cyrilzakka/clinical-trials huggingface dataset:
Blood Pressure Lowering in Dialysis (BOLD) Trial

Blood pressure may be one of the most important modifiable risk factors for cardiovascular disease in patients with end-stage-renal-disease undergoing maintenance hemodialysis. Although a systolic blood pressure \<140 mmHg treatment target has been recommended, there remains uncertainty on which blood pressure should be targeted, more specifically that measured in the dialysis unit or at home. Observational studies have reported a paradoxical U-shaped associated with dialysis unit (pre-dialysis) systolic blood pressure and cardiovascular events and death (where blood pressure below 140 mmHg is actually linked with poor outcomes). Conversely, the same studies have reported a linear association between higher home systolic blood pressure and worse clinical outcomes, where blood pressure below 140 mmHg is associated with better outcomes. This pilot clinical trial aims to address this important question.

Blood Pressure Lowering in Dialysis (BOLD) is a pilot randomized controlled trial of 50 maintenance hemodialysis patients in San Francisco and Seattle to test whether targeting a home systolic blood pressure \<140 mmHg (versus a pre-dialysis systolic blood pressure \<140 mmHg) is feasible and safe. The study duration is 4 months and blood pressure targets will be achieved through dry weight adjustment and adjustment of standard anti-hypertensive therapies by the study team. The primary outcomes are focused on feasibility and safety. The home blood pressure treatment arm will also have the opportunity to utilize a blood pressure monitor with Bluetooth capabilities. The rates of utilization of mobile health technology in this population will also be assessed as an outcome. This pilot trial will provide key data to design a larger trial focused on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Undergoing in-center, thrice weekly hemodialysis for treatment of end-stage-renal-disease
3. Greater than 3 months since initiation of dialysis
4. Age 18 years or above
5. Able to obtain a brachial blood pressure at dialysis and at home

Exclusion Criteria:

1. Pregnancy, anticipated pregnancy, or breastfeeding as this will require increase to more than three time a week dialysis and/or preclude use of some classes of blood pressure medications
2. Incarceration or institutionalized living which may prohibit measurement of home blood pressure
3. Participation in another intervention study that may affect blood pressure
4. Patients in whom systolic blood pressure is not measurable (e.g. those with left ventricular assist devices)
5. Hypotension: average pre-dialysis systolic blood pressure \<100 mmHg over last 2 weeks prior to screening while not taking any blood pressure medications
6. Life expectancy \<4 months
7. Anticipated living donor kidney transplant within 4 months
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis

This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic plaque psoriasis
* 10 - 35% BSA of involved skin
* Age 12 - 17

Exclusion Criteria:

* Other type of psoriasis (other than plaque)
* Significant abnormal lab findings
* Vit D insufficiency
Dosing of Ketorolac Impacts Post-cesarean paiN manaGemenet (KING)

This is a randomized controlled single blinded trial to compare the morphine milligram equivalents (MME) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.

Administration of a dose of ketorolac for postoperative pain management at end of cesarean is routine practice at our institution.

This is a randomized controlled single blinded trial at The Ohio State University comparing a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room immediately after cesarean section.

Potential study participants will be identified at the time of admission to Labor and Delivery unit. Inclusion criteria must be met, namely patient's age, mode of delivery via cesarean section. The decision for mode of delivery will be at the discretion of the primary obstetrics (OB) provider. Indications for cesarean delivery would be: scheduled cesarean due to history of previous uterine surgery including prior cesarean section, failed induction of labor, arrest of second stage of labor, non-reassuring fetal status.

Patients will be approached for consent and enrollment when decision is made to proceed for cesarean section by their primary provider. Patients with allergy to Non-steroidal anti-inflammatory drugs (NSAIDs), history of opioid use disorder, chronic pain disorders, or undergoing an emergent Cesarean section, will be excluded from the study.

Once the decision has been made by the primary obstetrics (OB) provider to proceed with cesarean delivery, participants will be randomized in to one of two groups:

* Single dose of IV Ketorolac 30mg Vs.
* Single dose of IV Ketorolac 60mg

The intervention and primary outcome will take place over the span of 24 hour post-cesarean. Once enrolled and randomized, patients will be given either 60 mg or 30 mg of IV ketorolac at the end of the procedure. All other obstetric care will be at the discretion of the primary provider, including but not limited to pain management postoperatively. Analysis will be by intent to treat. The secondary outcomes will be collected during the hospital stay until discharge.

