cyrilzakka/clinical-trials huggingface dataset:
Comparative Clinical Trial: Manual Therapy with and Without Radial Extracorporeal Shockwave Therapy to Treat Acute Low Back Pain

The goal of this clinical trial is to learn if the addition of radial pulse therapy to chiropractic care will help adult patients recover faster to an acute bout of low back pain. Radial pulse therapy is the application of acoustic waves that passes through the skin to tissues and cells in the body. The main questions that the clinical trial aims to answer are:

* Does the addition of radial pulse therapy to chiropractic care result in better or earlier reduction in pain intensity?
* Does the addition of radial pulse therapy to chiropractic care result in better or earlier improvement in physical function?

Researchers will compare radial pulse therapy plus chiropractic care to chiropractic care alone to see if patients with acute low back pain recover faster with the addition of radial pulse therapy.

Participants will:

* Visit the clinic once a week for 5 weeks
* Receive chiropractic care with or without the addition of radial pulse therapy to the low back and hip regions of the body
* Report their pain intensity and perform a physical function test at each clinic visit


Eligibility Criteria:
Inclusion Criteria:

1. Biological sex of male or female
2. Age Range: 18 to 40 years old
3. Diagnosis of acute mechanical low back pain (\< 3 months duration)
4. Pain intensity \> 3 on the 11 point NPRS with 0 "being no pain at all" to 10 "being worse pain possible" within the context of either "right now" or "at its worst during the past 7 days"

Exclusion Criteria:

1. Subjects who are currently using over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen (Advil, Motrin) and naproxen (Aleve), or prescription NSAIDs to manage any medical condition.
2. Subjects who used oral corticosteroids that are only available by prescription to manage any medical condition within the past 6 weeks.
3. Subject who received a corticosteroid injection for any medical condition within the past 6 weeks.
4. Subjects who are not willing to be randomly assigned to either of the treatment interventions.
5. Subjects with open wounds to the lower and mid back that will prevent the application of radial ESWT.
6. Subjects with hypermobility and/or instability of the lower and mid back, which are contraindications for manual therapy.
7. Subjects who have a case history of low back pain episodes, e.g., chronic or persistent occurrence of low back pain.
8. Subjects who do not meet the differential diagnosis of acute mechanical low back pain, i.e., origin of their back pain is unknown or non-specific to a low back structure.

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Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as pilocarpine may protect normal cells from the side effects of radiation therapy. It is not yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.

PURPOSE: Randomized, double-blinded, phase III trial to study the effectiveness of pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.

OBJECTIVES: I. Determine whether prophylactic use of pilocarpine can shelter unstimulated and stimulated whole salivary flow in patients with head and neck cancer. II. Determine whether prophylactic use of pilocarpine can moderate xerostomia in these patients. III. Determine whether prophylactic use of pilocarpine can reduce the grade and duration of radiation induced mucositis in these patients. IV. Evaluate quality of life outcomes between patients receiving pilocarpine versus placebo. V. Evaluate the impact of xerostomia on patients receiving irradiation to the head and neck.

OUTLINE: This is a randomized, double blind study. Patients receive a central axis midplane dose of radiotherapy five days per week over 6 to 7 weeks. Oral pilocarpine or placebo is administered beginning 3 days prior to radiotherapy, one tablet four times per day for three months. A tablet will be taken 45-60 minutes before radiotherapy. After three months, and after a 3-4 day rest period, all patients receive non blinded pilocarpine for an additional three month period. Patients are followed at weeks 4, 13, and 26 after the start of radiotherapy.

PROJECTED ACCRUAL: A total of 244 patients will be accrued (122 per treatment arm).

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven oral cavity and/or oropharyngeal squamous cell carcinoma Radiation volume to encompass at least 50% of parotid glands and have at least 50 Gy delivered to that volume via external beam No salivary gland malignancies or diseases

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 60-100% Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Effective contraceptive method must be used during study No pilocarpine allergy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head or neck Surgery: Not specified Other: No concurrent adrenergic antagonists, cholinergic drugs, anti-cholinergics, or tricyclics
Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion


Eligibility Criteria:
Inclusion Criteria:

* single dead fetus up-to 12 weeks.
* no low lying placenta
* no scarred uterus
* no or mild bleeding
* no evidence of infection
* accepting to participate in the study.

