV) retinitis in patients with AIDS. CMV retinitis is a severe vision-threatening viral infection of the retina of the eye. It occurs in patients whose immune function has been impaired and is the most common cause of blindness in patients with AIDS. Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis in approximately 80 percent of the patients treated for 2 weeks, but almost all of the patients treated with GCV had a relapse after treatment was stopped. Thus, it is important to determine if GCV can be safely given over a long period of time (maintenance therapy) and if it is effective in preventing a relapse of CMV retinitis.

CMV retinitis is a severe vision-threatening viral infection of the retina of the eye. It occurs in patients whose immune function has been impaired and is the most common cause of blindness in patients with AIDS. Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis in approximately 80 percent of the patients treated for 2 weeks, but almost all of the patients treated with GCV had a relapse after treatment was stopped. Thus, it is important to determine if GCV can be safely given over a long period of time (maintenance therapy) and if it is effective in preventing a relapse of CMV retinitis.

Patients are given GCV intravenously for 14 days. Then the patient receives the same dose, but only once a day, for as long as therapy is tolerated. If the retinitis worsens during the maintenance phase, the patient may again be given GCV for 14 days. Long-term treatment with GCV usually requires the surgical placement of a catheter in a large central vein in the chest or groin that is left in place indefinitely. If this is required, the procedure will be explained to the patient.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia.
* Topical ophthalmics.
* Topical acyclovir.

Concurrent Treatment:

Allowed:

* Hemodialysis for patients with renal impairment.

Patients must have:

* Diagnosis of AIDS and immediately sight-threatening cytomegalovirus retinitis.

Prior Medication:

Allowed:

* Zidovudine.
* Prior therapy for retinitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Non-immediately sight-threatening cytomegalovirus retinitis.

Concurrent Medication:

Excluded:

* Systemic investigational agents such as antimetabolites, alkylating agents, nucleoside analogs, acyclovir sodium (Zovirax).
* Interferon.
* Cytokines.
* Foscarnet (non-nucleoside pyrophosphate analog).
* Ganciclovir may be withheld for up to 21 days for an acute course with an investigational or toxic therapy or oral / IV acyclovir.

Patients with the following are excluded:

* Non-immediately sight-threatening cytomegalovirus retinitis.
Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion

This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger clinical trial in a patient population requiring spinal fusion.


Eligibility Criteria:
Inclusion Criteria:

* Subject has radiographically documented spinal degeneration with instability as documented by the presence of translation \>= 4mm or angulation \>= 5°.
* Subject has intractable back pain which does not respond to conservative treatment and in the investigator's opinion, requires surgical spinal fusion.
* Subject's pain is predominantly associated with the back.
* Subject has only one level involvement at L3-L4, L4-L5, or L5-S1.
* Subject is 18 years of age or greater at the time consent is given to participate in the study.
* Subject is willing to comply with the study plan and sign the informed consent.
* Subject is male or a non-pregnant, non-nursing female. All females of child-bearing age must agree to use adequate contraception for a period of no less than 16 weeks following surgery.

Exclusion Criteria:

* Subject has primary spinal diagnosis of a disorder other than spinal degeneration with instability at the involved surgical level.
* Subject has spinal stenosis or condition which requires a full laminectomy procedure.
* Subject has had a previous fusion, discectomy or laminectomy procedure at L3-L4, L4-L5 or L5-S1.
* Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids, methotrexate) or has a condition which requires postoperative medications that interfere with fusion (e.g., steroids, nonsteroidal antiinflammatory drugs, or methotrexate).
* Subject has overt or active infection near the operative spinal region.
* Subject has active systemic infection.
* Subject has history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
* Subject's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
* Subject has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/BCP implantation.
* The subject requires electrical bone growth stimulation, allograft, or bone substitute as part of treatment.
* Subject has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers Danlos syndrome, or osteogenesis imperfecta).
* Subject has a known diagnosis of diabetes which requires treatment with medication.
* Subject has received previous radiation therapy at the site to be fused.
* Subject is unwilling to return for required follow-up visits.
* Subject is a prisoner.
* Subject has insufficient bone mass which precludes surgery (e.g., severe osteopenia or osteoporosis).
Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination

The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given in individual doses, according to a nomogram we have constructed based on our results from a previous study, results in more patients maturing 2-3 follicles compared to standard dose.