Eligibility Criteria:
1. Inclusion criteria:

   * Pregnant individuals aged 18-45 with a viable single or twin intrauterine pregnancy
   * Cesarean section as the delivery mode
   * Regional anesthesia (Spinal, Epidural, Combined Spinal Epidural)
2. Exclusion criteria:

   * Known allergy or adverse reaction to Non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or ketorolac
   * Patients with peptic ulcer disease, preexisting kidney or liver disease
   * Hemodynamically unstable due to hemorrhage
   * Acute or chronic pain disorder
   * Physician/provider or patient refusal
   * Estimated blood loss \> 2000 mL
   * General anesthesia
   * Opioid use disorder
   * Emergent Cesarean delivery
   * Coagulation disorders
   * Active asthma
   * Patients weighing \<50 kg
Antenatal Palliative Care

In France, according to current legislation, termination of pregnancy could be performed without any upper gestational age limit, if there is a strong probability that the fetus will be affected by a particularly severe and incurable disease. When there is a lethal fetal diagnosis most of parents wish to terminate their pregnancy. However, and despite some medical resistance a few of them do wish to continue pregnancy. In these situations, palliative care seems to be a good way to prepare to welcome the child and surround him until death.

The aim of the study is to describe parents' experience for a better understanding and a better care.


Eligibility Criteria:
Inclusion Criteria:

* The woman must be between the ages of 18 and 50 and the adult,
* Participants must have received the information and not have objected to participating in the study,
* the lethal / adverse short-term prognosis of the fetal pathology must have been confirmed by a committee of experts (CPDPN),
* The choice to continue the pregnancy should have been clearly expressed,
* The birth of the child should not be older than 24 months.
* The child's death must be more than 6 months old (or not have occurred)

Exclusion Criteria:

* Non-mastery of the French language,
* Measure of legal protection of one of the members of the couple (guardianship, trusteeship, ...),
* Severe psychiatric or neurological disorders inducing significant cognitive impairment.
Assessing Chronic Pain Conditions in Patients (Pts) With and Without (w&wo) Interstitial Cystitis

Interstitial cystitis (IC) is a chronic disorder with significant symptoms of urinary urgency, frequency and pelvic pain. IC is more prevalent in women than men. Similar to other chronic pain syndromes such such as irritable bowel syndrome (IBS) and fibromyalgia, the cause of IC is not fully understood. Two subtypes of IC have been identified: classic IC (ulcerative IC) where visible ulcers exist in the bladder and non ulcerative IC, where bladder abnormalities are not apparent but significant bladder-related symptoms exist. We hypothesize that ulcerative IC is a disease of the bladder whereas non ulcerative IC is a more generalized and centrally-mediated chronic pain syndrome similar to IBS and fibromyalgia. To test this hypothesis, we will compare the presence of pain conditions/symptoms in ulcerative vs. non ulcerative IC women vs. community dwelling women (controls) without an IC diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years of age with IC identified by investigator (cases);
* Women over 18 years of age with IC (controls)

Exclusion Criteria:

* Male gender;
* subjects less than 18 years of age
Respiration and The Airway With Supraglottic Airway Devices

The investigators aim to compare the airway seal pressure( oropharyngeal leak pressure) of the Self Pressurized Airway Device with Blocker® with the ProsealTM Laryngeal Mask Airway (P-LMA)in anesthetized paralyzed adult female patients undergoing elective gynecological operations. The investigators aim at assessment of fitting of both devices against the glottic region that detected by the flexible fiberoptic bronchoscope( Pentex Corporation, Medical Division, Singapore)and assessment of any associated postoperative complications.

Hypothesis:

The investigators hypothesize that the self-pressurized air-Q with blocker has a greater seal pressure compared to Proseal, easier and faster in insertion with less morbidity and complications during and after its insertion.

The study will be carried on adult female patients to reduce variability in size of the chosen device to enable the investigators to analyze the performance parameters of the two devices with greater authority. The study will be done on anesthetized paralyzed adult female patients undergoing elective gynecological operations that require neuromuscular block but not necessarily tracheal intubation. The investigators will recruit 150 adult female(18-55 years old, ASAI\&II) patients to a prospective randomized comparative controlled two-arm parallel clinical trial. Patients with history of upper respiratory tract infections, obstructive sleep apnea, potentially full stomach (trauma, morbid obesity BMI\> 35, pregnancy, history of gastric regurgitation and heart burn), those with esophageal reflux (hiatus hernia), and those of coagulation disorders will be excluded from the study. All patients will be assessed pre-operatively El-Ganzouri airway score to assess the expected difficulty of intubation and patients with airway scores ≥ 5 will be excluded from the study. The patients will be randomly allocated into two groups(the SP-Blocker group \& the P-LMA group; each group is 75 patients) using computer generated program . An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients ASA I\&II
* Age: 18- 55 years old
* BMI \< 35
* Undergoing elective gynecological operations.

