cyrilzakka/clinical-trials huggingface dataset:
Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program

In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors than women. They are less likely to be tested for HIV, initiate combination antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage in the care of their female sex partners, even though couple care-seeking is associated with marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program for providing immediate, lifelong combination antiretroviral therapy (cART) to all HIV-infected pregnant women at the time of diagnosis, is an important entry-point for involving male partners in care.

This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male partner involvement within the Option B+ program. In both arms (patient referral and contract referral) women will be encouraged to invite their male partners to accompany them to the clinic for couple HIV counseling and testing. In the contract referral arm, if the couple does not present within one week, the male partner will receive a home visit encouraging them to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men. Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's HIV program.

Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+ context. We will assess acceptability of eligible females to participate in this pilot RCT and reasons for non-participation.

Objective 2: Assess whether study arm (patient referral versus contract referral) is associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of male partner recruitment. This study will contain two arms: patient referral and contract referral for uptake of cHTC (primary outcome).


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or 16-17 years old and married

  * Pregnant
  * Received a positive HIV-test within the last day
  * Will be in Lilongwe for the next month
  * Able and willing to give locator information for \>1 male partner in the Bwaila District Hospital catchment area (either a mobile number, a physical address, or both)

Exclusion Criteria:

* Enrolled/enrolling in the PROMISE study
* Initially Presenting with a male sex partner
An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment

To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects.

In Part One, 8 subjects with moderate hepatic impairment (Child Pugh Scale B) and 8 matched healthy subjects will be enrolled. In Part 2, 8 subjects with mild hepatic impairment (Child-Pugh Scale A) and 8 matched healthy subjects will be enrolled. In Part 3, 3 subjects with severe hepatic impairment (Child-Pugh Scale C) will be enrolled. Parts 2 and 3 will only be initiated if the criteria per protocol is met in Part One. The pharmacokinetics and safety profiles will be compared between hepatic impaired subjects and healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between 18 and 65 years of age
* Negative test for the selected drugs of abuse at screening

Hepatic impaired subjects:

* Stable hepatic function and medication regimen for at least 28 days prior to check-in
* Degree of hepatic impairment will be determined by the Child-Pugh Scale

Exclusion Criteria:

* Clinical manifestation of any disease (except hepatic impaired subjects)
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, including food, or other substance
Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two IOLs: Hoya iMics Y-60H vs. Bausch&Lomb MI60 (MIMI)

Age-related cataract is the main cause of impaired vision in the elderly population worldwide.

The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.

The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.

Modifications in IOL design and material lead to a decrease in the incidence of PCO.

During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.

The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 4 years.


Eligibility Criteria:
Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution

Exclusion Criteria:

* previous intraocular surgery or ocular trauma
* intraocular complication like posterior capsular tear
* glaucoma
* uveitis
* corneal diseases, diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
Virtual Agents-based Digital Interventions to Improve Health

KANOPEE is a free smartphone application providing screening, follow-up tools and autonomous digital interventions to lower psycho-social stress and its repercussions on sleep and behaviors in the general population.

Additionally, KANOPEE permits an adaptation of the intervention to the subject (i.e., an adapted waiting period, frequency, and content), enabling to perform innovative trial conditions.

The objective of this long-term study is to evaluate the efficacy of KANOPEE on users among the French general population exposed to psycho-social stress.

KANOPEE was designed by sleep specialists and psychiatrists to propose autonomous interventions to improve sleep, physical activity and substance abuse ; aiming at lowering psycho-social stress's repercussions. The app provides weekly interactions with a virtual companion.

At each interaction, users answer standardized questionnaires (e.g., Insomnia Severity Index, Cigarette Dependence Scale) enabling to characterize users' health status (i.e;, the severity of the complaints) and evolution over time, and therefore provide adapted interventions based on the literature (e.g., digital Cognitive Behavioral Therapies, diaries, sleep hygiene recommendations, motivational interviewing).

The app is freely available to the general population in France, enabling very large sample size, and the possibility to perform non-randomized trials depending on the selected interventions by the users and the subject's group.

