cyrilzakka/clinical-trials huggingface dataset:
Germ Cell Tumor and Testicular Tumor DNA Registry

This study is being done to create a registry to help us learn more about germ cell tumors (GCT) and other testicular tumors. The registry will include people with these tumors and also relatives and unrelated people without these tumors. This study will help us learn more about the prevention, diagnosis, treatment and outcome of these tumors. Studying relatives of patients and people unrelated to patients with GCT and other testicular tumors will help us understand why some people get these tumors and why some people don't.


Eligibility Criteria:
Inclusion Criteria:

Case Cohort

* Must be ≥ 18 years of age AND
* Must be an English-speaker AND
* Must have a diagnosis or suspicion of germ cell tumor and/or a testicular mass

Family Member Cohort

* Must be ≥ 18 years of age AND
* Must be an English-speaker AND
* Must be a blood relative of the proband. Family members of probands are eligible. These individuals need not have a diagnosis of GCT-TT, as they will be used for segregation analysis of suspected variants found in the proband.

Control Cohort

* Must be ≥ 18 years of age AND
* Must be an English-speaker AND
* Must not have a personal history of cancer, with the exception of non-melanoma skin cancer, AND
* Must not have a family history of germ cell tumor or testicular tumor AND
* Must not be a blood relative of controls enrolled in this study

Exclusion Criteria:
: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)

the goal of the study is to improve the quality of life of patients on antipsychotic medications and increase the rate of compliance to treatment.

Primary objective:

1.To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.

Secondary objective:

1. To determine the effect of probiotic supplementation on the psychological state of patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult schizophrenia patients (18-45 years) on second generation antipsychotics Stable patients with a total positive and negative syndrome scale (PANSS) score of ≤60.

With more than 10% weight gain after taking atypical antipsychotics for at least 3 months with treatment duration not more than two years.

Exclusion Criteria:

1. Taking probiotics, fiber supplements, antibiotics and laxatives in the last 6 weeks.
2. Comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled and recurrent diarrhea, gastrointestinal bleeding, and digestive system neoplastic diseases.

   -
A Study of SHR-A1904 in Patients With Advanced Solid Cancer

The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with advanced solid cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904


Eligibility Criteria:
Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
2. Males or females aged 18-75 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
4. Has a life expectancy≥ 3 months
5. Has at least one measurable lesion as defined by RECIST v1.1
6. Pathologically confirmed advanced solid cancer

Exclusion Criteria:

1. Plan to receive any other anti-tumor treatments during the study treatment period of this study
2. Received other clinical investigational products or treatments within 4 weeks before the first dose of the study
3. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
4. Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study
5. Subjects with known brain metastases
6. Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the study
7. presence of accompanying diseases (such as poorly controlled hypertension, serious diabetes mellitus, thyroid disorder, psychosis, etc.) that may pose serious risks to the safety of the subject or may affect the subject's ability to complete the study, or any other situation as judged by the investigator
Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body.

Patients receive up to 8 weeks of two or more anti-tuberculosis drugs, of which at least two are isoniazid, rifampin, pyrazinamide, or ethambutol. Blood specimens are collected at 2, 6, and 10 hours after administration of study medication, once between Days 10 and 14 of a phase of daily treatment and once while on an intermittent dose regimen (twice weekly or three times weekly).

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive and have tuberculosis.
* Are 13 years of age or older.
* Have written, informed consent of parent or guardian if you are under 18 years of age.
* Agree to practice abstinence or use barrier methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have any other disorder or condition which might cause study treatment to be undesirable.
* Are pregnant.
Optic Nerve Sheath Diameter in Pediatric Patients

Endotracheal intubation and laryngeal mask are generally applied to secure the airway during general anesthesia. There is a widespread opinion among anesthesiologists that endotracheal intubation increases intracranial pressure. Since there were no non-invasive methods measuring intracranial pressure in the past, adequate studies on this subject could not be done. With this measurement, we aimed to show whether ETT or LMA applications have effects on intracranial pressure.

In normal pediatric patients with closed fontanelles, the contents of the central nervous system are almost compressed into the skull and spinal canal. Intracranial pressure is created and constant by the total volume of brain, CSF, and blood within the skull. Increased intracranial pressure can be measured with an intraventricular catheter, transducers, and a subarachnoid bolt. By measuring the diameter of the optic nerve sheath with ultrasonography, we can find out whether there is an increase in intracranial pressure non-invasively.

