cyrilzakka/clinical-trials huggingface dataset:
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants

This phase I/II clinical trial is an open-label clinical trial design to verify safety and dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).

Tuberous Sclerosis Complex (TSC) is caused by genetic mutation in TSC1 or TSC2, resulting in dysregulation of the mechanistic target of rapamycin (mTOR) signaling pathway. Age at time of seizure onset in TSC infants has been linked to long-term neurodevelopmental outcome in this high-risk population. TAVT-18 is a novel formulation of sirolimus, an mTOR inhibitor. This study evaluates TAVT-18 as a targeted, disease-modifying drug therapy for preventing or delaying seizure onset in TSC using a rational, mechanism-based therapeutic approach.

Eligibility Criteria:
Inclusion Criteria:

* 0-6 months of age at the time of enrollment (randomization and treatment initiation must occur before 7 months of age and infants born prematurely must have a corrected age of at least 39 weeks, calculated by subtracting the number of weeks born before 40 weeks gestation from the actual chronological age, in weeks)
* Has a confirmed diagnosis of TSC based on established clinical or genetic criteria

Exclusion Criteria:

* Prior history of seizures (clinical or electrographic) at the time of enrollment or identified on baseline EEG
* Has been treated in the past or is currently being treated at the time of enrollment with conventional anticonvulsant medications (AEDs), systemic (oral) mTOR inhibitors (such as rapamycin, sirolimus, or everolimus), ketogenic-related special diet, or another anti-seizure therapeutic agent, device, or procedure
* Has taken any other investigational drug as part of another research study, within 30 days prior to the baseline screening visit
* Has a significant illness or active infection at the time of the baseline screening visit
* Has a history of significant prematurity, defined as gestational age \<30 weeks at the time of delivery, or other significant medical complications at birth or during the neonatal period that other than TSC would convey additional risk of seizures or neurodevelopmental delay (i.e. HIE, severe neonatal infection, major surgery, prolonged ventilatory or other life-saving supportive care or procedures)
* Abnormal laboratory values at baseline (i.e., renal function, liver function, or bone marrow production) that are in the opinion of the investigator clinically significant and may jeopardize the safety of the study subject
* Prior, planned or anticipated neurosurgery within 3 months of the baseline visit
* Has a TSC-associated condition for which mTOR treatment is clinically indicated (i.e. SEGA or AML)
* Subjects who are, in the opinion of the investigator, unable to comply with the requirements of the study
Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer

At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program should fresh embryo transfer (ET) be cancelled?

There is still an ongoing debate on the effect of subtle increased P-hCG concentration on pregnancy outcome after fresh ET. No consensus on the cut-off value to define increased P-hCG seems to exist. It is accepted that high P advances endometrium, leading to asynchrony between the implanting embryo and the endometrium, and resulting in implantation failure. A freeze all embryos policy and postponement of ET in subsequent frozen-thawed cycle has been proposed.

Eligibility Criteria:
Inclusion Criteria:

* Fresh embryo transfer
* Progesterone value on day HCG (Human choriogonadotrophin hormone)

Exclusion Criteria:

* Clinical indication for delaying embryo transfer
Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer

This phase I trial studies how well lorcaserin works in treating chemotherapy-induced peripheral neuropathy in patients with stage I-IV gastrointestinal or breast cancer. Chemotherapy-induced peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. This condition can occur in patients who have received taxane chemotherapy drugs, or the chemotherapy drug oxaliplatin. Lorcaserin may improve chemotherapy-induced peripheral neuropathy by reducing pain, preventing or relieving joint symptoms, and improving balance.

PRIMARY OBJECTIVES:

I. To evaluate preliminary efficacy of lorcaserin to improve balance decrements in patients with chronic chemotherapy-induced peripheral neuropathy (CIPN).

SECONDARY OBJECTIVES:

I. To evaluate patient reported outcomes (PROs) after a one time dose of lorcaserin in patients with chronic CIPN.

OUTLINE:

Patients receive lorcaserin orally (PO) on day 1.

After completion of study treatment, patients are followed for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient with known diagnosis of gastrointestinal (GI) cancer or breast cancer stages I-IV
* Prior exposure to paclitaxel or oxaliplatin within last 24 months
* Have symptomatic CIPN confirmed by self-report, as demonstrated by PRO measure, CIPN-20
* If a female subject is with child bearing potential, she must have a negative pregnancy test at screening
* Female subjects of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after completion of study treatment administration. Adequate contraception includes methods such as oral contraceptives, double barrier method (condom plus spermicide or diaphragm), or abstaining from sexual intercourse
* Be willing and able to understand and sign the written informed consent document

Exclusion Criteria:

* Is beyond 24 months out from completion of oxaliplatin or paclitaxel
* Is asymptomatic for CIPN
* Is currently pregnant or breast feeding as there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lorcaserin
* Has any other medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe for the patient
Treatment of Hematological Malignancy With Novel CAR-T Cells.