Eligibility Criteria:
Inclusion Criteria:

* Being aged 18 years old and over (the app is available for younger users but their data will not be analyzed)
* having downloaded the app
* having a smartphone Android or Iphone
* being located in France
* having accepted the electronic informed consent

Exclusion Criteria:

* having clicked on the "emergency button" (in the app, there is a warning message : this app is not for emergency situations. If you need an urgent psychological support, click here")
* having downloaded the app but without answering any questionnaire
Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers

The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy subjects.

A single blind, randomised, 3-period, 3-sequence single-dose crossover study to determine the pharmacokinetic dose proportionality of Clonidine MBT 50 μg and Clonidine MBT 100 μg and comparative bioavailability of clonidine from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy male and female subjects.

36 subjects will be randomised for 30 to complete the study. The study will comprise of 3 Treatment Periods (1, 2 and 3) and a post study follow up (7 - 12 days after the last dose). Study drug will be administered on the morning of Day 1. Pharmacokinetic (PK) blood samples will be collected for each of three treatment periods. Safety will be evaluated at specified times throughout the study. There will be at least 7 days between dose administrations.

Eligibility Criteria:
Main Inclusion Criteria:

* Healthy males or females (non-pregnant/non-lactating) aged 18 - 50 years.
* A Body Mass Index (BMI) of 18-30.
* No clinically significant abnormal serum biochemistry, haematology and urine examination values.
* A negative urinary drugs of abuse screen.
* Negative HIV and Hepatitis B and C results.
* No clinically significant abnormalities in 12-lead electrocardiogram (ECG).
* No clinically significant abnormalities in blood pressure or pulse.
* No allergy or sensitivity to clonidine or any of its excipients.
* No allergy to milk or milk derivatives.
* Subjects must provide written informed consent to participate in the study

Main Exclusion Criteria:

* Current or past medical condition that might significantly affect the pharmacokinetic or
* pharmacodynamic response to clonidine.
* Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days.
* Pathological condition of the oral cavity that would affect administration via the buccal route.
* Raynaud's disease or other peripheral vascular disease.
* Receipt of regular medication within 14 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
* Symptomatic postural hypotension evident on screening
* History or evidence of Suicidal Ideation and/or behaviour as determined by using Columbia-Suicide Severity Rating Scale (C-SSRS)
Medication Use Evaluation (MUE) for Continuous Heparin Infusions in Hospitalized Patients

Unfractionated heparin (UFH) is an anticoagulant to prevent thrombus formation or worsening of an existing thrombus. It is indicated for patients with deep vein thrombosis/pulmonary embolism (DVT/PE) or acute coronary syndrome (ACS). Unfractionated heparin treatment consists of an initial bolus followed by a continuous infusion that is adjusted based on the patient's subsequent partial thromboplastin time (PTT) levels

Unfractionated heparin is classified as a high-alert medication in the acute care setting.3 Therapeutic anticoagulation is a high priority for healthcare teams because the impacts of inadequate anticoagulation can lead to life threatening events such as a major bleed or thrombus formation and/or death.

Eligibility Criteria:
Inclusion Criteria:

* Patient's aged 18 years or older with a confirmed diagnosis of DVT/PE based on imaging or a confirmed diagnosis of ACS requiring heparin therapy

Exclusion Criteria:

* History of bleeding in the last 30 days
* History of HIT
* Use of systemic anticoagulants for another indication
* Presence of coagulation disorder prior to admission (i.e. hemophilia, sickle cell anemia, etc.)
Apparatus and Method for Moving Patients

A novel device and process to move patients has been developed, particularly useful for patients with severe respiratory failure (ie COVID 19) who require prone ventilation (moving from their back onto the stomach and then onto back for a 16 hour cycle, usually for several days).

This study will assess staff impressions of the feasibility of the use of this device/ process to prone patients as well as their impressions of the use of this device, compared to repositioning sheets, for the general care of the ICU patient. An economic analysis of the use of the AMMP for proning compared to movement without assists will be done

Movement of non ambulatory patients is typically a physically demanding, resource intensive intervention that places the healthcare team members at risk of injury. A quantitative survey of healthcare team members perspectives on the challenges associated with patient movement will be distributed.

