cyrilzakka/clinical-trials huggingface dataset:
ELECTROMAGNETIC FIELD ON NECK PAIN AND PROPRIOCEPTION IN CERVICAL RADICULOPATHY

PURPOSE:

to investigate effect of electromagnetic field therapy on neck pain and proprioception in cervical radiculopathy patients

BACKGROUND: Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders

Thirty four patients with cervical radiculopathy The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. The evaluation methods by Visual analogue scale for pain (VAS-P), cervical joint position error test (JPET), Neck disability index , and Cervical range of motion (CROM) goniometer device measurements

Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 30:45
2. Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
3. With mild to moderate cervical disability according to neck disability index
4. Body mass index (18.5 to 29.9) Kg/m2.

Exclusion Criteria:

1. Cervical myelopathy.
2. Patients with previous cervical surgery.
3. Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis
4. Any other musculoskeletal disorders of the spine or upper extremity.
Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers

The purpose of this study is to determine whether cabergoline is effective in reducing the incidence and severity of Ovarian Hyperstimulation Syndrome (OHSS), especially for severe cases; and to derive biomarkers for the risk of developing OHSS.

Severe ovarian hyperstimulation syndrome (OHSS) occurs in up to 2% of in-vitro fertilisation (IVF) cycles, resulting in accumulation of fluid in peritoneal, pleural and pericardial cavities, haemo-concentration with resultant venous thromboembolic phenomena, reduced perfusion of vital organs, renal failure, acute respiratory failure, and even death.

The long term aim is to develop a comprehensive strategy in reducing the incidence and severity of OHSS in in-vitro fertilisation (IVF) cycles. Our short term aim (2-3 years) is to test the ability of the dopamine receptor agonist cabergoline in reducing the incidence and severity of OHSS in high risk women undergoing controlled ovarian hyperstimulation (COH) in fresh IVF cycles through a reduction in vasoactive cytokine levels, specifically in serum vascular-endothelial growth factor (VEGF).

Specifically we will:

1. Conduct a randomised double-blind placebo-controlled trial in women at high risk of developing OHSS during a fresh COH-IVF cycle
2. Investigate the serum and follicular fluid levels for potential biomarkers of OHSS.

Eligibility Criteria:
Inclusion Criteria:

* Patients with more than 20 oocytes collected after COH in both gonadotropin-releasing hormone (GnRH) agonist and antagonist cycles

Exclusion Criteria:

* Patients with allergy to dopamine agonists
* Patients who undergo in-vitro maturation cycles
* Patients where GnRH analogues have been used to trigger oocyte maturation in antagonist cycles
Nasolacrimal Duct Obstruction

1.1 Background Obstructions of the lacrimal drainage system can be differentiated based on anatomical location or severity. But also, differentiating between congenital and acquired nasolacrimal duct obstruction (NLDO) is possible. The incidence of congenital NLDO (CNLOD) has been shown to be approximately 20%. Most of the cases undergo spontaneous remission, as the ductus nasolacrimalis may open spontaneously. About 2-12% display a symptomatic course. 2. S: 290; 3; 4, 5 Acquired NLDO may occur during childhood and adulthood. The incidence of symptomatic acquired NLDO is around 30 cases per 100.000 people in an US-based cohort study. S: 293; 30 Two major anatomical closure sites have been described, which are on the one hand located at the between the punctum and canaliculus, and on the other hand located after the lacrimal sac. 1. S. ; 2. S: 293 1.2 Aim of this study The aim of this study is to assess the success rates for different types of primary tear duct surgery, performed from 2013 - 2017 at the department of Ophthalmology and Optometry, Medical University of Vienna.

Treatment success was defined as the absence of clinical signs of lacrimal drainage system obstruction (epiphora, increased tear leak, mucous discharge) and without the need for re-intervention.

It is further investigated whether the type of operation performed or whether the silicone tube used influence success rates.