This is a single arm, open-label, early phase I study, to determine the safety and efficacy of Novel CAR-T cell therapy in Hematological Malignancy treatment.

The Novel CAR-T contains either a scFv plus a PD-L1 blocker, or two scFvs, in a cytokine complex based outer memberane structure, this kind of structure enables the CAR-T cells to simultaneously target one or two targets on the tumor cell surface and enhance CAR-T cell persistence in tumor microenvironment，as well as stimulating innate T/NK cell activation and expansion.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
2. All subjects must be able to comply with all the scheduled procedures in the study;
3. Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma.
4. Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT;
5. At least one clear indicator for hematological malignancy monitoring;
6. Aged \<70 years;
7. Expected survival ≥12 weeks;
8. Eastern cooperative oncology group (ECOG) performance status of≤3;
9. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
10. All other treatment induced adverse events must have been resolved to

    ≤grade 1;
11. Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB\>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);

Exclusion Criteria:

1. Presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator);
2. Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
3. Lactating women or women of childbearing age who plan to conceive during the investigational time period;
4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
5. Known history of infection with HIV;
6. Subjects need systematic usage of corticosteroid;
7. Subjects need systematic usage of immunosuppressive drug;
8. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
9. Other reasons the investigator consider the patient may not be suitable for the study.
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)

To evaluate changes in renal function, efficacy, and safety when switching from a combination of tenofovir/emtricitabine (TDF/FTC) plus a protease inhibitor/ritonavir (PI/r) to a combination of raltegravir (MK-0518) plus nevirapine plus lamivudine in human immunodeficiency virus (HIV)-1 infected participants with suppressed viremia and impaired renal function.


Eligibility Criteria:
Inclusion Criteria:

* Male, or non-pregnant, non-breastfeeding female
* No previous history of virological failure
* No previous exposure to non-nucleoside reverse transcriptase inhibitors or integrase inhibitors
* No previous history of intolerance to lamivudine
* At least 2 documented plasma HIV-1 RNA \<50 copies/mL and no HIV-1 \>50 copies/mL in the 12 months before screening
* Receiving the same protease inhibitor/ritonavir plus tenofovir/emtricitabine combination for at least the 6 months before screening
* Has no major International Antiviral Society (IAS)-USA mutations on genotype testing performed before starting antiretroviral treatment
* Sexually-active participants and their partners of child-bearing potential agree to use a medically acceptable method of contraception from 2 weeks before Day 1 and for at least 6 months after the last dose of study drug (postmenopausal women are not required to use contraception; sexually-active male participants with a female partner of child-bearing potential must provide written informed consent to information regarding any pregnancy)

Exclusion Criteria:

* Positive for hepatitis B surface antigen (HBsAg+) or anticipated need for hepatitis C virus treatment
* Liver cirrhosis
* Has a history of diabetes mellitus, defined as initiation of antidiabetic treatment or verification of diabetes in a case report form
* Has any cancer, excluding stable Kaposi Sarcoma
* Allergy or sensitivity to the investigational product or excipients
* Female participant who is nursing
* Female participant who is pregnant or intends to become pregnant
* Has an active Acquired Immunodeficiency Syndrome (AIDS)-defining event except stable Kaposi Sarcoma or HIV Wasting Syndrome
* Received any investigational drug within 30 days before screening
* Participated in any other clinical trial within 30 days before signing informed consent for the current trial
Smoking Cessation in Alcoholism Treatment

This study is designed to increase understanding of the processes that affect the treatment outcome of individuals with both alcohol and nicotine dependence. Treatment outcome methodology will be combined with a computerized self-monitoring methodology to examine the extent to which smoking serves as a cue for alcohol craving and/or as a response to alcohol craving in treated alcoholics. Subjects will be veterans participating in the Substance Abuse Day Programs at the Newington and West Haven campuses of the VA Connecticut Healthcare System. Nonveteran women will be recruited from the community and enrolled in the day program. Subjects will be randomly assigned to one of the following two conditions: (1) intensive smoking cessation therapy (counseling plus nicotine replacement using nicotine patches) concurrent with alcohol treatment, or (2) brief smoking cessation advice concurrent with alcohol treatment.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence within the past three months, and criteria for nicotine dependence.
* Smoking at least 10 or more cigarettes per day for the past year.
* Seeking treatment for both alcohol and nicotine dependence.
* Minimum 1 week of alcohol abstinence and substance abuse day treatment attendance.
* Willing to provide names of two individuals who can help locate the subject at follow-up.
* Willing to provide name of one individual who can provide collateral information about alcohol and tobacco use.