This is particularly true for caregivers responsible for severely ill respiratory failure patients (ie COVID 19) who are moved into prone position (flipped on to their stomach) and back to supine over a 16 hour cycle, typically repeated for several days, as part of their therapy. (proning) A method of wrapping the patient in a secure "cocoon" which is coupled to a mechanical lift system through a designed strapping system and support bar will be tested for proning on healthy volunteers and then in the clinical environment ( intensive care unit (ICU) . Healthcare team members will complete surveys to assess ease of use, efficiency, safety and physical demands of this process relative to traditional (control) manual methods of patient reorientation, without the use of assists for proning.

Critically ill nonambulatory patients require assistance to move. The AMMP can be used to assist and impressions of this device. Comparing the impressions of healthcare team members of the use of the AMMP, repositioning sheets, and to care without the use of a movement assistance device will be undertaken using quantitative surveys An economic analysis of the use of the AMMP to prone patients, focused on personnel time and personal protective equipment use, compared to proning without assistance, will be completed

Eligibility Criteria:
Inclusion Criteria:any adult ICU patient is eligible for enrolment in assessment of health care team members impressions of the use of repositioning sheets for general care ( movement up or down the bed or in to lateral position) Adult ICU patients admitted to the ICU with severe respiratory failure (PaO2/FiO2 ratio \<150) are candidates for use of the AMMP for prone positioning unless exclusion criteria are present Adult ICU patients requiring general care are candidates for use of the AMMP for general care unless exclusion criteria are present -

Exclusion Criteria:discretion of ICU attending, unable to obtain consent, unstable spine fracture, chest tube drainage in place, open abdomen, \>140 kg

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Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)

Following data have been recorded each three months: QoL (MOS-SF 36 and ALSAQ), bodily mass index, testing and ALS-FRS scale, functional respiratory measures, impedance analysis, and the time for tube feeding procedure, the conditions of the acceptance and side-effects of gastrotomy

Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 years-old
* ALS certain or probable
* vital capacity (respiratory) \> 70 %
* under riluzole

Exclusion Criteria:

* ALS in family
* other conditions affected survival and QoL
* cognitive impairment
Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease

The aim of the study is to analyze the effect of 12 weeks of arm crank exercise (ACE) training on cardiovascular function in PAD patients, and compare it with treadmill exercise (TE), the actual recommendation for this patients. In this clinical trial, 45 patients will be allocated randomly in three experimental groups: ACE training, TE and control group. ACE and TE groups will perform exercises twice a week with the intensity equivalent to 13- 15 on Borg's Subjective Perception Exertion Scale. Patients in control group will meet twice a week, however only to perform diverse activities and group living, without any type of exercise involved. All groups will be encouraged to increase their levels of activity, as they are usually guided in medical consultations. Before and after 12 weeks of intervention, cardiovascular function, functional capacity, cognition, and quality of life will be assessed.

Arm-crank exercise (ACT) is an alternative exercise strategy for patients with symptomatic peripheral artery disease (PAD) due the benefits on functional capacity and quality of life, besides provoking less or no pain symptoms during the execution. This study sought to describe the protocol of a study that will analyse the effect of ACT exercise on walking capacity, cardiovascular function, cognition and quality of life in patients with symptomatic PAD.

This is a three-armed randomized, prospective, single-blind data collection, single-center, controlled study enrolling 45 patients with symptomatic PAD which will be randomized into 3 intervention groups: walking training (WT), ACT (WT and AC: 15 to 10 sets of 2 to 5 minutes, Borg 13 to 15) and control group (CG). Before and after 12 weeks of intervention, cardiovascular function (ambulatory blood pressure , clinic blood pressure, central blood pressure, heart rate variability, arterial stiffness, vascular function), functional capacity (six-minute walking test, 2 minute step test \[2 MST\], Walking impairment questionnaire \[WIQ\], Walking estimated limitation calculated by history \[WELCH\], Baltimore activity scale for intermittent claudication, handgrip test and short physical performance battery \[SPPB\]), cognition (executive function and memory) and quality of life (short version of world health organization quality of life and vascular quality of life questionnaire \[VASCUQOL-6\]) will be assessed.

