cyrilzakka/clinical-trials huggingface dataset:
Myopic Macular Haemorrhages

1. To identify the underlying causes of macular haemorrhages in patients with high myopia
2. In the eyes found to have macular haemorrhages secondary to choroidal neovascularisation, we hope to identify the risk factors for the development of choroidal neovascularisation in high myopia
3. To study the functional outcome of these eyes as assessed by visual acuity
4. To study the morphological outcome of these eyes by clinical assessment (and fundal photography) and fluorescein angiography

Primary Aims

* To identify the underlying aetiologies of macular haemorrhages in myopic eyes
* To study the functional and morphological outcome of these eyes with macular haemorrhages 6 months later Secondary Aims
* To study the subgroup of eyes with myopic choroidal neovascularisation (CNV), in particular the risk factors for CNV in myopes
* To study the subgroup of eyes with macular haemorrhages in the absence of CNV

Plan of investigation:

1. Patient with myopia (\>-6.00DS) presents with loss of central vision
2. Examination reveals a macular haemorrhage
3. Investigations

   * Refraction
   * Axial length\*
   * Fundus fluorescein angiography
   * Indocyanine green angiography\*
4. Determine if a myopic CNV is present or absent
5. Management of patient: Treatment vs No treatment

   * Treatment being

     1. Conventional laser
     2. PDT
6. Review at 6 months

   * BCVA
   * Clinical appearance (fundal photo)
   * FFA
7. Review at 12 months

   * BCVA
   * Clinical appearance

Eligibility Criteria:
Inclusion Criteria:

* High myopia (greater than -6.00DS)
* Macular haemorrhage

Exclusion Criteria:

* Macular haemorrhages from other causes eg. diabetic retinopathy, hypertensive retinopathy
* Allergy to fluorescein or indocyanine green dyes
Mitochondrial Functions and Oxidative Stress in ALS Patients

In Amyotrophic Lateral Sclerosis (ALS), malnutrition is frequent (16 to 50 % of the patients) and is an independent prognostic factor. One of the implicated factors is the increase of resting energy expenditure (REE) which can be found in about 50 % of ALS patients. The origin of this hypermetabolism is currently unknown but could be located in the mitochondria. In fact, some studies have found mitochondrial abnormalities and the existence of an oxidative stress. Thus, the aim of this study is to characterize the mitochondrial abnormalities and the oxidant/antioxidant status of ALS patients and to determine their relationship with the metabolic status, hypermetabolism or normometabolism. Three groups of patients will be studied : 20 hypermetabolic ALS patients, 20 normometabolic ALS patients and 20 healthy volunteers paired for age and sex.

In Amyotrophic Lateral Sclerosis (ALS), malnutrition is frequent (16 to 50 % of the patients) and is an independent prognostic factor. One of the implicated factors is the increase of resting energy expenditure (REE) which can be found in about 50 % of ALS patients. The origin of this hypermetabolism is currently unknown but could be located in the mitochondria. In fact, some studies have found mitochondrial abnormalities and the existence of an oxidative stress. Thus, the aim of this study is to characterize the mitochondrial abnormalities and the oxidant/antioxidant status of ALS patients and to determine their relationship with the metabolic status, hypermetabolism or normometabolism. Three groups of patients will be studied : 20 hypermetabolic ALS patients, 20 normometabolic ALS patients and 20 healthy volunteers paired for age and sex.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* age \> 30 years
* definite or probable ALS according to the El Escorial criteria, bulbar or spinal form, ALS diagnosis \< 1 year and treatment by riluzole.

Exclusion Criteria:

* family history of ALS,
* oral, enteral or parenteral nutritional supply,
* vitamin or trace element supplementation
* confusing illness (cancer, diabetes, chronic infectious or inflammatory disease,thyroid disorders, recent surgery...),
* current tobacco use,
* alcoholism
* treatment by corticosteroids,
* diuretics,
* anorectics
* NSAIDs
* cytotoxics
* anticoagulants...
Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC, 11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization.

The secondary objective of this study was to determine the safety and tolerability of THC and CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index within 21.0 to 32.0 kg/m2, inclusively
* A light-, non- or ex-smoker of nicotine
* A history of recreational cannabis use (at least 10 times in the last 5 years)
* Consumed cannabis in the last 3 months before Day 1 of the study, but not within 1 month before Day 1 of the study
* Presence of intact oral mucosa
* Able to follow instructions at the training vaporizing session
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must have been without clinical significance, as determined by an investigator
* No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs), or ECG, as determined by an investigator
Single-port Versus Conventional Laparoscopic Colorectal Surgery

Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal resections, due to it's short-term benefits over conventional open surgery. In recent years, several studies have demonstrated that - in suitable patients - single-port access surgery (SPA) has similar clinical outcome compared to CL, with additional cosmetic benefits. It remains, however, unclear whether the trauma of surgery is also less for SPA compared to CL.