Exclusion Criteria:

* Other substance use disorder meeting criteria for dependence.
* Acute medical or psychiatric disorder requiring inpatient treatment.
* Taking medications known to influence alcohol urges (naltrexone, disulfiram).
* Medical problems that would contraindicate nicotine patch use.
* Allergy or hypersensitivity to nicotine or to adhesives used in transdermal delivery systems.
* Use of other nicotine products such as cigars, pipes, or smokeless tobacco.
* Severe generalized skin disorder.
* Myocardial infarction within 3 months prior to study entry.
* Unstable angina.
* Pregnant or lactating females, or females who are not practicing a medically accepted form of contraception.
* Impaired vision or hearing which would interfere with using a hand-held computer.
* Reading ability below fifth grade level.
* Lack of reliable transportation to the treatment site, or living more than 1 hour from treatment site.
* Homeless or unstable residence.
* Plan for future admission to residential treatment.
Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain

* History of clinical breast pain for at least the last six months.
* At least six days of moderate or severe breast pain per cycle.
* Fibrosis, cysts, nodules involving at least 25% of the surface of one breast.
* Euthyroid with no prior history of thyroid disease.
* Six months of daily therapy with molecular iodine.
* Placebo controlled vs active (1:1).

Primary efficacy parameters will be measured by patient self-assessment of pain/tenderness using a categorical daily pain diary. Clinical pain is defined as a patient assessment of moderate or severe pain for any given day. Total clinical pain per menstrual cycle is calculated based upon the categorical ratings recorded in a patient's daily pain diary over the course of a complete menstrual cycle.

A directed breast examination will be used as a secondary efficacy endpoint. Changes in the brest examination will be determined by the physician after consideration of both the nature of the examination findings and the surface area of breast involvement. Changes as noted after six months of therapy, relative to the screening visit (baseline) will be used to evaluate this endpoint.

Eligibility Criteria:
Inclusion Criteria:

* History of clinical breast pain.
* Documentation of 6 or more sequential days of moderate or severe pain by patient daily diary.
* Conservative measures such as local heat, non-prescription analgesics, and properly fitted garments are not effective for the treatment of symptoms
* Euthyroid with no prior history of thyroid disease.
* Premenopausal female between the ages of 18 and 50.
* The presence of at least one palpable structure (nodules, cysts) and involvement (diffuse nodularity or breast thickening) of at least 25% of at least one breast surface.

Exclusion Criteria:

* History of thyroid disease
* Non-cyclic breast pain
* Treatment with gonadotropin releasing hormone (GnRH) agonist, Danocrine, tamoxifen, raloxifene, or bromocriptine within three months of starting the trial
* Initiation or change of any hormonal therapy within 6 months of enrollment; including birth control pills, hormone replacement therapy, any progestin including Norplant or Depo-Provera;
* Current treatment with iodine or iodine-containing medications or diagnostics
* Known hypersensitivity to iodine-containing products
* Breast implants;
* Oophorectomy (complete or partial)
* Uncontrolled hypertension;
* Breast biopsy breast biopsy within two months of screening; or expectation of a breast biopsy during the study for a suspicious mass present at baseline;
* Pregnant women or nursing mothers
* History of malignancy within the previous 5 years other than basal cell or squamous cell carcinoma of the skin
* History of breast cancer
Epidemiological Multicohort Study of Latent COVID-19 Infections

Cross-sectional study to detect latent COVID-19 infections in residents and staff of old people's and nursing homes in the city of Solingen with a prospective follow-up of 6 months in a subgroup.

Particular interest is being paid to old people's and nursing homes during the COVID-19 pandemic, as people at particular risk are to be found there. Therefore, the health department of the city of Solingen will carry out extensive testing of both staff and residents for COVID-19 in this sensitive area. The scientific institute Bethanien für Pneumologie e.V. would like to collect and evaluate the data and test results collected in the process in order to record the occurrence of infections in this area and to obtain information on possible routes of infection and the effectiveness of hygiene measures taken. The aims of the study are:

1. Prevalence of latent COVID-19 infections at one point in time among residents and staff of old people's and nursing homes in Solingen.
2. Prevalence of latent COVID-19 infections over a period of 6 months among staff of a single nursing home (=subgroup)
3. Analysis of transmission pathways of the virus in a nursing home
4. Analysis of the effectiveness of hygiene measures taken
5. Analysis of risk factors (previous illnesses, medication, etc.)

