cyrilzakka/clinical-trials huggingface dataset:
Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee

The purpose of this study is to determine whether a home-based exercise and weight control program applied to elderly overweight individuals with painful osteoarthritis of the knee, would result in pain reduction.

Osteoarthritis (OA) is the most common chronic disease in the United States (U.S.). Arthritis is a leading chronic illness among older adults in the U.S. Approximately 40% of individuals above 60 yr of age have OA of the knee. The primary objective of the proposed study is to determine whether individuals who are overweight with OA of the knee and who complete a 24-week home-based exercise program combined with a weight control intervention program will report significantly less pain (as measured by the WOMAC) than volunteers who participate in home-based exercise (Ex) only, weight control intervention (WC) only, or standard clinical care (C). The secondary objectives of the proposed research are to determine whether overweight individuals with OA of the knee who complete the Ex+WC program, when compared to subjects who are randomly assigned to a E, WC or C groups, demonstrate significant improvement in the following health risk profile variables: (a) improved physical function (measured by the Functional Performance Inventory), (b) improved capacity to perform stair climbing and descending, (c) improved strength, (d) increased lean body mass, (e) increase in physical activity at home (measured by pedometer step count). The proposed clinical trial will utilize a prospective, randomized two by two factorial design. Descriptive and ancova statistical method will be applied for data analyses.

Eligibility Criteria:
Inclusion Criteria:

* Male \& female 50 years old
* Diagnosis of osteoarthritis by American College of Rheumatology criteria
* Knee radiographs of Kellgren and Lawrence grade 2-4
* American Arthritis Association functional class 1-3
* Body mass index of 27

Exclusion Criteria:

* Knee arthritis which did not meet American College of Rheumatology (ACR) OA criteria
* Unable to engage in exercise or follow instruction
* Limited shoulder range of motion
New Magnesium Sulphate Protocol for Pre-eclampsia

there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol

The aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia.

The study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:-

* Systolic blood pressure ≥ 160.
* Diastolic blood pressure ≥ 110.
* Proteinuria \> +2 by dip stick.
* Presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding).
* Fetal growth restriction (IUGR).

After obtaining an informed consent the patients will be subjected to the following:

* Careful history taking including age, parity, gestational age.
* Complete physical examination and assessment of the blood pressure.
* Urine analysis by dipstick.
* All women will take initial MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes by IV drip) .

Using Random Number Table, the sample size will be divided into three categories:-

* Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.
* Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.
* Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate.

Inclusion criteria:

* Pregnant females ≥20 weeks of gestation.
* Pregnant females with criteria of severe pre-eclampsia.
* Single or multi-fetal pregnancy.
* Primigravida or Multigravida.

Exclusion criteria:

* Pregnant females \< 20 weeks gestation.
* Pregnant females with history of epilepsy.
* Pregnant females with diabetes.
* Pregnant females with chronic hypertension.
* Pregnant females with renal disease.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females ≥20 weeks of gestation.
* Pregnant females with criteria of severe pre-eclampsia.
* Single or multi-fetal pregnancy.
* Primigravida or Multigravida.

Exclusion Criteria:

* Pregnant females \< 20 weeks gestation.
* Pregnant females with history of epilepsy.
* Pregnant females with diabetes.
* Pregnant females with chronic hypertension.
* Pregnant females with renal disease.
Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to exemestane or any comparable or similar product.
Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia

Prior studies showed contradictory results about the best type of TENS in chronic pain pathology.

Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low back pain or chronic lumbo-radiculalgia.

The functional ability score is evaluated by the Roland scale at 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Stable chronic low back pain or stable chronic lumbo-radiculalgia
* Patients with a pain score at least superior or equal to 4
* Patients followed in pain clinics
* Written informed consent

Exclusion Criteria:

* Prior ambulatory TENS practice
* Lumbo-radiculalgia pathology surgery within 3 months before inclusion
* Acute low back pain or bilateral lumbo-radiculalgia
* Acute radiculalgia
* Surgery planned within 6 months
* Pacemaker
* Symptomatic low back pain
The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication

The investigators aim to compare the effect of changing their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure versus no intervention in the incidence of postoperative wound infections in pregnant women undergoing Caesarean section. The primary outcome is the incidence of any post cesarean wound related complication, including wound seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery, while the secondary outcomes are Postoperative fever: defined as greater than 38 degrees Celsius or post cesarean endometritis: defined as a clinical diagnosis, usually involving fever, uterine fundal tenderness, or purulent lochia requiring antibiotic therapy or Combined wound complications and endometritis.

The investigators conduct a prospective randomized study at Department of Obstetrics and Gynecology, AFHSR since April 2019 till October 2019, after approval of the study protocol by the Local Ethical Committee.

Patients undergoing Both elective and emergency cesarean sections and Patients received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case. All patients received appropriate pre-operative antibiotics, chlorohexidine skin prep except where allergies prohibited, and hair clipping as indicated.