Exclusion Criteria:

* Advanced hepatic diseases .
* Suspected molar pregnancy
* Ectopic pregnancy or pregnancy of unknown location
* Haemodynamically unstable with significant anaemia ie Hb\<10
* Uncontrolled severe asthma
* Chronic adrenal failure
* Known or suspected heart disease
* Glaucoma
* Haemoglobinopathies
* Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
* Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
* Patient living in remote areas with difficulty in accessing hospital
Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients

The purpose is to test whether daily ischemic conditioning of the arms over 30 days could reduce the frequency and severity of angina pectoris and improve the life quality of refractory angina pectoris patients.

Refractory angina pectoris denotes "chronic stable angina that persists despite optimal medication and when revascularisation is unfeasible or where the risks are unjustified". These patients could potentially be relieved by non-conventional treatments like remote ischemic conditioning, and actually this effect has been observed in several cases in the center of the sponsor. This study is a pilot study to measure the efficacy and safety of this method in this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed angina pectoris that remains despite optimal medical treatment;
* No chance of further revascularization or refusal to do revascularization;
* The frequency and Canadian Cardiovascular Society (CCS) scale stays stable over the past 3 months before inclusion.

Exclusion Criteria:

* Known or highly suspected abnormality of peripheral arteries, veins, or extremities;
* Infection or fever in the past month;
* Blood pressure over 180/110 millimeters of mercury (mmHg) or below 80/50mmHg;
* Refusal to comply with the study protocol;
* Currently under sulfonylureas or prostaglandins therapy;
* Other conditions that the researchers judge as inappropriate to participate.
Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

The objective of this study is to compare the effectiveness of olanzapine added to standard triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients receiving highly or moderately emetogenic chemotherapy regimens.

Nausea and vomiting remains a common and difficult to manage consequence of chemotherapy despite prophylaxis. These symptoms can often lead to a decreased quality of life, dehydration, and malnutrition. Olanzapine is an atypical antipsychotic that blocks multiple neuronal receptors involved in nausea/vomiting pathways. Olanzapine has been studied for breakthrough chemo-induced nausea and vomiting (CINV) as well as in prophylaxis of highly and moderately emetogenic regimens (HEC and MEC, respectively). However, these studies have focused on patients with solid tumor malignancies and chemotherapy regimens of short duration. To date, no publications have reported outcomes from adding olanzapine to standard triplet therapy, for hematology patients, including those undergoing hematopoietic stem cell transplants and those who receive multi-day HEC and MEC regimens.

This is a blinded, placebo controlled trial randomizing patients to receive olanzapine 10 mg orally on all chemotherapy days plus three additional days post chemotherapy or placebo in addition to standard triplet therapy (ondansetron and dexamethasone on each day of chemotherapy and fosaprepitant 150 mg IV on day one of chemotherapy). Inclusion criteria: age 18 or older, receiving inpatient or outpatient HEC or MEC chemotherapy including those regimens given before stem cell transplantation (ABVD, ICE ± R, 7+3 or 5+2, BEAM, Bu/Cy ± ATG, Bu/Flu ± ATG, FluCy ± ATG, BuMel, FluBuCy, Melphalan). Exclusion criteria: allergy to olanzapine, documented nausea/vomiting ≤24 hours before enrollment, treatment with other antipsychotic agents, or declined informed consent. Patients will be randomized to placebo or olanzapine in a block design stratified by chemotherapy type (transplant conditioning vs. chemotherapy only) and number of days of chemotherapy (single vs. multi-day) by the Investigational Drug Pharmacy services at Augusta University Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient or outpatient hematology patient receiving one of the following regimens:
* Chemotherapy for hematologic malignancy:
* ABVD
* ICE ± R
* 7+3
* Conditioning therapy for stem cell transplantation:
* BEAM
* Bu/Cy ± ATG
* Bu/Flu ± ATG
* FluCy ± ATG
* FluCy + TBI
* BuMel
* FluBuCy
* Melphalan
* Etoposide + TBI
* Cyclophosphamide + TBI

Exclusion Criteria:

* Allergy to olanzapine
* Documented nausea or vomiting ≤24 hours prior to enrollment
* Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to enrollment or planned during protocol therapy
* Chronic alcoholism
* Pregnant
* Declined or unable to provide an informed consent
Evaluation of Efficacy and Safety of E004 in Children With Asthma

This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo HFA-MDI in pediatric patients who are 4-11 years of age with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy male, and premenarchal female, children aged 4 - 11 years upon Screening.
* With documented asthma, requiring inhaled epinephrine or beta2-agonist treatment, with or without concurrent anti-inflammatory therapies for at least 6-months prior to Screening.
* Being capable of performing spirometry for FEV1
* Satisfying criteria of asthma
* Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods
* Demonstrating a Screening Baseline FEV1 that is 50 - 90% of Polgar predicted normal value.
* Demonstrating an Airway Reversibility,
* Demonstrating satisfactory techniques in the use of a metered-dose inhaler (MDIs) and a hand held peak expiratory flow meter, after training.
* Has been properly consented to participate in this study.

