cyrilzakka/clinical-trials huggingface dataset:
Events Preceding Interstitial Cystitis (EPIC)

EPIC is a case/control study that seeks to identify the risk factors for interstitial cystitis by comparing the experiences and medical histories of 400 women who recently developed IC with 400 similar people who do not have the disease.

This project is a systematic, national study of incident IC cases and controls matched by age and gender. By telephone interview and medical record review, we compare exposures of cases and controls seeking significant differences which may be risk factors for IC. This cohort of incident IC cases will initiate a natural history study of the disease.

Specific Aim 1. To test the hypothesis that certain features that precede onset of IC symptoms, e.g., bacterial cystitis, distinguish IC cases from controls matched for age and gender, and may be risk factors for the disease.

Specific Aim 2. To test the hypotheses that patients with IC have higher prevalences of certain non bladder syndromes, e.g., irritable bowel syndrome, than do controls matched for age and gender.

Specific Aim 3. To test the hypothesis that urine APF, HB EGF, and/or EGF are sensitive and specific diagnostic markers for IC in patients with symptoms of ÿ12 months.

Specific Aim 4. To test the hypotheses that, in an incident cohort, patients with IC have remissions and that certain clinical features, e.g., bacterial cystitis at disease onset, are prognostic factors for remissions.

Eligibility Criteria:
Inclusion Criteria: Female Adults(18 and over) who have had symotoms of IC for 12 months or fewer

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Exclusion Criteria: Males,children, those who do not have symptoms of IC or those who have had symtoms for greater than 12 months.

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Text Message Quit Vaping Intervention for Young Adults

This research study, conducted by Truth Initiative, will help us learn how text messaging can help young adults between 18 and 24 years of age quit vaping.

The Quit Vaping Study (QVS)'s primary aim is to conduct a fully powered comparative effectiveness trial to evaluate the effectiveness of a quit vaping text message program in promoting abstinence from e-cigarettes among young users aged 18-24. This study is a 2-arm randomized controlled trial conducted among young users aged 18-24 recruited through online channels. Participants will be randomized to a quit vaping text message intervention or to an assessment-only control condition and followed for 7 months to roughly correspond to 6-months post-treatment. The secondary aim is to examine potential mediators of program effectiveness, including treatment engagement and changes in self-efficacy and perceived social support for quitting.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-24
* Past 30-day use of e-cigarettes containing nicotine
* Interest in quitting e-cigarette use in the next 30 days
* US residence

Exclusion Criteria:

* Failure to confirm mobile number after initial sign-up
Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local recurrence is still the major cause of failure together with distant metastasis. postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the overall survival. Adjuvant chemotherapy has also improved the survival in different studies. This study is performed to test the efficacy and toxicity of adding the two modalities together compared to each modality alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients not more than 70 years old.
* Radical cystectomy performed within 42 days with no microscopic or macroscopic residual after surgery (negative surgical safety margins)
* Having one or more of the risk factors ( P3b,P4a,G3 and /or positive LN)
* ECOG Performance Scale (0-2).
* Adequate liver functions.
* Adequate renal function serum (creatinine \< 1.5 mg).
* No evidence of distant metastasis or other malignancy.

Exclusion Criteria:

* patients who received radiotherapy or chemotherapy prior to radical cystectomy
Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment

The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine


Eligibility Criteria:
Inclusion Criteria:

* Patients who aged 18 to 65 years with a clinical history of migraine with or without aura (International Headache Society categories 1.1 or 1.2) for at least 1 year
* Subjects who have mean frequency of 2-8 migraine attacks per month.

Exclusion Criteria:

* Complex form of migraine, medication overuse headache, history of chronic tension-type headache, ophthalmoplegic, basilar and hemiplegic migraine
* Uncontrolled hypertension (diastolic blood pressure \>95 mm Hg or systolic blood pressure \>160 mm Hg)
* History or clinical evidence of cerebrovascular or cardiovascular disorder
* Renal impairment or dialysis dependence
* Serious illness (physical or psychiatric disorders)
* Drugs and alcohol abuse
* Pregnancy and breastfeeding
* Allergy or hypersensitivity to promethazine or triptans
* Concurrent use of ergotamine-containing drugs, monoamine oxidize inhibitors, antidepressant, lithium
Eosinophil β1 Integrin Activation as a Biomarker for Eosinophilic Esophagitis

The purpose of this study is to improve the overall management of patients with Eosinophil Esophagitis. Currently, the best way to monitor Eosinophil Esophagitis is repeating the endoscopy procedure. The investigators plan to identify a biomarker in the blood (a measurable substance) that tracks with disease activity and will reduce the need for follow-up endoscopies.