Exclusion Criteria:

* Patients with history of upper respiratory tract infections and obstructive sleep apnea.
* Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia.
* Patients with coagulation disorders.
* Patients with El-Ganzouri airway score ≥ 5 will.
Role of Droperidol in Postoperative Vomiting

Protocol title: Role of low dose droperidol in postoperative vomiting

Purpose: Evaluate the efficacy of droperidol to postoperative nausea and vomiting when administrated at the introduction to anesthesia, prior to surgery

Design: Prospective, randomized, placebo-controlled study

Patient Population: Male or female subjects 18 years of age or older who are scheduled for laparoscopic cholecystectomy

No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll

Duration of Treatment: Prior operation

Duration of Follow-up: Follow-up will be performed for 24 hours postoperatively

Endpoints: To evaluate the effectiveness of low dose droperidol when administered Prior surgery

In this prospective, randomized, placebo-controlled study, the researchers determined whether 0.625 mg (1/2 amp) IV droperidol given at the initiation of general anesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in laparoscopic cholecystectomy population. One hundred patients receiving general anesthesia for laparoscopic cholecystectomy received droperidol 0.625 mg (1/2 amp) mg or placebo prior operation.

Eligibility Criteria:
Inclusion Criteria:

* Patient more than 18 years old
* Patients scheduled for laparoscopic cholecystectomy
* Informed consent obtained from the patient

Exclusion Criteria:

* Age \< 18 years old
* Contraindication to laparoscopic surgery
* Present a severe depressive syndrome
* Pregnancy women
* Trouble of cardiac rate
* Alcoholism
* Contra-indication for Droperidol prescription
Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening

Breast tumors are often detected on mammography but may be harder to see in women with dense breasts. This is why screening breast ultrasound is sometimes used as another test in women with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen on regular mammography.

Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is essentially a routine digital mammogram performed after iodine dye (the same that is used with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this study is to compare whether CEDM or screening breast ultrasound is better at detecting cancer. Both will be done in this study and compared to one another.


Eligibility Criteria:
Inclusion Criteria:

* Women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other
* Women scheduled for screening CEDM alone
* Women scheduled for WBUS and screening CEDM on the same day or within 30 days of one another

Exclusion Criteria:

* Age \< 30 years old
* Male patients
* Patients with any clinical breast symptoms (palpable mass, nipple discharge, etc)
* Patients with known diagnosis of breast cancer
* Patients with any breast surgery or biopsy within 90 days prior to the study
* Patients who have had a lumpectomy for breast cancer within 18 months prior to the study
* Patients who are thought to have a breast MRI within 1 year prior to the study
* Patients with contraindication to the intravenous use of iodinated contrast agent (i.e. allergy to iodinated contrast or severely impaired renal function with a creatinine level ≥1.3)
Determination of Normal Values for the Star Excursion Balance Test (SEBT) in Handball Players

the aim of this study is to determine normal values for SEBT in young national or international handball women players for determining specific level for SEBT to predict risk of injury


Eligibility Criteria:
Inclusion Criteria:

* women
* age from 14 to 18 years old
* national or international level for handball

Exclusion Criteria:

* no french language
* players who don't understand the instructions to perform the test
* Refusal to perform the test
Differentially Expressed Proteins in Sporadic Parathyroid Tumors

Primary hyperparathyroidism (PHPT) is one of the common endocrine disorders. The major clinical symptoms involve stones, bones, abdominal groans and psychiatric moans. Increased parathyroid cell proliferation and decreased calcium-mediated control of the PTH secretion are characteristic findings. The most common cause of PHPT is adenoma followed by hyperplasia and carcinoma.The molecular mechanisms involved in parathyroid tumorigenesis are partially known. Few genes have been identified and their roles are under study.