This is the first trial to evaluate the effects of ACT on regulatory mechanisms of cardiovascular system in PAD patients. If the results are as expected, they will provide evidence of ACT in promoting cardiovascular benefits in symptomatic PAD population.

Eligibility Criteria:
Inclusion Criteria:

* PAD stage II
* Ankle brachial index \<0.90 in one or both lower limbs;
* Women in post-menopause phase without hormone replacement therapy
* Not an active smoker;
* Able to perform exercise training;

Patients selected to participate in the study will be only excluded if:

* Change their medication;
* Present any health impairment that contraindicates the practice of physical exercise during the study;
Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients

This is a clinical study comparing the physiologic effects of two hypertonic solutions (mannitol, hypertonic saline) with a particular emphasis on changes in cerebral blood flow in patients with intracranial hypertension following serious traumatic brain injury (TBI).

This is a study comparing effects of two hypertonic solutions (mannitol, 6.4% hypertonic saline) on intracranial hypertension, cerebral blood flow, serum/urine osmolarity in patients with increased intracranial pressure caused by traumatic brain injury. The study is conducted during first 72 hours after the injury without any interference with standard medical treatment as performed at the institution. When the hypertonic solution is indicated by caregiver, the study team is informed and performs a set of physiologic bedside measurements including evaluation of cerebral blood flow and changes in plasma and urine osmolarity. The study is noninvasive and the study protocol does not hamper, in any way, standard care of treatment for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe TBI (motor Glasgow Coma Scale \[GCS\] score \< 5)
* Age \> 18 years
* Health care provider indicated a treatment of intracranial hypertension using hyperosmotic agent

Exclusion Criteria:

* Brain dead (GCS 3, fixed dilated pupils)
* Life-threatening systemic injuries (AIS \> 4 in an organ system other than brain); AIS = Abbreviated Injury Score
* Hypotension not responsive to fluid resuscitation and low doses of dopamine
* Clinical or imaging sign/suspicion for internal carotid artery injury
Motivational Incentives for Enhanced Drug Abuse Recovery: Methadone Clinics. - 1

The purpose of this study is to test the utilization of incentive values (considerably lower than those typically used in research clinics) to motivate clients to attend treatment and initiate and sustain abstinence.

The purpose of the proposed research is to implement and systematically evaluate, in community treatment settings, motivational incentive procedures that have been well researched and have proven efficacious in a variety of treatment research clinics. The study will determine if motivational incentives along with standard care therapy is more effective than standard therapy alone for the treatment of patients using cocaine or methamphetamine and entering a substance abuse treatment program.

Eligibility Criteria:
Inclusion Criteria:

1. Recent admission to an opioid substitution (methadone maintenance) CTP. Completed at least 4 weeks of maintenance at time of study entry
2. Evidence of cocaine or methamphetamine use Minimum of one documented positive urine within 2 weeks of study entry. For those exiting a controlled environment, any stimulant use within two weeks of entering the controlled environment

Exclusion Criteria:

1. Unable to give informed consent (fails simple consent quiz)
2. Answers yes to question: Are you in recovery from gambling? That is, have you stopped gambling because of previous gambling problems?
Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge

This study will establish reference range intervals for the Quantra System, a next-generation diagnostic platform that provides whole blood coagulation testing at the point-of-care.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra Surgical Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system. In this multi-center, prospective, observational study, blood samples will be obtained from healthy adult volunteers to establish a normal reference range for the test parameters measured by the Quantra System.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years
* Subject is willing to participate and he/she has signed a consent form
* Subject's laboratory coagulation test results at screening are within each test's normal reference range

Exclusion Criteria:

* Subject is younger than 18 years
* Subject has a history of a coagulation disorder
* Subject is pregnant or lactating
* Subject is currently taking medications known to alter coagulation
* Subject had a blood transfusion or surgery within the last month
* Subject has one or more laboratory coagulation test result outside of the normal reference range at screening
* Drug abuse
* Excessive alcohol consumption
* Subject is unable to provide written informed consent
* Subject is incarcerated at the time of the study
* Subject previously participated in this study