Eligibility Criteria:
Inclusion Criteria:

* Age between 25-39 years
* First stimulation with rFSH only
* Indication for intrauterine insemination with standard rFSH starting dose
* Regular menstrual bleeding with a cycle between 21-35 days
* Two ovaries
* Bilateral tuba patency
* Semen analysis must be sufficient for insemination according to the diagnostic analysis.

Exclusion Criteria:

* More than three former stimulated intrauterine insemination cycles
Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients

The aims of this study are to obtain pharmacokinetic data on interactions between dolutegravir (DTG) and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Sirolimus and Mycophenolic acid) in solid organ transplant (SOT) recipients to provide proof of principle data that DTG plus 2 nucleosides (NUCs) is safe and effective in HIV-infected SOT recipients.


Eligibility Criteria:
Inclusion Criteria:

1. HIV patients \>18 years old who provide signed and dated informed consent;
2. Males and females;
3. SOT recipients (heart, liver or kidney);
4. On stable antiretroviral therapy (ART) for ≥6 months preceding the screening visit;
5. Plasma HIV RNA \<50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load \>50 between determinations);
6. Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing

Exclusion Criteria:

1. HIV patients who have stopped ART due to virological failure;
2. HIV patients who require treatment with DTG contraindicated medications;
3. History or presence of an allergy or intolerance to the study drug;
4. Active opportunistic infection;
5. Neoplasms requiring chemotherapy.
6. Pregnancy or breast feeding or planned pregnancy during the study period
7. Any other contraindication to study drugs.
DLCS for Predicting Neoadjuvant Chemotherapy Response

The early noninvasive screening of patients suitable for neoadjuvant chemotherapy (NCT) is essential for personalized treatment in locally advanced gastric cancer (LAGC). The aim of this study was to develop and visualized a radio-clinical biomarker from pretreatment oversampled CT images to predict the response and prognosis to NCT in LAGC patients.


Eligibility Criteria:
Inclusion Criteria:

1) patients with GC/EGJC confirmed by pathological examination; 2) patients who underwent D2 lymphadenectomy; 3) patients who received at least two cycles of preoperative chemotherapy; 4) patients with negative resection margins; and 5) patients with complete CT image data and clinical data.

Exclusion Criteria:

1) patients unable to undergo D2 radical gastrectomy after neoadjuvant therapy; and 2) patients with incomplete CT images and clinical data.
Freezing of Gait - Clinical Outcomes Assessment

To develop a reliable and accurate clinician-reported outcome (ClinRO) measure (against a new and precise definition) and patient reported outcome (PRO) for use by clinicians and researchers to quantify the severity of Freezing of Gait (FOG).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease (PD) made by a neurologist according to the Movement Disorders Society guidelines;
2. Able to walk independently for a distance of 10 meters, without walking aid;
3. Absence of a Deep Brain Stimulator;
4. Stable PD treatment in the 4 weeks prior to participation that is not expected to change in the course of the study.
5. For patients with FOG: a score of ≥ 1 on the New Freezing Of Gait Questionnaire (NFOG-Q).

Exclusion Criteria:

1. Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class \>3), acute psychosis or major psychiatric disorders or continued substance abuse, other neurological (than PD) or orthopaedic impairment that significantly impacts on gait.
2. Unwilling to temporarily delay the morning anti-Parkinsonian medication.
3. Preganacy and
Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009g

The primary objective of the study is to assess the relationship (both crude and adjusted) between voriconazole utilization and the development of non-melanoma skin cancer among adult patients who received a lung or heart/lung transplant and were continuously enrolled in a large U.S. commercial health plan.

N/A. All patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database were sampled.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database will be initially included in the study.

Exclusion Criteria:

* Patients who are younger than 18 years of age and who are not enrolled for at least 180 days before and 180 days after the date of transplant will be excluded.