cyrilzakka/clinical-trials huggingface dataset:
Elevate! : An Elderly Breast Cancer Cohort Study

This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer.

This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer, a group of participants who often have low risk cancers, but who may do worse than younger participants with the same kind of cancers. Researchers want to better understand the experiences, barriers, and changes in physical function older participants with breast cancer have.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 or older at the time of diagnosis (as indicated by the date of breast biopsy)
* No more than 67 patients (1/3) will be aged 70-74, with the remaining patients on study ages 75 or older
* Any gender is eligible
* Invasive, non-metastatic breast cancer at diagnosis
* Those with prior diagnoses of pre-invasive (DCIS) or invasive breast cancer are eligible as long as their current diagnosis is felt by the treating provider to represent a NEW non-metastatic primary invasive breast cancer (e.g. someone with a nodal recurrence from prior disease are not eligible but those with a new contralateral breast cancer 3 years after a first breast cancer would be eligible)
* Any breast cancer subtype is allowed
* Breast cancer-diagnosing biopsy within 90 days of enrollment
* Receiving or will receive medical oncology care (+/- surgical and radiation oncology treatments) at the participating center: DFCI/satellites and affiliate sites
* Patients must be able to understand, speak, and read English or assign a designated caregiver/proxy for the duration of the study who understands, speaks, and reads English and who is willing to assist with filling out the survey components which do not have a validated, translated version. This is because the surveys are not readily available in multiple languages as a whole, although some components (such as the Geriatric Assessment and PROs are readily available in multiple languages).
* If a patient scores 11 or higher on the baseline Orientation-Memory-Concentration Test done at baseline (Appendix E), a proxy/designee must then be assigned to help the patient fill out the questionnaires for the duration of the study in order to participate. The treating provider will also be notified about the cognitive impairment.
* Ability to provide informed consent

Exclusion Criteria:

* Pathological or clinical stage 0, IV disease
* Those with nodal or metastatic recurrences at the time of enrollment
* Unable to speak and read English AND no designee who speaks and reads English, as above
* Unable to provide informed consent
Effect of Muscular Energy Technique on Postural Control

The research aims to evaluate the immediate effect of the muscle energy technique (TEM) on postural control responses in the elderly and young adults. The sample will be selected for convenience, being participants of both sexes, young and old. Evaluation of postural control through the force platform will be performed during the unipodal and semi-tandem balance tests. The main parameters of postural control will be calculated using the pressure center derivative. After the balance tests, the participants will be submitted to TEM and immediately afterwards reassessed on the force platform.

Aging is considered a dynamic and progressive process, in which morphological, functional and biochemical changes occur. One of the factors associated with old age is the decrease in the ability to balance posture and the high risk of falls. The literature brings the benefits of physical exercise in improving balance and preventing falls. However, few studies point to the benefits of flexibility techniques and their relationship with balance. The objective of this research is to evaluate the immediate effect of the muscle energy technique (TEM) on postural control responses in the elderly and young adults. The sample will be selected for convenience, with 50 participants of both sexes, young people between 18 and 35 years old and elderly people between 60 and 85 years old. Evaluation of postural control will be performed through the force platform during the unipodal and semi-tandem balance tests (2 repetitions of 30 seconds each, with rest of 30 seconds between them). The main parameters of postural control will be calculated using the pressure center derivative. After the balance tests, the participants will be submitted to TEM and immediately afterwards reassessed on the force platform. An analysis of variance will be used to compare the effects between groups (young versus elderly) and intervention (pre- and post-TEM) and the effects of interaction on the main variables of postural control. A beneficial effect of TEM is expected, especially in the elderly group. The results found in this study will contribute to the use of TEM and the increase of relevant clinical information to benefit the ability to balance in the elderly, in order to reduce the risk of falls.

Eligibility Criteria:
Inclusion Criteria:

* Accepting to participate in a study on a voluntary basis;
* Aged between 18 and 35 years old for young adults and over 60 years old up to 85 years old for elderly people;
* Being physically independent;
* Not practicing regular physical activity as recommended by the ACSM 3 to 5 times a week with moderate and severe;
* Cognitive status\> 18 in the Mini-Mental State Examination.

