cyrilzakka/clinical-trials huggingface dataset:
Open-Label Study of ARD-0403 in Testosterone Deficient Men

Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient well-being. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.


Eligibility Criteria:
Inclusion Criteria:

* Testosterone deficiency
* Completed study ARD-0403-004

Exclusion Criteria:

* Previous treatment with testosterone replacement therapy within 4 weeks
* Moderate-severe benign prostatic hypertrophy or prostatic cancer
* Haematocrit \>50%
Online Proton Adaptive Radiotherapy

This is a pilot study evaluating the feasibility of daily online adaptive planning for patients undergoing proton radiation therapy.

Patients undergoing proton radiation therapy normally undergo extensive pre-planning for their treatment. However, accounting for uncertainties in treatment delivery remains a challenge for a variety of reasons, such as differences in patient anatomy from pre-planning to the day of treatment. Online adaptive planning is a process consisting of generating the original pre-plan on the patient on a treatment day, assessing the pre-plan's coverage and safety, and if changes are needed, the plan is changed in order to optimize the treatment while the patient is still on the treatment table. This study is assessing the feasibility and safety of this approach in order to gather data for a larger trial.


Eligibility Criteria:
Inclusion Criteria:

* Oligometastatic or primary malignancy planned for proton SBRT. Disease site should be biopsy-proven primary disease of solid tumor histology with the exception of Hepatocellular carcinoma (HCC). HCC does not need to be biopsy proven if imaging and clinical findings are consistent with the diagnosis.
* Must be deemed medically fit for proton SBRT by the treating physician.
* Prior radiation therapy is allowed.
* At least 18 years of age.
* Karnofsky ≥ 70%.
* Because radiation therapy is known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, or a male suspect he has fathered a child, s/he must inform the treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Histology of small cell carcinoma. Mixed histologies with a predominantly small cell component are also exclusionary.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Medical contraindication to proton therapy or any other condition that in the opinion of the treating radiation oncologist, renders the patient unfit for SBRT
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of study entry.
A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine

To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT).

Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC, was discontinued.)

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* G-CSF and erythropoietin.
* Prophylaxis or chronic suppression/maintenance therapy with dapsone, aerosolized pentamidine, isoniazid, rifampin, fluoroquinolones, pyrazinamide, ethambutol, fluconazole, itraconazole, acyclovir, clotrimazole, nystatin, trimethoprim/sulfamethoxazole, pyrimethamine, folic acid, sulfadiazine, clindamycin, and fansidar.

Concurrent Treatment:

Allowed:

* Limited localized radiation therapy to the skin.

Patients must have:

* Documented HIV infection.
* CD4 count 50 - 300 cells/mm3.
* Received prior AZT that has been discontinued at least 28 days prior to study entry.
* No active opportunistic infection requiring immediate treatment.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Signs or symptoms of peripheral neuropathy.
* Malabsorption or inadequate oral intake (defined as unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort.
* Malignancy, visceral Kaposi's sarcoma, or lymphoma requiring systemic chemotherapy and/or radiotherapy within the next 48 weeks.
* Any grade 3 or worse laboratory or clinical abnormality.
* Inability to comply with protocol requirements.

Concurrent Medication:

Excluded:

* Other antiretroviral drugs.
* Experimental drugs.
* Nephrotoxic or hepatotoxic drugs.
* Drugs likely to cause peripheral neuropathy.
* Antineoplastic agents.
* Biologic response modifiers.

Concurrent Treatment:

Excluded:

* Radiation therapy other than limited localized therapy to skin.

Patients with the following prior conditions are excluded:

* History of non-Hodgkin's lymphoma.
* Unexplained fever \>= 38.5 C (101.5 F) persisting for 14 days or longer within the 28 days prior to study entry.
* Unexplained, chronic diarrhea (defined as 3 or more loose stools daily) persisting for 14 days or longer within the 28 days prior to study entry.
* History of grade 2 or worse peripheral neuropathy.