1.3 Methods A retrospective chart analysis of all patients - independent of the underlying pathology - undergoing surgery of the lacrimal drainage system between 1st of January 2013 and 31st December 2017. Success rates and patient profiles will be analyzed not only for all patients, but also for subgroups based on the underlying pathology and operation performed.


Eligibility Criteria:
Inclusion criteria

* All charts of patients treated during the above-indicated period of time will be considered for this analysis.

Exclusion criteria

* incomplete medical records are considered an exclusion criterion.
Changes of Microbiota in Irritable Bowel Syndrome Patients

To investigate the changes of gastrointestinal microbiota in irritable bowel syndrome patients by hydrogen breath test and molecular-based analysis of microbiota in gastrointestinal tract


Eligibility Criteria:
Inclusion Criteria:

* Case group: 20 to 80 years old irritable bowel syndrome patients
* Control group: 20 to 80 years old healthy subjects

Exclusion Criteria:

* without writtent informed consent
* contraindications for enteroscopy
Double Blind Randomized Trial to Compare Gurmar (Gymnema Sylvestre) With Metformin in Type 2 Diabetes

The study plans to compare the glucose-lowering effect of gurmar, a herbal preparation, with metformin in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Newly detected type 2 diabetes
* Fasting plasma glucose \>126mg/dl
* HbA1c \> 7%

Exclusion Criteria:

* Serious comorbid illnesss
* History of drug abuse
* History of recent weight loss
Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block

This is a prospective, randomized, single blinded trial involving human subjects. The goal of this study is to determine an optimal location (proximal or distal) for the nerve block and whether it will make a difference in how much opioid the patient will receive during and after surgery. Ultrasound will identify the adductor canal and the proximal end of the adductor canal/apex of the femoral triangle to determine the location of the blocks.

Their will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB proximal to true AC with bupivacaine 0.5% 20cc


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral, ACL surgery with allograft.
* Patients who consent to be randomized.
* Patients must be English proficient.

Exclusion Criteria:

* Patients younger than 18 or older than 75 years of age;
* Patients with a history of chronic pain or who are taking medications intended to treat chronic pain such as strong opioids;
* Patients with history of neurologic disorder that can interfere with pain sensation;
* Patients with a history of drug or alcohol abuse;
* Patients who are unable to understand or follow instructions;
* Patients with an allergy or a contraindication to any of the medications used in the study, or patients with a contraindication to any of the study procedures;
* Patients with severe liver disease, renal insufficiency, congestive heart failure, and/ or significant heart disease;
* Patients with a BMI over 42;
* Any patient that the investigators feel cannot comply with all study related procedures.
* Patients who do not tolerate Percocet.
Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer

This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been combined with other drugs but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced or metastatic breast cancer not amenable to local treatment.
* Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy.
* Patients must have at least one measurable lesion in an area not previously irradiated.
* No chemotherapy at least 4 weeks prior to study enrollment.
* Signed informed consent from patient.

Exclusion Criteria:

* Treatment with any drug within the last 30 days that has not received regulatory approval.
* Serious systemic disorders, including active infection.
* Significant cardiovascular disease.
* Pregnancy or breast feeding.
* Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)

This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing unilateral open inguinal herniorrhaphy.


Eligibility Criteria:
Inclusion Criteria:

* Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia.
* Has an American Society of Anesthesiologists Physical Status of I, II, or III.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

* Had any prior inguinal hernia repair.
* Has a planned concurrent surgical procedure.
* Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
* Has taken NSAIDs within 10 days prior to the scheduled surgery.
* Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).
* Has been administered bupivacaine within 5 days prior to the scheduled surgery.
* Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
* Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
* Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C.
* Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments.
* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention deficit/hyperactivity disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
* Has undergone 3 or more surgeries within 12 months.
* Has a body mass index (BMI) \>39 kg/m2.
Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women

OBJECTIVES: I. Determine whether physiologic testosterone replacement can increase fat-free mass, therefore contributing to weight maintenance, improved muscle function, and quality of life in HIV-infected women.