By definition, Eosinophil Esophagitis involves the presence of eosinophils in the esophageal mucosa. Although incompletely understood, the pathophysiology of Eosinophil Esophagitis is thought to include food allergen driven inflammation in the esophageal mucosa that triggers release of mediators for recruitment of eosinophils. The mediators, such as eotaxin, invoke eosinophil activation and trafficking into the esophageal tissue. The subsequent release of mediators from eosinophils and other cells, including mast cells and basophils, promotes inflammation and fibrosis resulting in Eosinophil Esophagitis symptoms. This protocol focuses on early eosinophil activation events in Eosinophil Esophagitis in the peripheral circulation, specifically activation of surface β1 integrin, as a biomarker for disease activity reflecting eosinophils destined for trafficking into the esophagus. Demonstrating a correlation between disease activity and a peripheral biomarker may ultimately facilitate a timelier, less invasive and less costly management strategy for Eosinophil Esophagitis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with no health concerns that might affect the outcome of the study,
* Age 18 years of age and older
* Esophageal dysfunction with a predominant symptom of solid food dysphagia and/or esophageal food impaction
* Esophageal eosinophilia (\>15 eosinophils/HPF) shown on biopsy
* In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.

Exclusion Criteria:

* Major health problems such as autoimmune disease, heart disease, type I and II diabetes, uncontrolled hypertension or lung diseases other than asthma. The listed health problems are definitive exclusion but decisions regarding major health problems not listed will be based upon the judgment of the investigator,
* Pregnant or lactating females or has a planned pregnancy during the course of the study.
Effects of Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients

The study will assess the total testosterone and sex hormone-binding globulin levels in men with type 2 diabetes before and after continuous subcutaneous insulin infusion and hypoglycemic drugs treatment.


Eligibility Criteria:
Inclusion Criteria:

* volunteer to participate and be able to sign informed consent prior to the trial.
* patients with type 2 diabetes, aged 18-60 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs.
* HbA1c \> 9%.
* subjects are able and willing to eat and exercise regularly.

Exclusion Criteria:

* patients with insulin allergy.
* impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.● drug abuse and alcohol dependence in the past 5 years.
* systemic hormone therapy was used in the last three months.
* patients with poor compliance and irregular diet and exercise.
* patients with infection and stress within 4 weeks.
* any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Progressive Relaxation Exercises on Anxiety Levels

The research will be conducted to determine the effect of progressive relaxation exercises on the anxiety level of patients who have had total knee replacement surgery.

The sample will not be selected from the universe and all patients who meet the inclusion criteria will constitute the sample. The minimum sample size of the study was determined by performing power analysis with the G-power 3.1.9.4 program. In the calculation made according to the two-way independent samples t-test, the effect size was taken as 0.80, with a margin of error of 0.05 and a power of 90%, the total sample number was calculated as 60 (Cohen, 1998). Considering the losses within the scope of the study, 66 patients who meet the inclusion criteria will be randomly divided into the experimental group (33 patients) and the control group (33). Finally, in order to minimize the risk of contamination, the first 33 patients who meet the inclusion criteria after being admitted to the clinic will constitute the control group, and the following 33 patients will constitute the experimental group.

Data will be collected using the 'Patient Identification Form' and the 'Beck Anxiety Scale'.

Progressive relaxation exercises were first applied by Dr. It is a technique of voluntary muscle contraction and relaxation developed by Edmund Jacobson in the 1920s. The main purpose of progressive relaxation exercises is for patients to understand the difference between muscle relaxation and tension and to be able to relax on their own. It combines the contraction and relaxation of large muscle groups such as the face, arms, legs, neck and back with deep breathing exercises. Before applying progressive relaxation exercises, the environment should be quiet, dimly lit, in a comfortable chair or armchair, sitting or lying down, and clothing should be loose and comfortable, and it is recommended to apply it one hour after eating. In the application of progressive relaxation exercises, it is first asked to breathe regularly. After our breathing rhythm is regulated, the hands, arm muscles, shoulder and neck muscles, chest, abdominal and hip muscles, legs, feet and facial muscles are contracted with a 5-7 second breathing exercise and relaxed during exhalation. This is repeated with 4-5 breathing exercises for each muscle and the exercise is ended when the eyelids are opened.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years old and above
* Speaking and understanding Turkish
* Having total knee replacement surgery
* Staying in the ward for approximately 96 hours after surgery
* Volunteering to participate in the study
* Not having a psychiatric diagnosis

Exclusion Criteria:

* Being under 18 years old
* Having speech and comprehension problems
* Not having total knee replacement surgery
* Early discharge after surgery
* Having complications after surgery
* Not volunteering to participate in the study
* Having a psychiatric diagnosis
Executive Function in Obese

This study was planned to examine the effect of executive function problems on physical performance and general well-being in obese individuals.