Exclusion Criteria:

* Any current or past medical conditions that, per investigator discretion, might significantly affect pharmacodynamic responses to the study drugs
* Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
* Known intolerance or hypersensitivity to any component of the study drugs
* Recent infection of the respiratory tract
* Use of prohibited medications
* Having been on other investigational drug/device studies in the last 30 days prior to screening.
Investigating Exercise in Myotonic Dystrophy Type 2 (DM2)

An exercise regimen (PRIME: Proximal Resistance In-House Movement Exercise) has been designed for patients with myotonic dystrophy type 2 (DM2). The hypothesis is that this patient-friendly physical therapist (PT)-guided exercise program associates with improved functional capacity and muscle composition in DM2 in this two-period two-sequence cross-over study. Thus, participant will be randomized to one of the three possible groups. Participants in GROUP A will perform exercise routine in clinic under the direct supervision of a physical therapist twice a week for the first three months, then they will continue with same exercise routine at home for the last 3 months on their own. Participants in GROUP B will perform exercise routine virtually under the direct supervision of a physical therapist twice a week for the first three months, then they will continue with same exercise routine at home for the last 3 months on their own. Participants in GROUP C will perform exercise routine on their own during the first 3 months, then they will perform exercise routine virtually under the direct supervision of a physical therapist. Each group will include around 8 participants. Duration of the study is 6 months. In addition to exercise sessions, participants will have evaluation of their strength, motor function and muscle composition at three time points: initiation, 3 months and completion of the study at 6 months. Muscle composition will be assessed by electrical impedance myography which is a portable, non-invasive, painless and non-radiation tool that applies a weak high multifrequency electrical current to the examined muscle and allows to obtain information about its composition.


Eligibility Criteria:
Inclusion Criteria:

* Patients with genetically confirmed myotonic dystrophy 2 (DM2) who are ≥18 and ≤ 70 years old.
* Patients are ambulatory without need of any assistance or device.
* Patients have a normal ECG within the 3 months prior to Screening visit (of note, patients with DM2 are recommended to have routine ECG as part of patient care. So, this ECG will be done as part of patient care).
* Body mass index (BMI) ≥20 and ≤30.

Exclusion Criteria:

* Subjects younger than 18 years old or older than 70 years old.
* Inability or unwillingness of the subject to give written informed consent.
* Subjects with pacemaker.
* Blood pressure \<90/50 mmHg or \>160 mmHg/90 mmHg at Screening visit
* Resting heart rate of \<60 or \>100 beats/minute at Screening visit.
* Any fall within the last six months.
* Any history of syncopal episodes or family history of sudden death.
* Patients who are pregnant or plan to become pregnant. A urine pregnancy test will be performed at visit 1 and 3 for women of childbearing age. If positive or if subject is planning to become pregnant, subject will be not eligible for the study.
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years

Exclusion Criteria:

* Evidence or history of clinically significant disease
Corticoids in Severe Community-Acquired Pneumonia (CAP)

The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects, showing a benefit in the percentage of non-response to the empiric antimicrobial treatment.

Community acquired pneumonia (CAP) is associated with a local and systemic inflammatory response conducted by different pro and counter inflammatory cytokines. The evolution of the infection is mainly dependent on the intensity of the inflammatory response. The AIM of the project is to determine the clinical usefulness of methylprednisolone treatment (0,5 mg/ Kg weight every 12h for 5 days in patients with severe CAP and an excessive inflammatory response( patients identified based on a cut-off point of the reactive C protein (RCP) of 15 mg/dl). A randomized double blind placebo controlled study with two arms will be performed: The study group (patients with excessive inflammatory response) will receive methylprednisolone + antibiotics. Control group will receive placebo + antibiotics. Patients older than 18 years with Fine V pneumonia will be recruited. Clinical data and prognostic factors (APACHE II and, SOFA scores, etiology, mortality at ICU and at 28 days) will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Severe community-acquired pneumonia Fine V
* CRP \>=15 mg/100 mL