The patients (600) are divided into two groups, Group A (300) during CS the surgical team change their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure, while in Group B (300) no intervention

Eligibility Criteria:
Inclusion Criteria:

1. Both elective and emergency cesarean sections.
2. Patient received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case.

Exclusion Criteria:

1. Women with active infection during the procedure.
2. Women did not receive the standard preoperative antibiotic prophylaxis.
3. Women with diagnosis of chorioamnionitis.
Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)

This is a single-center, randomized, blinded, controlled trial assessing the effects on the skin microbiome in patients with eczema of amending a standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO)


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female subjects aged who have a recent eczema itch flareup and/or pre-flare-up symptoms at screening as determined by visual analog scale (VAS).
* Diagnosis of mild to moderate eczema (grade 3 - 7 on the Rajka-Langeland severity index).
* Having a target lesion with an ADSI score of 6-12 and an erythema and pruritus subscore of ³2 (moderate).
* Generally good health based on reported history.
* Able to discontinue all medical and over the counter topical emollients, moisturizers, and / or other skin barrier lotions.
* Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug.
* Ability to administer topical medication and be willing to adhere to the study interventions.
* Agreement to adhere to Lifestyle Considerations throughout the duration of the study.

Exclusion Criteria:

* Pregnancy or lactation.
* Any type of malignancy involving the Study Site Area (Lesion or Non-Lesion site) in the last 5 years.
* Known allergy to hydrocortisone or topical antibiotic.
* Topical or oral use of an antibiotic within the last 7 days prior to baseline clinical visit.
* Bleach bathing in the 7 days prior to Baseline clinical visit.
* Current use of Class I-III topical corticosteroids or systemic medications (e.g. Dupixent) potentially affecting eczema or the skin.
* Surgeries or invasive medical procedures planned during course of study.
* Suspected non-compliance or non-cooperation.
* Intake of experimental drugs or experimental topical skin treatments within 30 days prior to study start.
* Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study.
* Diagnosis of human immunodeficiency virus in medical history.
A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Spontaneous Urticaria

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Spontaneous Urticaria.

There is a screening period of up to 4 weeks, followed by a 16-week placebo-controlled treatment period (Placebo-Controlled Treatment Phase) where patients will receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo, and then a 36-week treatment period where all patients will receive barzolvolimab. Patients who receive barzolvolimab 75mg or placebo in the placebo-controlled treatment phase will be re-randomized to receive either barzolvolimab 150mg or 300mg in the active treatment phase.

Eligibility Criteria:
Key inclusion criteria:

1. Males and females, \>/= 18 years of age.
2. Diagnosis of chronic spontaneous urticaria (CSU) \>/= 6 months.
3. Diagnosis of CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:

   1. The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
   2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
   3. UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to treatment.
4. Normal blood counts and liver function tests
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
6. Willing and able to complete a daily symptom electronic diary and comply with study visits.

Key exclusion criteria:

1. Women who are pregnant or nursing.
2. Clearly defined cause for chronic urticaria.
3. Active, pruritic skin condition in addition to CSU.
4. Medical condition that would cause additional risk or interfere with study procedures.
5. Known active HIV, hepatitis B or hepatitis C infection.
6. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
7. History of anaphylaxis
8. Prior treatment with barzolvolimab

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia

After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for prevention of agiation of preschool aged children. The investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.

There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

Eligibility Criteria:
Inclusion Criteria:

* Physical status classification of American Society of Anesthesiologist 1-2,
* Healthy, normal
* 2-6 years old
* Elective operation

Exclusion Criteria:

* Lack of consent
* Known adverse effects to dexmedetomidine, mental retardation
* Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc)
* No cardiac disease
Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery

The primary aim of our prospective, randomized, double-blind interventional clinical trial is to determine the effectiveness of high dose atorvastatin therapy to reduce post operative cognitive dysfunction (POCD) in patients undergoing cardiac valve surgery. We hypothesize that therapy with high dose atorvastatin will significantly reduce the incidence and/or severity of POCD.


Eligibility Criteria:
Inclusion Criteria:

* Fifty informed and consenting patients for cardiac valve surgery with CPB , greater than 50 years of age and under the care of one or more of the investigators or consultants will be prospectively enrolled over a one-year period (plus one-year for follow-up).

Exclusion Criteria:

* Patients with a history of the following disease entities will be excluded:

  * symptomatic cerebrovascular disease with substantial residual deficit, alcohol abuse, psychiatric illness, renal failure (creatinine\>2.0),
  * hepatic dysfunction (ALT or AST \> 1.5 x ULN), history of allergy or myopathy with statin therapy, pregnant or breastfeeding women or other comorbidities that in the opinion of the investigator could limit patient participation. Exclusion criteria are designed to limit confounding and enhance differentiation of deficits related to surgery and or treatment.
  * Patients who are unable to read and thus unable to complete the neurocognitive testing will also be excluded.
  * Patients having concomitant carotid endarterectomy or other vascular surgery will also be excluded to provide a more homogeneous sample for comparison.
Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units

Twenty-seven hospitals in China will participate in the study, which aims to increase breastfeeding rate in the neonatal intensive care unit (NICU) and reduce the clinical complications in very low birth weight infants and extremely low birth weight infants.