II. Examine the mechanism of testosterone-induced increase in fat-free mass.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of three arms.

Arm I: Patients receive two placebo transdermal patches applied twice a week (every 3-4 days).

Arm II: Patients receive one testosterone transdermal patch and one placebo transdermal patch applied twice a week (every 3-4 days).

Arm III: Patients receive two testosterone transdermal patches applied twice a week (every 3-4 days).

Patients receive 12 weeks of treatment in the absence of adverse reaction or health deterioration. Patients are followed on day 1, every 2 weeks during treatment, and at the end of the recovery period. Quality of life is assessed before treatment begins and at weeks 6 and 12.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Histologically confirmed premenopausal HIV-positive women who have experienced 5-15% weight loss

--Prior/Concurrent Therapy--

* Endocrine therapy: At least 3 months since megestrol At least 3 months since anabolic or androgenic steroids At least 3 months since oral contraceptives At least 3 months since Depo-Provera No concurrent hormone replacement therapy
* Other: Concurrent retroviral or protease inhibitors allowed, dosage must be stable At least 3 months since ketoconazole At least 6 weeks since the initiation of protease inhibitors

--Patient Characteristics--

* Hepatic: No significant liver disease SGOT/SGPT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Bilirubin no greater than 2 mg/dL No medical complications due to alcohol abuse
* Renal: Not specified
* Cardiovascular: No significant cardiovascular disease No uncontrolled hypertension
* Other: Testosterone level (early morning) less than 30 ng/dL Normal gastrointestinal function as indicated by: Absence of diarrhea Normal D-xylose absorption test No acute opportunistic infections or infectious illness No malignant disease No history of breast cancer No history of endometrial cancer No fever of known or unknown origin No unremitting diarrhea defined as: At least 4 watery stools per day OR More than 4 watery stools recently OR Acute change in stool habit with fever No significant respiratory disease No diabetes No illicit drugs within the past 6 months No history of hyperandrogenic disorders such as: Hirsutism Polycystic ovary disease Not pregnant or lactating
Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer

The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-PSMA-33 in patient with Prostate Cancer (PCa).

This study is design to prospectively investigate the safety and efficacy of 68Ga-PSMA-33 in the early diagnosis of Prostate Cancer (PCa). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-PSMA-33 in patient with PCa. While PSMA is expressed at low levels in normal prostate epithelium, it is overexpressed (up to 1000 times higher) in 90-95% of prostate cancers, make PSMA an attractive target for the diagnosis and treatment of PCa. 68Ga-PSMA-33 as a new PSMA targeted probe was prepared and showed good uptake on PCa cell line and animal studies.

The study intends to recruit 8 PCa volunteers to participate in the experiment. All patients were intravenously injected with 68Ga-PSMA-33 and underwent PET/CT at 0.5, 1, 2 and 4 h, respectively. For comparison, 3 patients were additionally received 68Ga-PSMA-617 PET/CT imaging. The images were interpreted by two experienced physician and the SUVmax or SUVmean of physiological organs and tumor lesions were collected.

Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 18 years or older
* Patients must have histologically or cytologically confirmed localized or metastatic prostate cancer
* Creatinine less than or equal to 1.5 X upper limit of normal
* ECOG performance status 0 - 2, inclusive
* Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation Patient with complete clinical data.
* The effects of 68Ga-PSMA-33 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, 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.
* Able to understand and provide written informed consent

Exclusion Criteria:

* Patient age \< 18 years
* Received radioisotope diagnosis or treatment before enrollment, and the time window did not exceed 10 physical half-lives
* Malignancy other than current disease under study
* Patient simultaneously participating in another clinical trial
* Patient who cannot stay on PET/CT
* Patient with HIV, HCV, HVB infection or other serious chronic infection
* Patient with liver and kidney function (GFR less than 50 ml/min) disease
* Cannot receive furosemide, allergy to sulfa or sulfa-containing medications
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine

This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.