Exclusion Criteria:

* Major contraindications for corticosteroids, such as uncontrolled diabetes, immunosuppression
* Previous glucocorticoid treatment during the previous month
* Documented extrapulmonary infection
* Previous hospitalization in the previous month
F18-MHF: Orthopedic Implants-Associated Infection Detection

Following intravenous injection of \[F-18\]MHF as a bolus, dynamic PET imaging of the lower limbs will be acquired for approximately 90 minutes. The acquired images will be processed and viewed on a MIMVista or similar workstation. The uptake pattern of \[F-18\]MHF around infected orthopedic knee implant will be determined and compared with its uptake pattern around non-infected knee implants.

This study will look at how \[18F\]MHF goes into normal knee replacements and those with suspected infection.

This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to bacterial infections. The substance is called \[18F\]MHF and it is given in the form of an injection into a vein. After the substance reaches the infected body region, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called \[18\]FDG is used for PET scans to detect bacterial infections but this substance can't distinguish between bacterial infections and inflammation. This substance called \[18F\]MHF does not go to inflamed tissue and may allow bacterial infections to be seen better.

This study will look at how \[18F\]MHF goes into normal knee replacements and those with suspected infection. This will hopefully lead to the development of better imaging techniques to look at bacterial infections. \[18F\]MHF is approved by the FDA (Food and Drug Administration) for research.

Eligibility Criteria:
Inclusion Criteria for symptomatic patient cohort

* Patients must be 18 years of age or older, able to provide written informed consent, and ability to lie still for PET scanning.
* Suspected knee prosthetic infection at least 2 months after original prosthesis placement and who are scheduled to undergo surgery debridement/removal based on the clinical assessment of the referring surgeon.
* Elevated CRP and ESR

Exclusion Criteria for symptomatic patient cohort:

* Undergoing current or recent antimicrobial therapy (within 1 month)
* Significant comorbidity such as renal failure, septic shock, uncontrolled diabetes
* Other clinically likely site of infection

Inclusion Criteria for asymptomatic cohort:

* Patients must be 18 years of age or older, able to provide written informed consent and ability to lie still for PET scanning
* Knee prosthesis in situ without complications for 6 months or longer

Exclusion Criteria for asymptomatic cohort:

* Clinical or laboratory suspicion of knee prosthesis infection
* Recent (within 3 months) or current treatment for infected knee prosthesis
* Significant comorbidity such as renal failure, septic shock, uncontrolled diabetes
Synaptic Plasticity and Cognitive Function in RASopathies

The project is targeting cognitive impairment, one of the main health problems of patients with RAS pathway disorders. The aim of this study is to translate findings of animal studies to humans. This has been done by the applicants successfully for Lovastatin in Nf1. This result will be transferred to patients with Noonan Syndrome. lamotrigine is most likely a more effective and promising substance improving synaptic plasticity and consecutive cognitive function. It is expected that both substances are improving synaptic plasticity as well as alertness and changes in alertness may be a precondition for improvement of cognition.


Eligibility Criteria:
Inclusion Criteria:

1. Group 1: NS, Group 2: NF1 (both genetically assured)
2. Age ≥16 years
3. The adolescent (≥16) and legal guardian who are capable to give their consent and understand the aim and rationale of the study. In case of doubts, an independent medical practitioner will evaluate the capacity to consent.
4. Signed informed consent if ≥ 16 years and legal guardian.
5. Persons who are ≥ 18 years old and capable to give their consent and understand the aim and rationale of the study. In case of doubts, an independent medical practitioner will evaluate the capacity to consent.
6. Signed informed consent if ≥ 18 years.
7. Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country.

Exclusion Criteria:

1. Epilepsy
2. Medication with known CNS effects
3. Severe mental retardation
4. Side effects during previous medication with and contraindications for LTG and/or LOV and/or TMS
5. Psychiatric diseases
6. Previous history of allergic reactions with LTG and LOV medications
7. Potentially unreliable patients
8. Patients who are not suitable for the study in the opinion of the investigator
9. Pregnancy (incl. positive urine pregnancy test)
10. Persons who are incapable of giving consent or do not understand the aim or rationale of the study.