The genes which are under study by different groups are unable to give a definite direction towards the understanding of parathyroid tumorigenesis and the mechanism involved in overgrowth of parathyroid tissue. So identifying different proteins and their regulation pattern from adenomas to carcinomas will be the initial steps towards understanding the proteins involved in tumorigenesis of parathyroid tissues. By using proteomics approach one can generate protein level information. In this study, using a combined approach based on 2 D gel electrophoresis and mass spectrometry (MS), the investigators propose to study a comparative proteomics to examine the changes of protein profiles in parathyroid tumor tissues with normal and hyperplasic parathyroid tissues. This work plan will help us to understand differentially expressed proteins in patients with PHPT. This will help in understanding the disease and identifying better diagnostic and curative measures of the disease. The investigators are also planning to access nuclear morphometry changes in sporadic parathyroid tumors. It will help in establishing cellular and nuclear change pattern variations from normal to parathyroid tumors.

Subjects:

All the PHPT patients attending outdoor patient clinic of Endocrinology and General Surgery department of Nehru Hospital, PGIMER, Chandigarh will be enrolled in this study.

Sample collection:

A parathyroid tissue sample will be taken from the patients undergoing for parathyroidectomy. Samples will be collected immediately after surgery, snap frozen and stored at -80oC until use. In addition 10 ml of blood will also be taken from these patients for estimating biochemical parameters.

Controls:

Normal parathyroid gland will be used as control and it will be obtained from patient undergoing thyroidectomy for multinodular goiter as an elective procedure at the institute.

Eligibility Criteria:
Inclusion Criteria:

* PHPT patients with parathyroid adenoma, hyperplasia and carcinoma

Exclusion Criteria:

* Patients with family history, HPT-JT syndrome and familial isolated hyperparathyroidism
Intravitreal Bevacizumab vs Photocoagulation for Proliferative Diabetic Retinopathy

The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the treatment of patients with untreated symmetric proliferative diabetic retinopathy.

The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. However, it is a treatment that results in significant discomfort to the patient, causes reduction of visual acuity and visual field impairment. Intravitreal bevacizumab is a novel treatment that reduces intraocular VEGF concentration and therefore inhibits neovascular proliferation, without causing significant disconfort to the patient, nor affecting visual acuity or visual fields (although with other risks associated with intravitreal injection). Making a comparison between both treatments in different patients is difficult because there are other variables that influence the progression of the disease (such as glycemic control or renal insufficiency). Therefore this study is designed using both treatments in the same patient: intravitreal bevacizumab in one eye, compared to panretinal photocoagulation in the contralateral eye, and evaluating visual acuity, visual fields, fluorescein angiography, optic coherence tomography of the macula, and patient discomfort, in a one-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* symmetric proliferative diabetic retinopathy without high risk characteristics
* age 18 years or older
* patient consent

Exclusion Criteria:

* heart attack or cerebrovascular attack
* only eye
* retinal detachment
* vitreous haemorrhage
* previous treatment for diabetic retinopathy
* media opacities that preclude visualization of the fundus
* pregnancy
* inability to understands the implications of the protocol
A Study to Evaluate the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Patients With Mild to Moderate Hypertension

The purpose of this study is to determine the response rate for the therapeutic goal (diastolic blood pressure (BP) less than 90 mmHg and systolic BP less than 140 mmHg) at Week 6 for quinapril 20 mg and at Week 12 for quinapril 20 mg, quinapril 40 mg, and quinapril 20 mg plus hydrochlorothiazide 12.5 mg; and to determine the mean decrease in diastolic and systolic BP measurements and the change in heart rate at Week 6 and Week 12 compared with baseline.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of mild to moderate primary hypertension ("Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, 6th report" Stage I or II)
* Sitting diastolic blood pressure between 90 mmHg and 109 mmHg and systolic blood pressure between 140 mmHg and 179 mmHg at the end of the no-treatment run-in period

Exclusion Criteria:

* Subjects with secondary hypertension
* Subjects with serious cardiac disease (including myocardial infarction in the last 3 months or decompensated heart failure)
* Subjects who do not accept to stop using any other antihypertensive treatment during the run-in period and the treatment period of the study
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)

To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.

This is a phase 1, randomized, double-blind, placebo-controlled, single-and multiple ascending dose study. Up to eighty-eight subjects with Systemic Lupus Erythematosus will be selected to participate. Subjects will be randomized to receive either ABT-199 or placebo. Subjects will be administered ABT-199/placebo as a single dose or up to 14 days as multiple doses.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus for at least 6 months.
* Documentation of at least one of the following: ANA titer \>= 1:160 or positive anti-dsDNA antibodies.
* Stable systemic lupus erythematosus medication regimen.
* Other than systemic lupus erythematosus, subject should be in general good health.

Exclusion Criteria:

* Male.
* Drug-induced or highly active systemic lupus erythematosus.
* Significant autoimmune disease other than lupus.
* Significant, uncontrolled or unstable disease in any organ.