cyrilzakka/clinical-trials huggingface dataset:
Muscle Energy Technique Versus Maitland Mobilization on Shoulder Pain and Disability

The purpose of this study was to investigate the effect of muscle energy technique versus Maitland's mobilization on shoulder pain and disability after neck dissection surgeries.

Thirty patients with shoulder pain and limited ROM post-neck dissection surgeries participated in this study. Patients were subdivided into two groups, fifteen patients in each group. Group A received the muscle energy technique and group B received Maitland's mobilization.

Data obtained from both groups regarding the Visual Analogue Scale, it has a 100-mm-long horizontal line labeled ''no pain' (with or without related facial expressions) at one extreme and ''worst pain ever' at the other. Pain intensity is determined by the length of the line as measured from the left-hand side to the point marked, The Shoulder Pain and Disability Index, it has two subscales; The pain subscale includes five questions about pain intensity. The disability subscale includes eight questions about difficulty in different orders. Each question of both pain and disability subscale was scaled in numeric ratings ranging from 0 to 10. Each score was summed up and transformed into percentages. Finally, the average score between pain and disability subscale comprised the total SPADI scores ranging from 0 (the best) to 100 (the worst), and shoulder flexion, abduction, and external ROM were statistically analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 25-70 years.
* Male and female patients participated in the study.
* All patients had shoulder pain following different NDS
* All patients had no previous shoulder pain.
* All patients enrolled in the study had their informed consent.

Exclusion Criteria:

* Previous shoulder pain from any other causes.
* Pregnancy.
* Epileptics.
* Radiotherapy.
* Chemotherapy.
A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)

This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.

This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* For Phase I the subject has histological or cytological evidence of a solid tumor. For Phase II the subject must have 1 of the specified adult solid tumor types: gastric, ovarian, lung, head and neck.
* Subject must have at least one target lesion based on RECIST
* Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
* Subjects must have adequate liver function
* Subjects must have adequate kidney function
* Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery
* Subjects who have received radiation therapy must wait at least 4 weeks after their last radiation treatment before enrollment into the study
* Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered
* Subject will agree to follow contraceptive requirements defined in the protocol
* Additional criteria may apply

Exclusion Criteria:

* Subject is currently pregnant, planning to become pregnant, or breastfeeding
* Subjects with an active infection or with a fever ≥ 38.5°C within 3 days of the first scheduled day of dosing for Cycle 1
* Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks, and the subject is neurologically stable
* Subjects with known hypersensitivity to any components of ALKS 4230 or to pembrolizumab or any of its excipients
* Subjects who require pharmacologic doses of systemic corticosteroids are excluded; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
* Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and/or neuropathy
* Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subjects to cooperate and participate in the study
* The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis
* Additional criteria may apply
Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2

RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer.

OBJECTIVES:

* Determine the percentage of patients with stage IV renal cell carcinoma with a reduction in tumor size after treatment with B7-1 gene-modified autologous tumor cell vaccine and interleukin-2.
* Determine the immunogenicity of this regimen in these patients.
* Determine the overall survival of patients treated with this regimen.
* Determine the local and systemic toxicity of this regimen in these patients.

OUTLINE: Tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis.

At approximately 3-6 weeks after surgery, patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously (SC) once on days 1, 29, and 57. At 6 weeks after the first vaccination, patients receive interleukin-2 (IL-2) SC five days a week for 6 weeks (days 43-82). Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks after the last dose of IL-2.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage IV renal cell carcinoma

  * Symptomatic primary tumor or resectable metastasis
* Measurable disease post resection
* No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Eastern Cooperative Oncology Group (ECOG) 0-1

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 4,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 10 g/dL
* Hematocrit greater than 30%

Hepatic:

* Bilirubin less than 2 times normal
* SGOT less than 3 times normal

Renal:

* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Cardiovascular:

* No evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No contraindications to surgical resection
* No history of immunodeficiency disease
* No known allergy to penicillin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior interleukin-2, interferon alfa, or other biologic agent allowed

Chemotherapy:

* Not specified

Endocrine therapy:

* No concurrent corticosteroids (except for replacement doses for adrenal insufficiency)

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* No concurrent immunosuppressants
The Value of ctDNA on Chemotherapy Efficacy for mCRC

The study is designed to evaluate the value of ctDNA in predicting the drug efficacy of chemotherapy for metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months at least one measurable metastatic lesion have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection
An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System

The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.


Eligibility Criteria:
Inclusion Criteria:

* Dysfunctional immune system (reduced neutrophils).
* Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection.
* Male of female ≥16 years of age.
* Expected hospitalization for at least ten (10) days.