Exclusion Criteria:

* Elderly with cognitive changes detectable by the Mini Mental State Examination (MMSE);
* A score lower than the score predicted for their level of education;
* Self-reported injuries;
* Falls in the last year;
* Musculoskeletal disorders;
* Systemic neurological-degenerative disease;
* Severe labyrinthitis and chronic diseases of the cardiovascular or respiratory system.
Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments

Background: Breast cancer (BC) treatments usually include a combination of surgery, chemotherapy and radiation. These life-saving treatments cause high percentages of arm morbidity, which often lasts for months, or develops months after surgery. Arm and shoulder morbidity includes prolonged pain, restriction of movement, limitation of function and lymphedema (chronic progressive edema). All of these morbidities affect the quality of life (QOL) of the recovering patients and require lengthy care. Early detection of patients at risk and provision of proactive treatment can improve the recovery process from surgery and oncology treatments.

Aim: To develop a screening tool for the early identification of women at high risk for prolonged arm morbidity following BC treatments (persistent pain, lymphedema, function deficits and decreased range of motion), validate the tool, and examine the efficiency of intervention based on the the use of the tool.

The development and the assessment of the screening tool will conduct in three stages:

1. Systematic review and meta-analysis to identify from the literature risk factors for lymphedema, prolong pain, decreased range of motion (ROM), quality of life (QOL) and function after breast cancer (BC) treatments and surgery. Intended to understand which factor could be included in the screening tool.
2. Development of the screening tool (study no. 1)- cross section study that will examine which of the risk factors found in the literature review/ meta-analysis will enter the tool. Women up to 3 years after BC surgery will be evaluated for arm morbidity (pain, lymphedema, limitation of movement and limitation of function), and their association to the risk factors, using an online questionnaire.
3. A small cohort study (study no. 2)- Aimed to validate the screening tool. The study will be conducted at the hospital's oncology institute, and will recruit BC survivors who come for routine follow-up six months till three years after surgery. Patients will be asked to answer an online questionnaire, in addition, limb volume tests, strength and ROM will be performed at the clinic. A comparison will be made between the physical parameters that indicate the morbidity of the arm and the score found in the screening tool.
4. A small prospective study (study no. 3)- The main goal of this study is to examine whether the use of the new questionnaire by the patients themselves will; A) affect the percentage of arrival to physical therapy (PT) treatments, B) will affect morbidity rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75
* Independent
* Speaking Hebrew and Russian

Exclusion Criteria:

* Patients who reported that from the time elapsed from the surgery they underwent additional surgery or an injury affecting the function/ pain of the arm.
* Patients suffering from advanced metastatic disease, or background diseases that limit function.
* Lymphedema prior to surgery.
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma

Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥65 years with newly pathologically confirmed NPC
* Karnofsky performance status ≥60
* Clinical stage III-IVA (Union for International Cancer Control and American Joint Committee on Cancer staging system for NPC, 8th edition)
* Adequate organ function

Exclusion Criteria:

* Cancer history
* Prior radiotherapy, cytotoxic chemotherapy, immunotherapy or target therapy
* Life-expectance within 6 months
A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors

The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0405 in patients with select advanced solid tumors.

This is a 2-part study. The Phase 1a will consist of a dose escalation of ADRX-0405 to evaluate initial safety and tolerability in patients with select advanced solid tumors \[including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC)\], and to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of ADRX-0405 in subjects with previously treated metastatic castration resistant prostate cancer (mCRPC).