Prior Medication:

Excluded:

* Prior HIV proteinase inhibitor.
* Prior antiretroviral therapy other than AZT.
* Acute therapy for opportunistic infection within 14 days prior to study entry.

Prior Treatment:

Excluded:

* More than 3 units of blood in any 21-day period within 3 months prior to study entry.

Required:

* Prior AZT.
Clinial Application of Park et al.(The Knee 27 (2020) 1577-1584)'s Study

The goal of this study was to perform pulsed radiofrequency ablation with a modified target suggested in the cadaver study by Park et al. (The Knee 27 (2020) 1577-1584) on knee osteoarthritis patients, and to evaluate the effect of reducing the frequency of intravascular injection and reducing pain.


Eligibility Criteria:
Inclusion Criteria:

1. chronic knee pain that does not respond to conservative treatment (physiotherapy, oral analgesic, steroid intra-articular injection, Hyruan injection) for more than 6 months
2. A score of 6 or higher (out of 10) on the target knee's numerical rating scale
3. Knee osteoarthritis 1-4 confirmed in knee X ray within 6 months of study enrollment

Exclusion Criteria:

1. Systemic inflammatory diseases such as rheumatic diseases
2. uncontrolled diabetes
3. malignant tumor
4. If the target knee has a previous surgical history (arthroscopy, arthroscopy, autologous or allograft osteochondral transplantation and autologous cartilage cell transplantation, osteotomy, arthritis surgery)
5. Patients with lidocaine and contrast agent allergy
6. history of nerve block in the target knee within 2 weeks
7. Body mass index over 40 kg/m2
8. bleeding disorder
9. Pregnant/lactating women
10. Inability to understand informed consent and respond to research questionnaires due to cognitive impairment
11. Unable to read consent form (e.g. illiterate, foreigner, etc.)
Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest)

To assess the efficacy of recombinant human C1-esterase inhibitor in the management of HAE prodrome for preventing the progression from prodrome to an acute angioedema attacks. Subjects will either receive Ruconest after the first 2 prodromes or during the last 2 prodromes. 5 clinic visits will occur within 24 hours of a prodrome. Subjects will complete prodrome severity and angioedema attack diaries

After screening, subjects will be followed in the study for four consecutive prodromes. For prodromes designed to be treated with Ruconest, the drug will be administered within 12 hours of prodromal onset and prior to the onset of objective selling. Ruconset will be self-administered at home or by a healthcare professional at the recommended dose of 50 IU/kg body weight with maximum dose of 4200 IU as a slow IV injection over 5 minutes Subjects will be randomized into two arms after enrollment. Subjects in Arm A receives Ruconest after 1st and 2nd prodrome and no Ruconest after 3rd and 4th prodromes. Subjects in Arm B receive no Ruconest after 1st and 2nd prodrome and Ruconest after 3rd and 4th prodromes.

Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of HAE Type 1 and 2,
* One or more HAE attacks per month,
* History of 4 prodromes that proceed to angioedema attacks

Exclusion Criteria:

* History of thrombosis or arterial/venous thromboembolic attacks
* History of atherosclerosis, morbid obesity, immobility
* History of allergy to rabbits or products from rabbits
* History of life-threatening immediate allergic reactions to C1 esterase inhibitor preparations
Effects of Inhibition Compression Versus Scapular Mobilization Technique on Shoulder in Patients With Mastectomy

A mastectomy is a medical surgery in which the breast is removed whole or in part. Breast cancer is the second most prevalent cancer diagnosed in women. Rotator cuff dysfunction-related shoulder pain is a common symptom associated with mastectomy, reconstruction, and therapy for breast cancer.) Patients who get treatment for breast cancer report reduced strength (prevalence 17-33%), loss of upper limb range of motion (prevalence 2-51%), and reduced ability to carry out daily life tasks.

