cyrilzakka/clinical-trials huggingface dataset:
Prospective Hyperthermia Database in Cancer Patients (HT Register)

This monocentric study registry records all cancer patients at the Charité which are treated with hyperthermia to examine the therapeutic use of hyperthermia in cancer patients in the general application and to obtain an accurate risk-benefit balance

After confinement in this database are the patients prospectively in order to complications, disease status and survival status tracked.

Furthermore there is the possibility in the course of this study to an optional take part in translational accompanying research with the aim of prognostic factors for response to hyperthermia treatment.

A total of 1000 patients with various diseases with the indication for hyperthermia in addition to standard oncological therapy (radiation therapy, chemotherapy, radiochemotherapy) will be included in this registry protocol.

Eligibility Criteria:
Inclusion Criteria:

* Contrazeption with female patients at the capable of bearing children age
* Written agreement is present (DvH, ICH-GCP)
* Patients, who participate at the same time in a interventional study, can nevertheless in this register study participate if this none Exclusion criterion for the interventional study represents.
* With children must the treatment with one of the GPOH agreed Pattern take place

Exclusion Criteria:

* Exclusion criteria for the hyperthermia (such as hip prosthesis in the therapeutic area, metal implants/marker, patients with cardiac pacemakers)
* mental disease, what the proper study participation does not allow.
Feasibility Study of Breast MRI in Decubitus Position

Breast MRI is performed in prone position which causes a number of questions. Indeed, the correlation with mammography and echography and the identification of preoperative lesions can be complex as echography and surgery are carried in supine position while mammography is performed in standing position.

Moreover, the prone position is often considered as uncomfortable by the patients. However, there is few publications in the literature on breast MRI in decubitus position.


Eligibility Criteria:
Inclusion Criteria:

* Patient to benefit a MRI in the assessment for a breast carcinoma or a suspicious of breast carcinoma
* Assessment on 3.0 Tesla in Magnetic Resonance Imaging
* Age \>18 years old
* ECOG performance status ≤ 3
* Ability to provide written informed consent form

Exclusion Criteria:

* Age \< 18 years old
* Claustrophobia
* Contraindication to the injection of contrast medium Gadoline
* Contraindication to MRI
* Persons deprived of liberty or under supervision
Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients

Food intake has a great influence on blood glucose of patients with diabetes. This study was designed to determine the glycemic index (GI) of a particular pomelo named Majia pomelo and its effects on postprandial glucose (PPG) excursions in both healthy subjects and patients with type 2 diabetes (T2DM).

The purpose of this study was to evaluate the GI and effects on glucose excursion of Majia pomelo in both healthy and diabetic subjects. The results may help diabetic subjects and their health care providers in developing a diet that is both medically and culturally appropriate.

Eligibility Criteria:
Inclusion Criteria:

* In the diabetic and diabetic 2 groups, it required that their diabetes was controlled (HbA1c ≤ 8%) on diet with or without metformin.

Exclusion Criteria:

* Morbid obesity (BMI \> 40 kg/m2)
* Pre diabetes
* Pregnancy
* Presence of gastroenterological disorders
* Alimentary tract surgery
* A history of gastroenteritis in the prior six months
* Any alcohol intake
* Smoking
* Taking any medications (except metformin)
* Poorly controlled diabetes (HbA1c \> 8%)
* Presence of chronic diseases (such as bronchial asthma or rheumatoid arthritis) or acute illness (such as upper respiratory tract or urinary tract infection)
A Study in Male and Female Adult Patients With Atopic Dermatitis Treated With Dupilumab in Taiwan

Primary objective:

To characterize the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment for adult AD patients, who are eligible for dupilumab reimbursement in Taiwan (e.g., used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching).