Eligibility Criteria:
Inclusion Criteria:

* Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC).
* Phase 1b Dose Expansion: Subjects with histologically confirmed prostate adenocarcinoma that is confirmed to be castration resistant (i.e., serum testosterone \< 50 ng/dL \[\< 2.0 nM\]) and that is intolerant/resistant to standard of care (SOC) therapies.
* Measurable disease according to RECIST version 1.1 or evaluable disease per PCWG3 for subjects with prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 in 1a; 0-2 in 1b
* Adequate hematologic, liver, and renal function

Exclusion Criteria:

* Active and uncontrolled central nervous system metastases
* Significant cardiovascular disease
* History of another malignancy other than the one for which the subject is being treated on this study within 3 years
* Receipt of any anticancer or investigational therapy within: 5 elimination half-lives or 14 days (whichever is less); 4 weeks for any therapeutic radiopharmaceutical for prostate cancer
* History of (non-infectious) ILD/pneumonitis that required steroids within 2 years of study enrollment, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted
Effects of Chest Expansion Exercises on Thoracic Expansion and VO2 Max in Children With Chest Burn

Burns are injuries to the skin or tissues caused by heat, electricity, chemicals, friction, or radiation. They can result from flames, hot solids, or liquids. In intensive care, physiotherapy often includes sitting exercises, passive motions, and active training, which are essential for recovery after burns. This study aims to evaluate the impact of chest expansion exercises using a stretch pole on chest expansion and VO2 max in children with chest burns. Conducted as a quasi-experimental study at Jinnah Burn Centre in Lahore, it will involve 33 participants selected through non-probability convenience sampling. Data collection will span six months. Thoracic expansion will be measured with an inch tape, and VO2 max will be calculated using a specific formula. Routine physiotherapy, including range of motion exercises and soft tissue massage, will be administered alongside chest expansion exercises for 20 minutes daily, five days a week, over three weeks.

Burns are a kind of injury that can occur to the skin or other tissues. Acute trauma can be brought on by heat, electricity, chemicals, friction, radiation, or other factors. Burns are a kind of injury that can occur to the skin or other tissues. Acute trauma can be brought on by heat, electricity, chemicals, friction, radiation, or other factors. Burn are many types of burn Flames (flame burns), hot solids (contact burns), or hot liquids (scalds). Sitting out of bed, passive motions, and active/assisted exercises were frequent physiotherapy therapies in the intensive care unit. After a burn injury, exercise training serves as a significant and useful technique for achieving physical health. The objective of this study is to check the effect of chest expansion exercises by using stretch pole on chest expansion and VO2 max in children with chest burn. This study will be a Quasi-Experimental study .Data will be collected from Jinnah Burn Centre, Lahore. Data will be collected within 6 month from approval date of synopsis. Sample size is 33. Non-probability convenience sampling technique will be used in this study. Thoracic expansion will be measured by inch tape and vo2 max will be calculated by using a formula. Routine physiotherapy will be provided to the subjects routinely with chest expansion exercises. In routine physiotherapy, Range of motion exercises, Soft tissue massage, positioning to prevent the pressure sores will be provided for almost 20 minutes. The chest expansion exercises will be provided to the patients by using stretch pole for 20 minutes. All the interventions will be given to patients for 5 days in a week on daily basis for 3 weeks

Eligibility Criteria:
Inclusion Criteria:

* Age: 5- 10 years.
* Children with mild to moderate chest burn.
* Children with decreased mobility due to chest burn.

Exclusion Criteria:

* Chest burns with any post-burn complications,
* Neurological impairments,
* Contracture due to immobility,
* Infection due to chest burn.
An Open Label Extension of a Study Comparing Topiramate and Amitriptyline in Migraine Prevention.

The purpose of this study is to assess the long-term safety and effectiveness of topiramate for the prevention of migraine headaches in adults. Topiramate has been approved to prevent migraine headaches in adults.

Migraine headaches can be disabling and can interfere with work and a person's quality of life. Preventing these headaches before they start is the best option. Topiramate, an anti-seizure medication, has been shown to help prevent migraine headaches from occurring. This is an open-label study that is an extension of a previous study (CAPSS-277) comparing topiramate and amitriptyline in migraine prevention. It includes patients who completed the previous study and elected to enter open label treatment with topiramate. The study will involve a 4-week Blinded Transition Phase during which patients will be titrated up to a daily topiramate dose of 100 milligrams (or the maximum tolerated dose, whichever is less). Then there will be a 12-week Open-Label Maintenance Phase during which the topiramate dose may be adjusted according to effectiveness and tolerance, but not to exceed a daily dose of 400 milligrams. While on topiramate, patients will record daily entries in their headache records. Patients will be asked questions to help assess their quality of life. Patients will also have physical examinations and laboratory tests performed during the study. The objective of this study is to evaluate the long-term safety and effectiveness of topiramate for the prevention of migraine headaches.