In this study, the investigators aim to randomise patients who are deemed suitable for SPA surgery to either SPA approach, or CL; in addition to clinical outcomes including length of operating time, post-operative pain scores, complications, quality of life indicators and cosmetic appearance, the investigators aim to compare the physiological response to trauma through biochemical markers (including C-reactive protein, White Blood Cell count) and cytokine expression (i.e. Interleukins IL-6 and IL-8). Patients will be analysed according to intention-to-treat analysis, with 25 patients in the SPA and 25 patients in the CL group. The patients will be operated by surgeons proficient in both CL and SPA surgery, and followed-up for the duration of their hospitalisation as well as at their routine out-patient visits, using questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* large bowel disorder requiring surgical resection
* body habitus suitable for single-port access surgery

Exclusion Criteria:

* patients not capable of informed consent and/or quality of life assessment
* planned open procedure for surgical reason
* multiple previous abdominal operations
* body-mass index \> 40
Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs

The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.

The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.

Gingival bleeding on probing will be evaluated before treatment. Preparation for all ceramic full coverage restoration will be performed according to manufacturer instructions by one operator. Type of finish line (whether feather edge or deep chamfer finish line) will be selected randomly according to a computer generated randomization list. Restorative margins will be placed subgingivally. Zirconia crowns will be fabricated for the prepared teeth and cemented using resin luting agent. At 6 months and 12 months after the cementation, restorative margin position relative to the gingival margin will be recorded. Bleeding on probing and marginal adaptation will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years to 50 years old
* Dentate patients planned for a single full coverage restoration in the posterior area.
* Patients with no active periodontal disease.
* \>2mm of keratinized tissue

Exclusion Criteria:

* Smoking (\>10 cigarettes a day)
* Substance abuse history
* Patients with poor oral hygiene and high caries index
* Patients suffering from abnormal occlusal habits for example clenching or bruxism
* Local or systemic disease (endocrine, renal, hematologic, hepatic, immunosuppressive)
* Current steroid/chemotherapy
* Head and neck irradiation
* Pregnancy
* Inability or unwillingness to return for follow up visits.
The Health Promoting Conversations for Families With a Critically Ill Relative

Objective: We investigated the outcomes of a nurse-led family intervention, Health Promoting Conversations, which focused on family functioning and wellbeing in families with a critically ill member.

Study design: This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups to investigate the outcomes of the nurse-led intervention in 17 families.

Outcome measures: The Health Promoting Conversations intervention was evaluated using validated instruments that measure family functioning and family wellbeing: the General Functioning sub-scale from the McMaster Family Assessment Device; the Family Sense of Coherence, the Herth Hope Index, and the Medical Outcome Short-Form Health Survey. Descriptive and analytical statistical methods were used to analyse the data.

This randomized control trial (RCT) used a pre-test, post-test design with intervention and control groups.

In the intervention group, there were 3 health-promoting conversations with each family after the discharge. The health-promoting conversations were held within an approximately 4- to 8-week period with an interval of 2 weeks between conversations. A closing letter was sent 2 to 3 weeks after the final conversation that summarized all of the conversations and that provided further opportunities for reflection.

Baseline data were collected to assess family functioning and wellbeing in the intervention group and the control group 1-2 months after the critical illness and before the start of the intervention. Follow-up assessments were conducted 3 and 12 months after the intervention for both groups. Additionally, background data, including health history, were collected using a self-administered questionnaire that asked about age; sex; education level; habits like smoking, alcohol consumption, and physical activity; psychosocial support; co-morbidity; and risk of mortality. The latter was calculated using the Charlson Comorbidity Index (Charlson et al., 1987).

The main outcome variables in this study were family functioning and family wellbeing. The following instruments were used in this study: 1) General Functioning (GF) sub-scale from the McMaster Family Assessment Device (FAD); 2) Family Sense of Coherence (F-SOC/F-KASAM); 3) Herth Hope Index (HHI); and 4) Medical Outcome Short-Form health survey (SF-36).