Secondary objectives:

* To characterize the adult AD patients, who are eligible for dupilumab reimbursement in Taiwan, with respect to their a) medical history, b) socio-demographic, c) disease characteristics, d) comorbid with type 2 diseases \[e.g., Asthma, Chronic rhinosinusitis with nasal polyp (CRSwNP)\], and e) prior and concomitant treatments of atopic dermatitis
* To assess the effectiveness and safety of dupilumab in adult atopic dermatitis patients, who are eligible for dupilumab reimbursement in Taiwan
* To assess comorbid atopic conditions and effects of dupilumab treatment for comorbid atopic conditions in adult patients, who are eligible for dupilumab reimbursement in Taiwan
* To evaluate the correlation of patient reported outcome \[Atopic Dermatitis Control Tool (ADCT)\] and physician assessment \[Eczema Area and Severity Index (EASI)\] from the recruited subjects

1 year

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years or older at the baseline visit
* Initiating treatment with dupilumab for AD, who are eligible for dupilumab reimbursement according to the country-specific prescribing information

Note: Patients, who are diagnosed with AD more than 6 months, Eczema Area and Severity Index (EASI) more than or equals to 20. body surface area (of AD involvement) (BSA) more than or equals to 30% and IGA=3-4, may be eligible if they have already initiated treatment with:

1. Phototherapy (psoralen + ultraviolet light A (PUVA) or narrow-band ultraviolet B (nb-UVB) twice a week) more than 3 months, and,
2. Two different immunosuppressants (methotrexate, azathioprine, or cyclosporine) more than 3 months respectively before their enrollment in the registry.

   * Provided signed informed consent

Exclusion Criteria:

* Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments
* Patients currently participating in any interventional clinical trial which modifies patient care
* Patients who have a contraindication to dupilumab according to the country-specific prescribing information

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Brief Pain Reprocessing Therapy in Veterans

This research is studying whether a Zoom-based behavioral intervention may have an impact as a treatment for Veterans with Chronic Low Back Pain (CLBP).

The study will examine:

* The acceptability of the Brief Pain Reprocessing Therapy (BPRT) intervention
* The feasibility of the BPRT intervention
* The safety of the BPRT intervention

This study will take place remotely and there will be no on-site visits.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain that has lasted greater than 6 months, with pain on at least half of these days
* Must provide verification of being an Armed Service Veteran.
* Able to read, write and speak English
* Internet access and audio-conferencing capability (e.g., Zoom meetings by phone or computer) in the home

Exclusion Criteria:

* Self-reported evidence of a separate medical condition (e.g., rheumatoid arthritis), acute injury in the past 12 months (e.g., self-reported spinal fracture), self-reported loss of bowel or bladder control in the past year (which may indicate presence of cauda equina syndrome), or evidence of presence of a metastasizing cancer requiring treatment
* Pending surgical procedures or interventional therapies (e.g., spinal injections) within the next 12 months
* Confirmed/suspected pregnancy
* Evidence of other conditions that may preclude participants from understanding or being able to participate in study procedure (e.g., schizoaffective disorder, suspected or diagnosed dementia)
* Currently receiving cognitive-behavioral therapy or other psychological therapies for pain
* Open litigation in the past 1 year, as assessed in preliminary study screening.
* Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.
Olodaterol Bridging Study in Asthma

The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).


Eligibility Criteria:
Inclusion criteria:

1. Informed Consent Form consistent guidelines and local legislation prior
2. Male or female patients aged at least 18 to 75 years.
3. Diagnosis of asthma according to the 2009 Global Initiative for Asthma (GINA) Guidelines.
4. Maintenance treatment with a low or medium dose of inhaled corticosteroids (ICS) with or without Long-acting beta-adrenergic (LABA), stable dose of inhaled corticosteroids (alone or in a fixed combination with a LABA) for at least for 6 weeks prior to screening.
5. Asthma control questionaire (ACQ)-6 mean score of \< 1.5.
6. a. Pre-bronchodilator clinic measured FEV1 =50% and =90% of predicted normal b. FEV1 reversibility: Improvement in FEV1 =12% above baseline and an absolute change of at least 200 ml within 15-30 minutes after administration of 400 µg salbutamol.
7. Never-smokers or ex-smokers with a smoking history of less than 10 pack-years and smoking cessation at least one year prior to screening.
8. Be able to use the inhalers correctly in the opinion of the investigator.
9. Be able to perform all trial related procedures.