Topiramate oral tablets, 25 milligrams per tablet, will be given in the morning and evening to a dose not to exceed 400 milligrams per day or to the maximum tolerated dose, whichever is less

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine with or without aura
* Successfully finished CAPSS-277 study
* In generally good health
* Able to take medicine orally
* If female, using birth control

Exclusion Criteria:

* Not having a more painful condition than the headache pain
* Cannot be taking any other medications not allowed by the study
* Abnormal liver tests
* Not compliant with study medication during the CAPSS-277 study
* Pregnant or breast-feeding
CoolSculpting System

Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the purpose of non-invasive fat reduction.


Eligibility Criteria:
Inclusion Criteria

* Subject (healthy volunteer) has read and signed the study written informed consent form.
* Male or female ≥ 22 years and ≤65 years of age.
* Subject has clearly visible fat in one or more areas on the torso (abdomen, flank, back fat, bra fat), which in the investigator's opinion, may benefit from the treatment.
* Subject has not had weight change exceeding 5% of body weight in the preceding month.
* Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the study.
* Subject has a BMI ≤ 30 as determined at screening.
* Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.

Exclusion Criteria

* Subject has had a recent surgical procedure in the area of intended treatment.
* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
* Subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has a known history of cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold agglutinin disease.
* Subject has a known sensitivity to cold, such as cold urticaria, Raynaud's disease, chilblains (pernio), or any known condition with a response to cold exposure that limits blood flow to the skin.
* Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* Subject is taking or has taken diet pills or supplements within the past month.
* Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
* Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
* Subject has a history of hernia in the area(s) to be treated.
* Subject is pregnant or intending to become pregnant during the study period (in the next 8 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any unapproved investigational drug or device.
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP)

Modic changes are associated with low back pain (LBP) both in clinical and general population-based samples. Type I changes are regarded as more likely to be painful than type II changes. Several studies suggest that type I changes are inflammatory in nature.

So far, no treatment exists for LBP due to Modic changes. Bisphosphonates could be effective in this specific low back disorder through two mechanisms: 1) they could consolidate vertebral bodies thereby improving the tolerance for mechanical load and 2) they could diminish inflammation as observed recently in case of ibandronate in an experimental model.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old
* low back pain for more than 3 months
* Modic type I or II change in lumbar magnetic resonance imaging
* Intensity of low back pain at least 6 on 10-cm VAS or Oswestry disability score at least 30%

Exclusion Criteria:

* premenopausal female patients with possibility of pregnancy
* patients with calculated creatinine clearance of less than 40 ml/min
* patients with hypocalcemia
* patients with known hypersensitivity to zoledronic acid or other bisphosphonates or ingredients of the infusional product
* patients with red flags symptoms
* patients with nerve root impingement
* patients with willingness for early retirement
Nutraceutical on Hyperglycemia

The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dysglycemia.

The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dysglycemia.

The investigators will enroll patients with impaired fasting plasma glucose (IFG) or impaired glucose tolerance (IGT), not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents). Patients will be randomized to take placebo or Glicoset® 1000 for 3 months, in a randomized, double-blind, placebo-controlled design. Glicoset® 1000 and placebo will be self-administered once a day, 1 tablet during the breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT)
* Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)

Exclusion Criteria:

* Patients with type 1 or type 2 diabetes mellitus
* Patients with impaired hepatic function
* Patient with impaired renal function
* Patients with gastrointestinal disorders
* Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
* Patients with weight change of \> 3 Kg during the preceding 3 months
* Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
* Patients taking (within the previous 3 months) hypoglycemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, anti-depressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics
* Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.