Endotracheal intubation and laryngeal mask are generally applied to secure the airway during general anesthesia. There is a widespread opinion among anesthesiologists that endotracheal intubation increases intracranial pressure. Since there were no non-invasive methods measuring intracranial pressure in the past, adequate studies on this subject could not be done. With this measurement, we aimed to show whether ETT or LMA applications have effects on intracranial pressure.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 2-18 years
2. Patients undergoing general anesthesia
3. Patients who agreed to be included
4. ASA I-III

Exclusion Criteria:

1. Those with any eye pathology
2. Those with intracranial pathology
Nucleotide Polymorphism in ARDS Outcome

Acute respiratory distress syndrome (ARDS) is characterized by increased pulmonary vascular permeability and reduced aerated lung tissue. With an extremely high hospital mortality among 35 - 46%, current therapeutic strategies to increase ARDS survival are still limited. Advances in etiology and pathology of ARDS are urging. Numerous genetic variants were identified associated with ARDS outcome. By whole-exome sequencing association study, our goal was to explore the associations between genetic variants and ARDS outcome.

Acute respiratory distress syndrome (ARDS) is characterized by increased pulmonary vascular permeability and reduced aerated lung tissue. With an extremely high hospital mortality among 35 - 46%, current therapeutic strategies to increase ARDS survival are still limited. Advances in etiology and pathology of ARDS are urging. Numerous genetic variants were identified associated with ARDS outcome. Then a few genetic risk factors have been discovered by large-scale genotyping approaches, from in vivo or in vitro models of lung injury, which highlight the importance of identifying genetic biomarkers of ARDS outcome to further improve stratification. The mutational landscape and variability at single nucleotide polymorphisms (SNP) with ARDS outcome in Chinese is unknown, not to mention their associations. By whole-exome sequencing association study, our goal was to explore the associations between genetic variants and ARDS outcome.

Eligibility Criteria:
Inclusion Criteria:

Adult ARDS (according to Berlin definition) patients were enrolled in the trial.

The diagnostic criteria included

1. within one week of a known clinical insult or new or worsening respiratory symptoms;
2. chest imaging showing that bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules;
3. respiratory failure not fully explained by cardiac failure or fluid overload;
4. arterial partial pressure of oxygen / fraction of inspiration oxygen (PaO2/FiO2 ratio, P/F ratio) less than or equal to 300 mmHg.

Exclusion criteria:

Patients refused to participate in the study.
Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke

The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to determine whether SUN13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects.


Eligibility Criteria:
Each subject must meet all of the following criteria to participate in the study:

1. Male or female subjects between 18 and 85 years, inclusive
2. Subjects with no prior history of stroke (unless the stroke was not associated with a motor deficit)
3. Subjects must score at least 16 points on the standard MMSE during baseline assessments
4. Subjects must have a total score between 7 and 30, inclusive, out of 35 on the S-STREAM administered between 24 and 48 hours after the onset of acute stroke
5. Subjects must have an estimated pre-stroke mRS of 0 or 1
6. Male subjects agree to be heterosexually abstinent or use appropriate contraception
7. Female subjects must have undergone menopause or, if premenopausal, must have a negative pregnancy test at baseline. Female subjects of childbearing potential agree to be sexually abstinent or must be willing to utilize adequate contraception
8. Subjects must be willing to provide verbal/nonverbal informed consent indicating voluntary consent to participate in the study (if a subject is unable to provide informed consent, but able to comply with other study procedures, the subject's LAR may provide consent)

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

1. Prior exposure to SUN13837
2. History of severe allergic reaction, whether explained or not, requiring a visit to the ER and/or medical intervention with epinephrine
3. Development of hemodynamic instability following the acute stroke
4. History of dementia, advanced Parkinson's disease, other significant movement disorders, or other clinically significant diseases which would jeopardize the safety of the subject or impact the validity of the study results
5. Presence of significant global or receptive aphasia
6. Presence of clinically significant abnormal laboratory values at the time of presentation in the ER
7. History of malabsorption or any gastrointestinal abnormality that could impair oral absorption
8. Finding of Grade 3 or 4 proliferative retinopathy on routine fundoscopic examination or history of proliferative retinopathy (Grade 3 or 4) in subjects with diabetes mellitus
9. Unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome (CYP) P450 3A4/5 inhibitors, potent CYP2D6 inhibitors, CYP3A inducers, or potent P glycoprotein (P gp) inhibitors
10. Current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of acute stroke onset
Raltegravir and Atazanavir Replacing Current Suppressive Treatment Because of Side Effects in Current Treatment

Subjects with HIV who have viral suppression on current regimen but also have side effects/intolerance will change their current regimen to a combination of Raltegravir and Atazanavir and be monitored for viral and immunological response and quality of life.