Exclusion criteria:

1. Significant disease other than asthma.
2. Recent history (i.e. six months or less) of myocardial infarction.
3. Hospitalisation for cardiac failure during the past year.
4. Unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
5. Lung diseases other than asthma (e.g. Chronic obstructive pulmonary disease).
6. Active tuberculosis.
7. Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
8. Thoracotomy with pulmonary resection.
9. Alcohol or drug abuse within the past two years.
10. Pulmonary rehabilitation program
11. Hypersensitivity to LABA drugs, ciclesonide, salmeterol or any other components of the study medication delivery systems.
12. Pregnant or nursing woman.
13. Women of childbearing potential not using a highly effective method of birth control.
Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy

This pilot clinical trial studies how well Tai Chi Easy works in treating cancer survivors with peripheral sensory neuropathy. Tai Chi Easy is a simple and repetitive form of exercise that consists of movements with meditation and may improve peripheral neuropathy symptoms among cancer survivors.

PRIMARY OBJECTIVES:

I. Examine effects of Tai Chi Easy (TCEasy) exercise intervention on peripheral sensory neuropathy of cancer survivors who have chemotherapy compared with an educational control (EC) intervention.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (TAI CHI EASY): Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks. Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks.

GROUP II (EDUCATIONAL CONTROL): Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.

After completion of study, patients are followed up at 2 months.

Eligibility Criteria:
Inclusion Criteria:

* 1 month - 5 years following completion of cytotoxic chemotherapy treatment for any cancer, and are experiencing neuropathy
* Self-report of \>= 4 on the Peripheral Neuropathy Question

Exclusion Criteria:

* Recurrence of cancer or other active cancer
* Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
* Uncontrolled diabetes, untreated hypothyroidism
Project WHADE: A Partner-Based Physical Activity Program for Women

This study is designed to test the feasibility and acceptability of a new method for supporting physical activity among women ages 40-65 who have risk factors for cardiovascular disease. Each participant receives a trained physical activity coach and a physical activity partner; the partner is another woman in the program. Partners communicate with each other between weekly coaching sessions to provide support for physical activity behavior change.

The purpose of this study is to test the feasibility and acceptability of a new method for supporting physical activity in women ages 40-65 who have risk markers for cardiovascular disease. The primary goal is to understand perceptions of support and communication patterns between partner dyads of women in midlife (ages 40-65). The creation of these partner dyads is a promising method for promoting social support and physical activity for this population. Understanding how partners communicate with one another throughout this intervention study will give insight into how women in this population maximize benefits from partnership through communication and shared experiences (e.g., age, gender, cardiovascular disease risk, interest in being more physically active).

Eligibility Criteria:
Inclusion Criteria:

* One or more of the following health conditions: smoking (current or quit in the last 3 months), or a physician diagnosis of prediabetes or type 2 diabetes, prehypertension or hypertension (high blood pressure), hypercholesterolemia or hyperlipidemia(high cholesterol), or metabolic syndrome
* Engaging in less in less than 6500 steps per day or less than 90 minutes of structured exercise per week
* Access to personal mobile device
* Fluent in English

Exclusion Criteria:

* Pregnant or intend to become pregnant in the next 9 weeks,
* Medical or psychiatric situation that hinders the ability to perform physical activity
* None one of the following cardiovascular risk behaviors or conditions: smoking, diagnosed prediabetes/type 2 diabetes, prehypertension/hypertension, high cholesterol, or metabolic syndrome
* Not fluent in English,
* No access to a personal mobile device
Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma

The objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.

Gemcitabine shows promising activity in patients with relapsed lymphoma either administered as single agent or in combination with other cytotoxic agents. No trial to date evaluated its role in patients with primary Hodgkin's lymphoma. We therefore developed a three-weekly regimen based on the standard ABVD regimen.

Eligibility Criteria:
Inclusion Criteria:

* Hodgkin's lymphoma (histologically proven)
* Clinical stage IIB (with risk factors bulky mediastinal mass and/or extranodal involvement), III, or IV
* No prior antitumor therapy
* Age 60 to 75 years
* WHO performance status 0-2
* Normal pulmonary function
* Written informed consent

Exclusion Criteria:

* The following histologies are excluded: lymphocyte predominant HD
* Leukocytes \< 2,500/microL
* Platelets \< 100,000/microL
Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.

OBJECTIVES:

* Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma.
* Assess the toxicity of this therapy in these patients.

OUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma).