. This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.

* The immunization schedule is two doses intramuscular injections (deltoid) with a 14-28 days interval.
* There will be 900 participants (300 health care professionals between 18 and 59 years old); 300 participants 75 years old or more; 300 participants between 60 and 74 years old. All participants must be allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Brazilian Immunization National Plan.
* For safety analysis , the incidence of adverse events after receiving the Adsorbed COVID-19 (inactivated) Vaccine that needed health assistance until 42 days after two-doses immunization schedule.
* The total period of participation in the study will be approximately 60 days after completing the two-dose schedule of the vaccine.
* Active pharmacovigilance studies are essential to assess the safety profile of the vaccine in subgroups that will be included as target populations in the Immunization Program.

Eligibility Criteria:
Inclusion Criteria:

* Adult allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Immunization National Plan.
* Informed consent form signed by participant.
* Show voluntary intention to participate in the study and availability throughout the study.

Exclusion Criteria:

* History of severe allergic reactions or anaphylaxis to previous vaccines or allergy to any components of the study vaccine.
* History of fever (axillar temperature ≥ 37,8º C) 72 hours before the vaccine
* Be unavailable during the study period.
* Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.
Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure

The purpose of this research study is to determine whether atenolol or controlled release carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure measured in the aorta, a large blood vessel carrying blood away from the heart, may be a better measure of the harmful effects of high blood pressure on the body's organs. In the past, blood pressure has only been measured in the arms. However, blood pressure in the arms may not accurately reflect the blood pressure in the aorta and thus may mislead doctors treating high blood pressure. For this reason, we are testing whether two different medications for blood pressure, both in a class called beta blockers, have similar effects on blood pressure in the arm and aorta.

Carvedilol reduces aortic wave reflection and improves left ventricular/vascular coupling: a comparison with atenolol (CENTRAL Study) is a prospective, open-label, comparative, randomized control trial that evaluated brachial and central hemodynamic profiles in patients taking atenolol or controlled-release carvedilol.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Hypertension (untreated or treated with no more then one anti-hypertensive drug)

Exclusion Criteria:

* Secondary forms of hypertension (including sleep apnea)
* Patients currently treated with two or more antihypertensive drugs
* Patients taking antihypertensive drugs with properly measured clinic systolic blood pressure greater then 170mmHg
* Isolated systolic hypertension
* Other diseases requiring treatment with blood pressure lowering medications
* Heart rate less then 55 beats/min (in the absence of beta-blocker therapy)
* Known cardiovascular disease including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and TIA)
* Known diabetes mellitus (Type 1 or 2)
* Renal insufficiency defined as a serum creatinine greater then 1.5mg/dL in males and 1.4mg/dL in females
* Primary renal disease
* Pregnancy or lactation
* History of Raynaud's syndrome
* Alcoholism and recreational drug use (due to compliance concerns)
Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD

A non-interventional study to assess the clinical effectiveness of Salmeterol/fluticasone Easyhaler to achieve and maintain asthma or COPD control.

A prospective, open-label, non-interventional, multicentre study in adult patients with asthma or COPD who are treated with Salmeterol/fluticasone Easyhaler. During the study the Salmeterol/fluticasone Easyhaler will be used according to the Summary of Product Characteristics. Clinical effectiveness of the treatment will be evaluated with change in asthma or COPD symptoms during 12 weeks treatment.

Eligibility Criteria:
Main Inclusion Criteria:

1. Male or female patients with asthma or COPD who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the study
2. Age ≥18 years.
3. Written informed consent obtained.

Main Exclusion Criteria:

1. Pregnant or lactating female patients.
2. Participation in other clinical studies during the study.
3. Known hypersensitivity (allergy) to salmeterol, fluticasone propionate or the excipient lactose
4. Any significant medical disease or condition or other factor that might interfere with study assessments or study participation.