Eligibility Criteria:
Inclusion Criteria:

For the study group;

* Individuals volunteering for the study with BMI ≥30 kg/m2
* Individuals between the ages of 18-65 who volunteer to work
* Individuals who scored 21 points and above in the cognitive assessment

For the control group;

* Individuals volunteering for the study with BMI ≥30 kg/m2
* Individuals between the ages of 18 and 65 who are willing to work
* Scoring less than 21 points on the cognitive assessment

Exclusion Criteria:

* Being at a mental level that cannot understand and answer the questions posed
* Having a diagnosed neurological disease
* Having had cancer within the last 2 years
* Having major organ dysfunction
* Having uncontrolled type 2 diabetes
* Loss of vision, hearing
Immunomodulation Therapy for Urinary Tract Infections

Urinary tract infections (UTI) represent one of the most common morbidities in individuals with spinal cord injury (SCI) and reason for re-hospitalization. The consequences of recurrent UTI are a decrease in quality of life and considerable health costs. Immunomodulation therapy with UroVaxom is a very promising method for the prevention of UTI, however data in individuals with SCI are very limited. The primary objective of this pilot study is to evaluate the feasibility (recruitment rate, patient attrition, compliance, assessment procedures etc.) of a main trial. A secondary objective is to collect data for an informed sample size calculation. Furthermore, the clinical and biological changes after immunomodulation therapy will be investigated.

This is a randomized, placebo-controlled, mono-centric pilot study investigating the feasibility of a main trial regarding the effectiveness of immunomodulation with UroVaxom in the prevention of UTI and the effect on the immune system in individuals with acute SCI during primary rehabilitation. There will be two parallel groups of 12 participants each. Group allocation will be based on a block-randomization stratified according to sex. Study participants and outcome assessors will be blinded to the group allocation. The nursing staff will be unblinded and will administer the treatment and the placebo. Study participants will either receive Uro-Vaxom (one tablet / day) or an off-the-shelf placebo for 90 days. After termination of the treatment, the study participants will be followed for 12 months. Blood and urine samples will be taken before and 90 days, 6 months and 12 months after treatment start.


Eligibility Criteria:
Inclusion Criteria:

* acute SCI (within 8 weeks after SCI)
* onset of SCI within 72h
* age from 18 to 70 years
* informed consent as documented by signature

Exclusion Criteria:

* known hypersensitivity to investigational product,
* other immunomodulation therapy,
* immunosuppressant therapy,
* oncological condition or therapy,
* autoimmune diseases, nephropathy, bladder stones,
* women who are pregnant (pregnancy test) or breast feeding,
* participation in another study with an investigational drug within the 30 days preceding and during the present study
Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma

This trial is a multicentric study aiming to assess the evolution of the serum ifosfamide concentrations and its serum metabolites in patients treated for an Soft Tissue Sarcoma and co-exposed to Aprepitant.

The study will be conducted on a population of patients treated with Doxorubicin and Ifosfamide. The Aprepitant can be prescribed to patients from cycle 2, according to the current recommendations. Doxorubicin, Ifosfamide and Aprepitant will be administered in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.

Patients will be followed during the two first cycles of treatment. For the pharmacokinetic study, blood samples will be collected at different time points during the 2 treatment cycles.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Anatomopathologic diagnosis of soft tissue sarcoma (localized, local recidive or metastatic).
3. Patient receiving doxorubicin and ifosfamide chemotherapy (treatment decided during Multidisciplinary consultation meetings) (neoadjuvant, adjuvant or palliative treatment).
4. Screening laboratory values must meet the following criteria:

   1. Hemoglobin \> 9.0 g/dL, Neutrophils \> 1500/mm3, Platelets \> 100000/mm3
   2. Creatinine clearance (MDRD formula) \> 60ml/min.
   3. AST/ALT \< 2.5 x ULN (5 x ULN in patients with hepatic metastasis).
5. Evaluable disease (measurable per RECIST or not), if applicable.
6. Patient must provide written informed consent prior to any study specific procedures.
7. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Previous treatment with Ifosfamide.
2. Patient who has already started doxorubicin and ifosfamide treatment.
3. Any medical condition that can increase the patient's risk

   1. Active infection
   2. Active hepatitis or cirrhosis
   3. Recipients of organ transplants or immunocompromised patients, including Human Immunodeficiency Virus (HIV) infection
4. Pregnant or breastfeeding women
5. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
6. Patient protected by law
A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.