Breast milk reduces the risk of serious prematurity related morbidities. Quality improvement is an effective means of increasing breast milk feeding.Twenty-seven hospitals in China will participate in the study, which aims to increase breastfeeding rate in the NICU and reduce the clinical complications in very low birth weight infants and extremely low birth weight infants. This study compared the clinical data of very low birth weight infants and extremely low birth weight infants in three phases：Before-intervention phase，Intervention phase and Sustainability phase. During the Intervention phase and Sustainability phase multiple intervention bundles of quality improvement were implemented.The investigators will compare breast milk feeding rate and neonatal outcomes in different phases.

Eligibility Criteria:
Inclusion Criteria:

* premature Infants (Birth weight\<1500g)

Exclusion Criteria:

* mother with sever illness or communicable disease
BBTI vs PSR in Musculoskeletal Orofacial Pain Adults

This clinical study aims to compare the efficacy of two brief psychological interventions: Brief Behavioral Therapy for Insomnia (BBIT) and Physical Self-Regulation or (PSR) delivered over telehealth for the management of chronic musculoskeletal orofacial pain conditions (local myalgia, myofascial pain, centrally mediated myalgia) in a tertiary orofacial pain clinic. It is hypothesized that both interventions will produce beneficial changes and exploratory analysis will aim to establish which intervention -if any- is better for each specific outcome.

New patients who come into the orofacial pain clinic are evaluated by a dental resident and given an orofacial pain diagnosis. If this primary diagnosis involves masticatory myofascial pain, local myalgia, or centrally-mediated myalgia, and if patients self-report poor sleep, they will be introduced to the study. An initial evaluation for PSR and BBTI will be scheduled over telehealth. If willing and eligible to participate, at the end of this first evaluation, they will be provided with an informed consent form and be randomly assigned to three sessions of PSR or three sessions of BBTI. After providing an e-consent, they will be sent a questionnaire battery on REDCap to assess their outcomes at pre-intervention. A REDCap daily questionnaire will be sent every day (morning and evening) starting one week before session 1 of the intervention, until two weeks after the last session. Moreover, to a small group of patients randomly selected, an actigraphy watch will be mailed. Two weeks after the last session of the intervention, a REDCap questionnaire will be sent to assess their outcomes at post-intervention. As per the current clinical protocol, all participants will be offered both interventions; only data from the first intervention will be utilized for the current study. All PSR and BBTI sessions will be conducted via telehealth using a HIPAA-compliant zoom account.

Eligibility Criteria:
Inclusion Criteria:

* present with a score on Insomnia Severity Index \> 15
* have a primary diagnosis of chronic (onset more than 3 months before) MSK pain (myofascial pain and/or local myalgia and/or centrally mediated myalgia) from a board-certified orofacial pain specialist at UK Orofacial Pain Clinic
* maintain a stable medication regime in previous month and during the intervention
* older than 18 years old
* able to understand English
* willing to participate to telehealth intervention
* have internet access and an email address
* present with total STOP BANG score \< 5

Exclusion Criteria:

* less than 18 years old
* unable to provide informed consent
Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence

The purpose of this study is to investigate the safety and the prognosis after achieving reduced alcohol intake in patients with alcohol dependence who received treatment for the reduction of alcohol intake in the routine clinical setting in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alcohol Dependence
* Must agree to follow-up during the first year of prescription and publication of survey results
* Patients whose goal of treatment for Alcohol Dependence is to reduce alcohol consumption
* Patients receiving psychosocial treatment aiming to promote treatment adherence and reduction of alcohol consumption
* Patients who have chronic heavy drinking
* Patients who have confirmed that they are willing to receive treatment to reduce their alcohol consumption

Exclusion Criteria:

* Patients who has ever been treated with nalmefene hydrochloride hydrate
* Patients who are contraindicated
Novel Approach With Double Agent Artificial Oocyte Activation for Repeated Fertilization Failure Due to Combined Sperm and Oocyte Factor

Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection.

In some cases undergoes assisted reproduction technique specially Intracytoplasmic sperm injection, in subgroup of patient they fail to fertilize or poorly fertilized, some authors recommend chemical activation for those group of patient with Ca ionophore but still with Ca ionophore there are some cases with total fertilization failure or low fertilization specially in those patient with 2 separate factors like teratozoospermia with poor quality Oocytes so the investigators decided to test the effect of double activation methods by using tow agents proven with life birth rate Ca ionophore and strontium chloride.

We Do intracytoplasmic sperm injection and immediately activate oocyte with Ca Ionophore followed by strontium chloride activation and monitoring the embryogenesis until the blastocyst formation and pregnancy outcome in multicenter assessment.

Eligibility Criteria:
Inclusion Criteria:

* poor sperm
* poor quality Oocytes
* previous failed fertilization
* previous poor embryogenesis

Exclusion Criteria:

* normal patient
* previous successful outcome