The study aims to observe the effectiveness of inhibition compression therapy versus scapular mobilization on shoulder in patients with mastectomy. By investigating the effectiveness of inhibition compression therapy versus scapular mobilization, this study can contribute to improved pain management, enhanced quality of life, and reduced healthcare utilization for breast cancer survivors. It will be randomized control trial (RCT). The study will be conduct in Gujranwala institute of nuclear medicine. It will be non-probability convenience sampling technique. Duration of the study will be 6 months after the approval of synopsis

Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 75 years (42)
* unilateral breast cancer followed by chemotherapy or radiations. (27)
* modified radical mastectomy surgery (27)
* limited ROM of shoulder
* Female

Exclusion Criteria:

* Patients with recurrent breast cancer (42)
* History of ischemic heart disease
* History of high blood pressure
* History of other surgery
* Any neurological issue
Baduanjin Exercises on Shoulder Dysfunction Post Thyroidectomy

This study will be carried out at the outpatient clinic of the faculty of physical therapy, Cairo university, El Galaa general hosbital after referral from endocrine surgeon. Participants will perform these exercises in a room supervisor physiotherapist.

All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

This study will investigate the effects of Baduanjin exercises on shoulder dysfunction post thyroidectomy. To assign patients to different treatment groups, a table of random numbers generated by a computer was used. Patients were allocated randomly into two groups using this method. This study will be carried out at the outpatient clinic of the faculty of physical therapy, Cairo University, El Galaa general hospital and National Cancer Institute in Cairo to be treated in the outpatient clinic after referral from endocrine surgeon. Participants will perform these exercises in a room supervisor physiotherapist.

All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

Eligibility Criteria:
Inclusion Criteria:

* They have the development of the shoulder dysfunction (Range of motion limitation and shoulder pain) (limitation of 20 ≥ ROM in shoulder flexion, abduction, external or internal rotation) after thyroidectomy.
* Patients who were 6 months to 1 year post unilateral neck dissection
* Aged 30- 50 years (at the time of surgery)

Exclusion Criteria:

* they had severe cardiac disease, uncontrolled hypertension and upper extremity problems started Before treatment of thyroid cancer surgery.
* Patients with neurological disease, rheumatologically disease, communication problems, recurrent infections, and history of head or neck malignancy, history of \> 1 neck dissection, history of bilateral neck dissection,
* open wounds or incision presence in the region and patients proceeding with chemotherapy (CT) or radiotherapy (RT) were barred
Day-care Unit for Patients With Refractory Heart Failure

The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is an observational study on selected patients with advanced refractory heart failure. The purpose of the study was to examine the comprehensive management of HF in the day-care unit in terms of the safety and its impact on the rehospitalization and mortality rates in patients with advanced refractory HF.

The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is a single-center observational study conducted in the 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Silesian Centre for Heart Disease in Zabrze, Poland.

The main objective of the DayCare-HF is to verify the hypothesis that comprehensive and multidisciplinary day-care management of patients with refractory heart failure (HF) is safe and beneficial in terms of hospital readmission due to HF and al cause mortality.

The study population is formed by selected patients with heart failure, hospitalized in cardiology wards and intensive cardiac care unit of Silesian Centre for Heart Disease, who fulfilled eligibility criteria.

During the scheduled visits comprehensive medical service is provided, including education, diagnostic tools (electrocardiography, transthoracic echocardiography, implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy device (CRT) interrogation and additional treatment (intravenous loop diuretic, dobutamine, vasodilators administration).

The patients are under constant follow-up for major adverse events, heart transplantation, hospital readmissions due to HF and all cause mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Optimally decongested heart failure in New York Heart Association (NYHA) class II-IV, treated for at least 6 months
2. Performance of all possible reparative procedures if indications were present (cardiac revascularization, correction of valvular heart disease, cardiac ablation, cardiac resynchronization therapy)
3. Implantation of cardioverter-defibrillator (ICD) if applicable
4. At least two unplanned hospitalizations for heart failure during preceding 6 months

Exclusion Criteria:

1. Inability to travel to the unit
2. Non-compliance with the medical recommendations
Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study

Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different.

Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.

Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical.

Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 50

Exclusion Criteria:

* Psychiatric disease
* Inflammatory bowel disease
* inability to understand Swedish
Impact of Mirabegron on Erectile Function in BPH Patients

Evaluation of impact of Mirabegron on erectile function for patients treated for BPH

50 patients (Group A) will receive Mirabegron \& alpha blocker 50 patients (Group B) will receive alpha blocker only Evaluation using IIEF 5 scoring system

Eligibility Criteria:
Inclusion Criteria:

* All males above age 50 with LUTS due to BPH not candidate for prostatectomy

Exclusion Criteria:

* males below age 50
* neurologic abnormality
* Any indication for prostatectomy
* abnormal bladder contractility i.e diabetics
19/5000 (SYNAPSOT21) Predictive Factors of Sleep Apnea Syndrome in Down Syndrome

The obstructive sleep apnea syndrome (OSAS) is frequently reported in subjects with trisomy 21. The consequences of this syndrome are expressed in various disorders such as cognitive and cardiovascular alterations. It is also reported a premature exhaustion with the achievement of various professional or recreational activities, as well as an increase in the frequency of daytime sleepiness. In trisomy 21, there are factors that are systematically associated with obstructive apnea. The identification of these factors would make it possible to diagnose OSAS earlier, under-diagnosed in the population with trisomy 21 even though these OSAS are associated with increased cardiovascular risks.

The aim of this study is to identify the predictive factors associated with sleep apnea in the trisomy population in order to propose early detection.

OSAS treatment in a young adult with Down syndrome could reduce physical fatigue apparition during various activities, reduce daytime sleepiness, and have a positive impact on physical fitness, and therefore more broadly on health.

The predictive factors for OSA that will be studied are: physical activity level, dentofacial disharmonies, blood parameters, motor disabilities, heart rate variability parameters measured during sleep and during autonomic nervous stimulation by orthostatic test.

All these factors will be linked to the data obtained by:

1. polysomnography
2. by the joint use of seismocardiography

OSAS lead to many associated disorders, which identified early can be better supported to limit the deleterious effects of this OSAS:

(i) a sudden and repeated activation of the sympathetic nervous system triggered by sleep fragmentation (ii) intermittent hypoxia associated with OSAS may increase insulin resistance through the involvement of an inflammatory state and oxidative stress.

(iii) a significant level of diurnal fatigue limiting activities, thus promoting a sedentary lifestyle and increasing cardiovascular risk factors.

Several secondary objectives will therefore be studied:

1. Can OSAS be predicted by the existence of autonomic dysfunction?
2. Can OSAS be predicted by specific biological disturbances?
3. Can OSAS be predicted by the presence of a specific cranial structure?
4. Can OSAS be predicted by an insufficient level of physical activity?

Finally does the use seismocardiography make it possible to identify quickly and early these risk factors linked to OSAS?

Eligibility Criteria:
Inclusion Criteria:

Subjects with Down syndrome, able to practice physical activity all participants have received information all have signed the consent form

Exclusion Criteria:

* pregnant women
* Pharmacological treatment altering autonomic nervous system (ANS)
* Contra-indication to physical exercise, such as atlanto-axial instability
Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis

This is a prospective, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.

Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of 2181 gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with endoscopically removed malignant polyps.
* Male or female ≥ 18 years of age on the day of signing informed consent.
* Patients who received surgical resection following removal of malignant polyps by colonoscopy.
* Patients must have a performance status of ≤1 on the ECOG Performance Scale.
* Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study

Exclusion Criteria:

* Patients received adjuvant treatment prior to the surgical resection.
* Patients received blood transfusion two weeks before or during the surgical resection.
* Patients with unresected advanced colorectal adenoma.
* Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
* Patients who are pregnant.
* Patients who are alcoholic or drug abusers.
* Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.