This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms \[mcg\] subcutaneously \[SC\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.


Eligibility Criteria:
Inclusion Criteria:

* Chronic renal anemia
* Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks

Exclusion Criteria:

* Transfusion of red blood cells during previous 8 weeks
* Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
* Acute or chronic bleeding requiring therapy within previous 8 weeks
Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting As Indolent Lymphoma

Most relapses of diffuse large B-cell lymphoma (DLBCL) occur as high-grade lymphoma within the first two years after diagnosis. Relapses as indolent lymphoma are rare events, and the true incidence of this phenomenon is unknown, since literature data are scarce/ and usually restricted to case reports. Analogously, reported treatment strategies are rather heterogeneous, since no standard of care is established and advanced age together with previous anthracycline exposure may narrow the therapeutic choice.

The goal of this observational study is to assess epidemiological, clinical characteristics and survival of diffuse large b-cell lymphoma (DLBCL) relapsing as indolent lymphoma.

More precisely, the study aims at identifying diagnostic and imaging features associated with relapse as indolent lymphoma and at evaluating disease response to selected therapies.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at the time of diagnosis.
* Previous diagnosis of diffuse large B-cell lymphoma with/without a discordant component of indolent B-cell lymphoma, or previous diagnosis of diffuse large B-cell lymphoma transformed from indolent B-cell lymphoma.
* First-line treatment for diffuse large B-cell lymphoma.
* Histologically documented relapse of indolent B-cell lymphoma, diagnosed between 2010 and 2020.
* Availability of the histological report of the relapse.
* Availability of clinical and laboratory data related to both the initial diagnosis and relapse.
* Availability of follow-up data.
* Consent to participate in the study and signing of the specific informed consent form (for living and/or contactable patients).

Exclusion Criteria:

- None
Postspinal Headache and Near Infrared Spectroscopy (NIRS)

Evaluation of the relationship between postspinal headache and near infrared spectroscopy in cesarean section patients

Patients with cesarean section under spinal anesthesia were included in the study. Before the study, patients were moniterized with NIRS device in the preoperative waiting room.NIRS moniterization was continued intraoperatively at 1st, 4th, 7th, 10th, 15th, 30th minutes and 24th postoperative period.

Patients were divided into two groups as those with postspinal headache (Group A) and those with postspinal headache (Group B). In this study, NIRS values between two groups were compared.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean section

Exclusion Criteria:

* Not willing to participate in the study
* Use of anti-psychotic or anti-depressant drugs
* Patients with headaches
Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma

This is an open-label, randomized, controlled trial. At the end of a 28-day screening period, all eligible subjects will be randomly assigned into treatment Arm A or B in a 1:1 ratio. Subjects in Arm A will receive a maximum of 6 cycles of chemotherapy (cisplatin plus paclitaxel) and cetuximab weekly in the absence of progressive disease (PD), as assessed by the Investigator, and unacceptable toxicity. After 6 cycles of treatment, subjects who derive clinical benefit will continue treatment with cetuximab as monotherapy until either PD or unacceptable toxicity. Subjects in Arm B will receive the same chemotherapy regimen as Arm A alone for a maximum of 6 cycles in the absence of PD and unacceptable toxicity.


Eligibility Criteria:
* Inclusion Criteria:

  * Signed written informed consent.
  * Older than 18 years of age.
  * Histologically proven squamous cell carcinoma of the esophagus.
  * Metastatic ESCC, not suitable for local-regional treatment.
  * Presence of at least 1 measurable lesion according to RECIST version 1.1.
  * ECOG performance status of 0 or 1.
  * Adequate bone marrow, haptic, renal, metabolic function.
* Exclusion Criteria:

  * Prior chemotherapy in the metastasis setting.
  * Prior chemotherapy within 6 months before entering this study.
  * Previous exposure to EGFR-targeted therapy.
  * Known central nervous system metastasis and/or leptomeningeal disease.
  * Subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the trial at the discretion of investigator.