Subjects with intolerance to current regimen will receive Raltegravir 400 mg twice daily and Atazanavir 400 mg daily will be monitored for viralogical and immunological outcomes, changes in lipids, renal and hepatic safety and quality of life.

Eligibility Criteria:
Inclusion Criteria

* History of no PI resistance or antiretroviral failure while receiving a PI.
* On a current antiviral regimen with plasma HIV viral load (VL) \< 400 copies/ml for 4 months or longer.
* Intolerance to or toxicity with current or alternative regimen(s) with side effects including but not limited to gastrointestinal, neurological, metabolic, or dysmorphic symptoms and/or dyslipidemia.
* Continuously using the same regimen for 3 months prior to Screening.
* Women of childbearing potential must be willing to use effective method(s) of contraception throughout their study participation and for 30 days following the end of the study (see Section 1.10). -Women who are postmenopausal for at least 2 years, women with total hysterectomy and women with tubal ligation are considered of non-childbearing potential.
* Willing to adhere to the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

* Use of any drug contraindicated in the current US package insert for Atazanavir or in the investigators brochure for Raltegravir, including PPI inhibitors.
* Use of any investigational drug up to 4 weeks prior to screening.
* Prior or current therapy with Raltegravir.
* Allergy to Raltegravir or Atazanavir
* History of medication non-compliance significant to the study regimen as deemed significant by the investigator.
* Known achlorhydria that would inhibit the absorption of Atazanavir
* Concurrent active chronic Hepatitis B requiring therapy with 3TC, FTC or Tenofovir (entecavir permitted).
* AST or ALT \>5 times ULN
* Calculated CrCl \< 30 ml/min.
* Female subject who is pregnant or breastfeeding.
* General medical condition that may interfere with the assessments and completion of the trial.
Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients

It is well known that ICU patients need sedation. Now no ideal sedation drug existed and every sedation drug has its advantage and disadvantage,so combined sedation may use the advantage and avoid the disadvantage of the sedation drug according to the patients'condition. Until now, there is rare study about the combined sedation or sequenced sedation of different sedation drug.The purpose of the study is to explore the value of combined sedation with midazolam and dexmedetomidine compared to single drug sedation in ICU, so as to seek an ideal sedation protocol that could reduce the cost of treatment,obtain the appropriate sedation not under sedation or over sedation,reduce the incidence of delirium, reduce the adverse event of sedation.


Eligibility Criteria:
Inclusion Criteria:

1. ICU patients needing sedation
2. 18 years or older
3. mechanically ventilated for less than 96 hours prior to start of study drug.

Exclusion Criteria:

1. Trauma and burn patients as admitting diagnosis.
2. Dialysis of all types.
3. Pregnant or lactation.
4. Neuromuscular blockade other than for intubation.
5. Epidural or spinal analgesia.
6. General anesthesia prior to or planned after the start of study drug infusion
7. Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia).
8. Acute hepatitis or severe liver disease (Child-Pugh class C).
9. Unstable angina or acute myocardial infarction.
10. Left ventricular ejection fraction less than 30%,heart rate less than 50/min. 11.Second or third degree heart block.

12.Allergy to the study drug. 13.Systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.

14. Patients with renal insufficiency were randomized and treated; however, patients were discontinued if they required dialysis.
Characteristics of Tuberculosis Infection in Rheumatic Disease

A retrospective study evaluating the characteristics of tuberculosis infection in patients of rheumatic disease.