Exclusion Criteria:

* Pregnancy or breast feeding or planning to become pregnant during the study.
* Recent treatment with one of the study drugs over the last 30 days.
* Allergy to either study drug or to this class of drugs.
* Significant liver dysfunction.
* Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.
Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy

This study was done to determine if the use of a combination of preoperative rectal misoprostol 400µg used with intraoperative perivascular vasopressin is better than perivascular vasopressin used alone to decrease bleeding at myomectomy.

A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus. This procedure can be associated with significant blood loss which can result in significant morbidity and mortality. The drug misoprostol which has been been use in the treatment of postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective myomectomy at the University hospital of the West Indies and from the private practice of the participating doctors who were invited to participate in the study. Patients were randomized to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before surgery. Twenty five patients received misoprostol and twenty patients did not.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.

Exclusion Criteria:

* patients who have had previous myomectomy or previous pelvic surgery.
* patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease.
* patients who refuse to participate or give consent to the procedures. Patients with a known allergy to any of the study drugs.
Upper Airway Training for Treatment of Snoring

The objective of this study is to reduce the incidence or intensity of snoring in a patient population of known simple snorers without sleep apnea using smartphone based application which allows participants to play voice controlled games using various articulations resulting in tongue base movements.


Eligibility Criteria:
Inclusion Criteria:

1. Fluent in English.
2. Age is between 20 and 65.
3. BMI less than 32
4. Less than 5% variance in weight since sleep study.
5. Snoring without health risk related to sleep apnea and not currently receiving treatment.

   1. Mild OSA or negative HSAT or PSG within past year with AHI 0-14
   2. Has refused oral appliances, CPAP, weight loss, surgery or positional therapy.
6. Owns an iPhone 4 or newer and is comfortable downloading and using apps.
7. Complaint of habitual snoring 3 or more nights per week
8. Rated by polysomnograph technologist as moderate or loud snoring.

Exclusion Criteria:

1. Non-fluent in English.
2. Persistent rhinitis diagnosis or nasal obstruction.
3. BMI \> 32
4. Greater than 5% variance in weight since sleep study.
5. Diagnosis of moderate to severe sleep apnea or any other sleep disorder (insomnia, RLS)
6. Insufficient sleep, defined as getting fewer than 6 hours of sleep on an average night based on self report.
7. Spouse/partner is also a habitual snorer.
8. Lacking ability to consent for themselves.
9. Heavy drinker (self reported average more than 2 drinks per day).
10. Regular narcotics (greater than 3 times/week)
11. Epworth sleepiness scale score \> 11 or one near miss accident in the past 6 months.
12. Medical conditions as follows: symptomatic cardiopulmonary disease, chronic renal insufficiency, poorly controlled mental illness.
Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms in Home Care Services

Continuity of care in home care services is necessary to facilitate the assessment and treatment of persons with dementia and cognitive failure. TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. The trial is designed to assess the effects of TIME on Neuropsychiatric symptoms for persons (NPS) with dementia in home care services.

The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. TIME consists of a manual based multicomponent program which includes a rigorous assessment, treatment, and the evaluation of neuropsychiatrc symptoms (NPS).

The cluster RCT will contain two parallel groups, where randomisation is performed based on clusters. One municipality is one cluster, randomized to receive either the intervention with TIME or a brief two hours education-only intervention about dementia and NPS for the control group. Totally 10 municipalities will be included. Data will be collected at baseline before randomisation and at the end of the implementing phase. Measurements at patient level are taken at baseline prior to randomization and after 6 months. The primary outcome measure is difference in change between the intervention group and the control group from baseline to follow up at 6 months in the Cornell Scale for Depression in Dementia (CSDD).

Data collection will be performed by project nurses recruited outside the home care services. They will interview the staff or family members who knows the patient best. The assessors will be blinded to the randomization of the home care services. Interviews will be done by telephone or face-to-face, depending on what is best for the person interviewed.

After the intervention focus group interviews with staff and family members will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Dementia, defined as a score of 1 or more on the Clinical Dementia Rating Scale (CDR)
* A minimum of 15 minutes of home care services per day for the last 4 weeks
* NPS, defined as a score on the NPI-NH affective subsyndrom (NPI depression + NPI anxiety) of 12 or more
* Informed consent from the participant or family or next-of-kin

Exclusion Criteria:

* Terminal disease
Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children

Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or without adenoidectomy may be as high as 75%.

Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments:

* dexamethasone alone (250 mcg/kg)
* dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)
* dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).

Tonsillectomy with or without adenoidectomy may be associated with severe postoperative nausea and vomiting (PONV). Causes are principally trigeminal nerve stimulation and presence of blood in the stomach. Consequences are disagreement, unsatisfactory, delayed discharge, and overnight admission in day-cases. More barely, patients may also have suture and esophagus rupture, aspiration of gastric contents, dehydration and electrolyte disturbances.

Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments:

* dexamethasone alone (250 mcg/kg)
* dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)
* dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).

The hypothesis is that the combination of dexamethasone and droperidol is as effective as the combination of dexamethasone and ondansetron, both of them being more effective than dexamethasone alone. Moreover, droperidol is cheaper than ondansetron and may be recommended as a first-line treatment.

Eligibility Criteria:
Inclusion Criteria:

* children aged 2-10 y.
* children ASA 1-2
* weight \> 15 kg
* tonsillectomy with or without adenoidectomy

Exclusion Criteria:

* intravenous induction
* contraindication to steroids
* contraindication to antidopaminergic drugs
* contraindication to serotoninergic antagonists
* administration of steroids, antidopaminergic drugs, or serotoninergic antagonists in the 24 hours before the surgery
* refusal of parents
* no-french speaking parents
Electronic Patient-reported Outcome Monitoring in Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria

Aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) are interrelated and very rare diseases. Therefore, little data about clinical characteristics, especially the variety of symptoms in the course of the respective disease are available. As a consequence, patients may be left on their own between infrequent follow-ups at a specialist center. A web-based symptom-monitoring application can support selfmanagement and patient empowerment and promotes a patient- centered interdisciplinary team approach in the context of a "disease management program". This pilot study is to investigate usability and feasibility of the electronic Patient-Reported Outcome (ePRO) application in AA/PNH by assessing recruitment, app utilization, data collection, functionality, acceptability after using and working with the ePRO application.


Eligibility Criteria:
Inclusion Criteria:

* AA (acquired and hereditary) and/or PNH patients
* Minimal level of computer literacy with prior email experience and access to an Internet connection

Exclusion Criteria:

* Mental alteration or psychiatric disease that can compromise written informed consent or adherence to the protocol and monitoring of the trial
Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)

Long-term follow-up studies have demonstrated significant late toxicities of total body irradiation (TBI), which are most marked in children radiated at a young age. Growth failure, decline in cognitive function, and endocrine abnormalities have all been described. Good outcomes can be achieved with alkylating agents only as a preparative regimen. This plan will use a combination of busulfan and cyclophosphamide (Bu/Cy) with or without antithymocyte globulin (ATG) to reduce the late toxicities of therapy that includes TBI.


Eligibility Criteria:
Inclusion Criteria:

* Suitable cord blood from matched unrelated or related donor.
* Cardiac (Echo/EKG): shortening fraction ≥ 27%
* Electrolytes within normal CCHMC limits.
* Pulmonary function tests: DLCO ≥ 50%
* Renal: creatinine clearance/GFR ≥ 60 ml/minute/1.73m2
* Lumbar puncture: no leukemic infiltrate.
* CBC: ANC ≥ 1000ml and unsupported platelet count of ≥ 50,000/ml
* Documented HSV and CMV titers, Hepatitis B surface antigen, Hepatitis C by serology, HIV by serology: all negative.
* Hepatic transaminases \< 2.5x normal; Total bilirubin \< 2 mg/dl Patients who do not meet above organ function criteria (liver, cardiac, renal), due to the presence of a tumor compromising these organs, may have exception made for these criteria and remain eligible for treatment plan after consultation with Program Director of Blood and Marrow Transplant

Exclusion Criteria:

* Patients with neoplastic or non-neoplastic disease of any major organ system that would compromise their ability to withstand the pre-transplant conditioning regimen.
* Patients with uncontrolled (culture or biopsy positive) infections requiring intravenous antivirals, antibiotics, or antifungals. Patients on prolonged antifungal therapy with a history of fungal infection should be considered for a non-myeloablative protocol.
* Patients who are pregnant or lactating. Patients of childbearing potential must practice an effective method of birth control while participating on this treatment plan.
* HIV seropositive patients
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I

To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease


Eligibility Criteria:
Inclusion criteria:

1. Signed informed consent prior to participation.
2. Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) \<80% of predicted normal and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec)/FVC of \< 70% at Visit 1.
3. Male or female between 40 and 75 years of age.
4. Current or ex-smokers with smoking history of more than 10-pack years.
5. Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records.
6. Able to inhale medication in a competent manner from a metered-dose inhaler and Respimat inhaler.

Exclusion criteria:

1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT \>x2 ULN, SGPT \>x2 ULN, bilirubin \>x2 ULN or creatinine \>x2 ULN.
2. Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3.
3. Patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute).
4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse or contraindications to exercise.
5. Patients who have undergone thoracotomy with pulmonary resection.
6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
7. Patients who regularly use daytime oxygen for more than one hour per day.
8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
9. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea.
10. Pregnant or nursing women.
11. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).