Patients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: This study will accrue a maximum of 68 patients within 18-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed recurrent primary low grade glioma including:

  * Fibrillary astrocytoma
  * Oligodendroglioma
  * Mixed glioma
* Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* Hematocrit greater than 29%
* Absolute neutrophil count greater than 1500/mm\^3
* Platelet count greater than 125,000/mm\^3

Hepatic:

* SGOT less than 1.5 times upper limit of normal (ULN)
* Bilirubin less than 1.5 times ULN

Renal:

* Creatinine less than 1.5 mg/dL
* BUN less than 25 mg/dL

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy unless disease progression

Endocrine therapy:

* Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study)
* No concurrent immunosuppressive agents

Radiotherapy:

* At least 4 weeks since prior radiotherapy unless disease progression

Surgery:

* Not specified

Other:

* No other concurrent medication that may interfere with study
First-in-Human Single and Multiple Dose of GLPG1205

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo.

Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer

The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can improve PSA progression times for patients with Metastatic Prostate Cancer.

Use of vaccine to improve Prostate Specific Antigen (PSA) levels.

Eligibility Criteria:
Inclusion Criteria:

* Male 18 years and older
* Histologically confirmed prostate adenocarcinoma
* Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy)
* Androgen deprivation therapy using Luteinizing-hormone-releasing hormone ( LHRH) analogues commenced at least one month and at most three months prior randomization or orchiectomy performed at least one month and at most three months prior randomization
* Serum testosterone level at screening (≤ 1.7 nmol/l, resp. ≤ 50 ng/dL)
* Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

* Confirmed brain and/or leptomeningeal metastases
* Prior or ongoing chemotherapy for prostate cancer
* Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
* Other uncontrolled intercurrent illness
* Treatment with immunotherapy against prostate cancer
* Clinically significant cardiovascular disease
* Active autoimmune disease requiring treatment
Pulsed Radiofrequency of S2-4 Versus Ganglion Impar Neurolysis for Severe Perianal and Perineal Pain in Cancer Patients

Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures.

Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures. Ganglion impar block has been traditionally used for treatment of such perineal pain. Radiofrequency of sacral dorsal root ganglia can be used as an alternative for pain control.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-75 years
* ASA II-III with perianal and perineal pain related to cancer

Exclusion Criteria:

* patient refusal
* coagulation defects
* abnormal kidney or liver functions
* local infection at site of injection
Evaluation of Obex® in Overweight and Obesity

* Obesity is an important and growing worldwide
* Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer
* Diverse adverse events have been reported with the use of antiobesity drugs.
* Several articles describe the beneficial effect of several specific components of the Obex® supplement on weight loss, in the reduction of waist circumference, suppression of appetite, decrease fasting glucose levels, improvement of insulin sensitivity and β cells function.
* Therefore, the administration of Obex in overweight and obese patients could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.


Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfill the diagnosis criteria of overweight or obesity (BMI ≥ 25.0 and less than 40).
* Age between 20 and 65 years old.
* Values of fasting glucose \< 7.0 mmol / L and at two hours \< 11.1 mmol / L during Glucose Tolerance Test (OGTT).
* Written informed consent of participation in the study.

Exclusion Criteria:

* Thyroid dysfunction (hypo or hyperthyroidism).
* Type 1 or type 2 diabetes.
* Prediabetes treated with oral agents.
* Alterations of lipids treated with drugs.
* Medicine consumption of or dietary supplements that influence the reduction of body weight.
* Consumption of steroids or prolonged use of them (last 3 months).
* Treatment with immunosuppressive drugs.
* Chronic diseases (of the hepatic, renal and cardiovascular systems, pancreatitis or some type of malignancy condition) or acute at the time of inclusion.
* Insulin resistance due to diseases such as acromegaly, endogenous hypercortisolism, polycystic ovarian syndrome or hyperprolactinemia.
* History of symptomatic hypoglycaemia.
* History of chronic debilitating diseases, anemia and collagen diseases.
* History or existence psychological illness with eating disorders or toxicity.
* History of alcoholism or drug dependence.
* Inability to comply with the instructions of the investigation.
* Severe infections at the time of inclusion.
* Women of childbearing age who use hormonal contraceptives (oral or injectable).
* Pregnant or breastfeeding.
* Known sensitivity to any of the components of the formulation
* Gynoid fat distribution.