Eligibility Criteria:
Inclusion Criteria:

* The patients with International Classification of Diseases (ICD) codes of rheumatic diseases during 2006-2017
* Definite evidence of tuberculosis infection

Exclusion Criteria:

* HIV, malignancy, not follow-up rheumatic disease in National Taiwan University Hospital, younger than 20-year-old, refusing attend research
Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)

The purpose of this research study is to evaluate whether the combination of Shockwave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function in diabetics patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Between 30 to 80 years of age (inclusive).
3. Be able to provide written informed consent.
4. Have a diagnosis of Mild to Moderate ED (12-21) or Mild ED (22-25) based on International Index of Erectile Dysfunction - Erectile Function (IIEF-EF) questionnaire score.
5. Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history of Hemoglobin A1C \> 7% OR on medical therapy for Diabetes.
6. Be in a stable relationship and have a minimum of 2 sexual attempts per month for at least one month prior to enrollment.
7. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
2. Previous history of priapism, penile fracture, Peyronie's Disease, or penile curvature that negatively influences sexual activity.
3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%).
4. Psychogenic ED as determined by study investigator.
5. Patients using Intracavernous Injections (ICI) for management of ED.
6. Patients with generalized polyneuropathy, neurological conditions, or psychiatric disease (such as bipolar disorder or depression).
7. Have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
8. History of consistent treatment failure with Phosphodiesterase 5 (PDE5) inhibitors for therapy of ED.
9. Poorly controlled diabetes as indicated by Hemoglobin a1c \> 7.5%.
10. Use of antiplatelet medications
Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients

The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with identical radiation treatment technique and parameters. After the two setups have been planned, the treating faculty reviews the setups and will choose the setup he feels that will give the patient improved dosimetry to the local regions and hopefully reduce toxicity and improve treatment tolerability.

This is a study of two different setups when treating a patient with standard of care radiation doses. The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with identical radiation treatment technique and parameters. After the two setups have been planned, the treating faculty reviews the setups and will choose the setup he feels that will give the patient improved dosimetry to the local regions and hopefully reduce toxicity and improve treatment tolerability.

Patients will not be randomized or stratified by demographic or disease risk assessment, but treatment will be tailored to stage specific current standards of care.

An extra (non standard of care) CT is required to analyze the data.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven anal cancer (squamous, basaloid, or cloacogenic carcinoma) or distal rectal cancer (adenocarcinoma variants) that traverse the dentate line and are eligible for definitive chemoradiation or preoperative radiation therapy, respectively.
* Any histological grade.
* Age: \>18 years.
* Gender: Male patients with average external genitalia.
* Race: Any.
* Language: English speaking only.
* Performance status: Good (Karnofsky Performance Status of \>60%). (ECOG 0-2).
* UTMB patients
* Stages: Early local disease to locoregionally advanced disease per the 2002 American Joint Committee on Cancer (AJCC) Staging System.
* Anal Cancer: Stages I-IIIB (see Section 11).
* Distal Rectal Cancers that pass the dentate line and into the anal canal only: Stages IIA-IIIC (see Section 11).

Exclusion Criteria

* Histological variants other than those listed above in 4.a.
* Patients with cystocele or abnormal scrotal edema will be excluded. (Although the Genital Drop Technique may specifically benefit this group of patients, however this study is to be performed with average patient anatomy).
* 2002 American Joint Committee on Cancer (AJCC) Staging System. (Anal Cancer: Stage IV.; Distal Rectal Cancer: Stage IV, and tumor 2-node 0-metastasis 0 (T1-T2N0M0) patients).
* Performance status: Poor (Karnofsky Performance Status of \<60%). (ECOG 3-4).
* Non-English speaking patients.
* Prior pelvic radiation.
* Prior pelvic malignancy.
* Anal cancer/rectal cancer surgery, except for biopsy at study site.
* Patient's mental condition and social support is such that he can neither understand the nature of the protocol nor comply with its requirements.
Accuracy of Extra-oral Bite-wing Radiography in Detecting Calculus and Crestal Bone Loss

To compare the diagnostic accuracy of extra-oral x-rays with intra-oral x-rays, in contrast to clinically observed measurements, for the detection of calculus and bone loss of either the suprabony or infrabony types in patients undergoing periodontal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be active patients of record at CU School of Dental Medicine
* Patients will have an active treatment plan for periodontal open flap surgery
* Patients will be classified as either ASA I or ASA II
* Patients must have periodontal probing depths \>/= 5mm and radiographic sings of marginal bone loss (supra or infra bony)

Exclusion Criteria:

* Less than 18 years of age
* ASA III or above
* Emergency patients
* Pregnant patients
* Patients who are not patients of record at the CU School of Dental Medicine
* Patients with a recent panoramic radiograph that contraindicates the need for new imaging in the form of extra-oral bitewings