Eligibility Criteria:
Inclusion criteria:

* patient age \>18 years
* patient treated in the ICU for at least 96 hours
* at least one family member (age \>15 years) interested in participating

Exclusion criteria:

* dementia
* or other severe psychiatric illnesses
* drug abuse
* difficulties in understanding or reading the Swedish language
Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

We can speculate that the best responders to tocilizumab should have multiple related elements (Treg CD39, adenosine, IL-35) successfully induced and expressed in order to play its beneficial role. The study of these elements and its pathways could help identify the best responders to tocilizumab treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all sexes, aged ≥ 18 years.
* RA Patients (according to ACR / EULAR criteria 2010) of moderate to severe activity (DAS 28\> 3.2 or SDAI\> 11), and 6 months or more of evolution, starting treatment with ACTEMRA (tocilizumab) or with an anti-TNF, according to the product data.
* Patients with body weight ≤ 150 kg.
* Patients who have received written information about the study and gave their informed consent to participate in the study

Exclusion Criteria:

* Patients with a history of autoimmune disease or inflammatory joint disease other than RA.
* Patients treated with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is greater) before starting treatment with tocilizumab
Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment

The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled\* by NSAIDs.


Eligibility Criteria:
Inclusion Criteria:

1. Korean patients age ≥ 19 years old
2. Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs
3. Patients showing average NRS pain score ≥4 over the last 1 week at screening point
4. In case of previous opioids medication history, opioids wash-out period \> 30 days before enrolment
5. Patients who is willing to voluntarily sign informed consent

Exclusion Criteria:

1. Patients with any history of hypersensitivity to oxycodone, naloxone or related products
2. Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause
3. Pregnant or lactating women
Teaching Appropriate Gestational Weight Gain

The study aims to improve obstetrical care by managing gestational weight gain (GWG) among high risk women in an effort to reduce maternal and fetal complications.

The project is aimed at teaching women about the appropriate weight gain during pregnancy to optimize health outcomes for mothers and newborn babies. Obese gravida meeting inclusion criteria and none of the exclusion criteria will be offered enrollment in TAGG. Those that consent will be randomized to receive standard of care or enhanced care regarding gestational weight gain.

The primary outcome is the proportion of patients that gain less than 20 lbs over the course of the pregnancy. Secondary outcomes include patient knowledge and expectations, attitude about pregnancy weight gain, self-efficacy of ability to eat healthy, and eating, sleeping and physical activity behavior, perceived stress, psychological factors, patient-experience, involvement in care, and food security.

Eligibility Criteria:
Inclusion Criteria:

* Pre-pregnancy body mass index of at least 30 kg/m2 (per patient report of weight)
* Less than 16 weeks gestation
* Gestational weight gain (GWG) less than \< 11 pounds from their pre-pregnancy weight to time of potential study enrollment
* Singleton gestation
* Access to a phone

Exclusion Criteria:

* BMI less than 30 kg/m2
* Gestational age greater than or equal to 16 weeks
* Active diagnosis of cancer on their electronic health record problem list
* Acquired immunodeficiency syndrome (AIDS)
* Palliative medicine patients
* Multiple gestations
* GWG in excess of 11 pounds prior to study enrollment
* Patients with Non-Geisinger prenatal care providers
* Vegan diet
* Malabsorptive conditions
* Previously enrolled in TAGG during prior pregnancy. Patient will be excluded from re-randomization
* Non-English Speaking
Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission

The current study aims to investigate the feasibility of transmitting continuous and wireless vital sign data in real time from patients home to the hospital in patients discharged after an acute medical hospitalization

The healthcare system is challenged by an aging patient population with chronic diseases, and acute admissions must be housed in hospitals with fewer beds and less staff resources. This increases the need for earlier discharge and for treatment shifted to the patients' own home. Furthermore, the transition from the hospital to the home setting is one of potential hazard, due to the lack of observation and intervention possibilities.

This study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs i in the patients' own homes during the first days after discharge. Data will be transmitted continuously in real time from patient's homes to mobile applications for portable handheld devices such as healthcare personnel's smartphones.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) Admitted with an acute medical disease and scheduled for discharge to their own homes within five days from inclusion.

Exclusion Criteria:

* Allergy to plaster, plastic, or silicone.
* A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
* If the patient was deemed not able to open the front door when visited by the investigator.
* Inability to give informed consent.
Endometrial Effects of Sildenafil in Frozen-Thawed Cycles in Women With Thin Endometrium

Management of Thin endometrium in IVF is challenging. Thin endometrium is often defined as \<7 mm or \< 8 mm on the day of Human Gonadotropin administration(Bu and Sun, 2015; Wu et al., 2014).