Eligibility Criteria:
Inclusion Criteria:

* informed consent of the test person or the legally authorised guardian

Exclusion Criteria:

* missing consent
Medium-term Venous Access in Congenital Heart Surgery

This study is designed to evaluate medium-term central venous catheter placement in infants undergoing complex cardiac surgery using a new technique. This technique involves placement of the catheter into the inferior vena cava through a subcutaneous tunnel and through a tunnel between pericardium and diaphragm.


Eligibility Criteria:
Inclusion Criteria:

* Infants undergoing surgical correction or palliation of congenital heart disease via sternotomy
* Age 0-365 days
* Anticipated intensive care stay over 10 days
* Need for central venous access or prolonged venous access

Exclusion Criteria:

* Presence of access that is likely to last more than 10 days at time of operation
* Septic shock
* Known inferior vena cava thrombosis
* Operations not approached by sternotomy
Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis

This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Rheumatoid Arthritis Patients

Thisi is a multi-center, double-blind, active-controlled, randomized, parallel-group clinical trial to compare the efficacy and safety of CELBESTA® and CELEBREX® in patients with rheumatoid arthritis. The subject will receive two tablets twice daily for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Anyone over the age of 19
* Subjects who are diagnosed as established rheumatoid arthritis at screening visit and before
* Pain greater than 40/100mm-VAS(Visual Analgue Scale) after wash-out period
* Patients who are taking oral corticosteroids without dosage change (within a range of prednisolone 10mg a day) at least 4weeks and more than 1 DMARDs at least 3 months from screening test
* Patients willing and able to provide signed informed consent after the nature of the study has been explained

Exclusion Criteria:

* History of angina pectoris or congestive heart failure at rest or minimum activity
* History of myocardial infarction or artherosclerosis
* Patients who had a coronary angioplaty or coronary artery bypass graft within 1 year
* History of stroke, transient ischemic attack or hepatitis within 2 years
* Patients who have uncontrolled hypertension at screening
* Patients who take the medicines that might effect the test results by study investigators or might cause a excessive risk to the patients

  * Intra-articular corticosteroid injection within 4 weeks from screening
  * biological DMARDs such as infliximab, adlimumab, entanercept, anakinara or abatacept wihin 6 months from randomization
  * biological DMARDs such as rituximab within 1 year from randomization
* History of a malignant tumor (except for the patients whose tumor was removed and there's no recurrence within 5 years)
* Patients who have gastrointestinal bleeding or peptic ulcer (except scar) within 30 days
* History of a gastroesophageal surgery such as antigastric-secretion surgery or esophagogastrectomy (except a simple perforator surgery)
* Patients who have severe disability in GI, Kidney, Liver and Blood
* Pregnant women, Lactating women and Women of child-bering potential who are not using adequate means of contraception
* History of allergy to COX-2 inhibitors or sulphonamides or other NSAIDs
* Any condition that, in the view of the investigator, would interfere with study participation
Intervention Study of Oral Health Education Programs Directed to Adolescents

This study evaluates behavioral interventions to increase adolescent's motivation for self performed periodontal infection control, by means of adequate oral hygiene. Study subjects will be allocated to test and control group where the test will be subjected to an individually tailored oral health education program, based on cognitive- behavioral theory and principles, and the control to standard educational intervention.

The prevalence of chronic periodontitis is about 40% among the Swedish adult population. The key-factor for the prevention of periodontal disease progression is the establishment of periodontal infection control, by means of adequate daily oral hygiene. Hence, a main task for dental professionals is to educate and motivate the patient to such beneficial behavior. A hypothesis for the current study is that patient centered health promotion programs based on cognitive behavioral theory and principles and with a directive communicative approach, i.e. motivational interviewing techniques, add positive and lasting effects to standard educational interventions on self-performed periodontal infection control.

This randomized clinical field study involves 30 professionals (dental hygienists) and about 350 adolescent patients at 16 dental clinics in the Västra Götaland Region, Sweden. The approach in the evaluation is on patient-centered outcomes and health economics.

Eligibility Criteria:
Inclusion Criteria:

* 16 or 17 years old at inclusion
* poor oral hygiene conditions (dental plaque and/or marginal gingival bleeding at \>50% of tooth surfaces) at the time of examination and thus considered to be at increased risk for oral/periodontal disease progression.

Exclusion Criteria:

* compromised medical or mental conditions that may requiring special care.