Its incidence is 1-2.5% in most studies ( AlGhamdi et al.,2008).

Endometrial thickness and endometrial vascularity is closely linked to endometrial receptivity.Improving endometrial receptivity is a predictor of the success in IVF.

Many medications have been tried to improve endometrial thickness as Aspirin,sildenafil citrate,luteal estradiol and Granulocyte colony stimulating factor.

Nitric oxide (NO) is a key signaling molecule involved in the vasodilator response of smooth muscle cells. NO activates the cyclic guanosine monophosphate (cGMP)/protein kinase G (PKG) pathway within smooth muscle cells to promote smooth muscle cell relaxation. Sildenafil citrate inhibits phosphodiesterase 5 (PDE5) maintaining activation of cGMP and PKG and maximizing the effect of existing NO, thus facilitating smooth muscle cell relaxation. The potent vasodilator action of sildenafil has led researchers to evaluate sildenafil as a treatment in assisted reproduction where low uterine blood flow is perceived to be a contributor to implantation failure (Fairouzabadi et al.2013).

The investigators aim at this study to investigate the role of sildenafil citrate on endometrial and subendometrial vasculature in women with thin endometrium undergoing Frozen-Thawed IVF cycles.

This is a Randomised-controlled trial .The investigators recruited 100 women who are known to have thin endometrium in previous IVF cycles (failed/cancelled cycles).

They are randomised into group A (50 women) : preparation of the endometrium with Estradiol valerate 2mg/day (every 8 hours)(white tablets of cycloprogenova,Payer,Germany) from the first day of the cycle till 12th day and The investigators add placebo from the first day of the cycle till the day of starting progesterone (It will be stopped 3 days before embryo transfer).Group B (50 women): The investigators add Sildenafil citrate (Viagra,pfizer,United states) to the estradiol valerate. Sildenafil 50 mg will be used daily from the first day of the cycle till the day of starting progesterone (It will be stopped 3 days before embryo transfer). The embryos will be transferred depending on their age on day 3 or day 5.

At the transfer date ,the investigators will assess the endometrial thickness, endometrial volume, uterine artery doppler indices (RI,PI) as well as 3D endometrial vascular indices (VI,FI,VFI) .

Eligibility Criteria:
Inclusion Criteria:

* Women (25 -40 years) undergoing IVF frozen-Thawed cycles and known to have good quality embryos.
* previous thin endometrium (\< 8mm on at least 3 previous cycles) with normal Hysteroscopy findings

Exclusion Criteria:

* women less than 25 years old or more than 40 years old.
* abnormal hysteroscopic findings.
* women with congenital uterine anomalies.
* History of previous uterine surgery
* Any contraindication to Sildenafil as Previous history of cardiac disease or stroke.
RESOLUTE Asia: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Stent System in a Patient Population With Long Lesion(s) and/or Dual Vessels in Asia

The purpose of this study is to document the safety and overall clinical performance of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a patient population with long lesion(s) and/or dual vessels requiring stent implantation.

A total of 249 to 411 patients will be enrolled from Asia at approximately 25 centers where Endeavor Resolute stent is commercially available. There are two study cohorts:

1. 38 mm cohort: a minimum of 46 patients and maximum of 111 patients with at least one lesion amenable to treatment with a 38 mm length Endeavor Resolute stent. Patients may have one or two lesions, if the two lesions are located in separate target vessels.
2. Dual vessel cohort: a minimum of 203 patients and maximum of 300 patients with dual vessel treatment where each vessel has a lesion with length ≤ 27 mm and reference vessel diameters between 2.25 mm and 4.0 mm.

Eligibility Criteria:
Inclusion Criteria:

* Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
* Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
* Informed consent
* Patient agrees to comply with specified follow-up evaluations at same investigational site
* Single target lesion or two target lesions located in separate coronary arteries
* De novo lesion(s) in native coronary artery(ies)
* Target lesion(s) ≤ 35 mm in length (or both lesion lengths ≤ 27 mm for two lesions in separate target vessels to be considered for the dual vessel cohort)
* Target vessel(s) have reference vessel diameter 2.25 mm to 4.0 mm, (or 3.0 to 4.0 mm for it to be treated with a 38 mm length stent)

Exclusion Criteria:

* Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; WBC count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
* Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB \> lab upper limit of normal)
* Previous PCI of target vessel(s) within 9 months prior to the procedure
* Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
* History of stroke or TIA within prior 6 months
* Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
* Inability to comply with required trial antiplatelet regimen
* Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
* Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis
* Unprotected left main coronary artery disease