cyrilzakka/clinical-trials huggingface dataset:
The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)

The purpose of the study is to investigate the effects of memantine in ALS patients using functional outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* El Escorial Classification of laboratory supported probable, probable,or definite ALS
* Age 18 - 80 years,
* ALS symptoms for no more than 3 years,
* FVC greater than or equal to 60% predicted,
* Riluzole naïve or have been on a stable dose of Riluzole for at least 2 months,
* Patients must have the ability to attend monthly study visits in Edmonton or Calgary, Alberta

Exclusion Criteria:

* Presence of significant sensory abnormalities, dementia, other neurologic diseases, uncompensated medical illness and psychiatric illness
* Female patients who are breastfeeding
* Use of concurrent investigational drugs,
* Patient unlikely to comply with study requirements
* Poor adherence to study protocol during run-in phase
The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems

This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.


Eligibility Criteria:
Inclusion Criteria:

1. They are of legal age and capacity to volunteer.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They agree not to participate in other clinical research for the duration of this study.
5. They have a contact lens spherical prescription between - 0.50 to - 6.00 (inclusive)
6. They have a spectacle cylindrical correction of -1.00D (Diopters) or less in each eye.
7. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
8. They currently use silicone hydrogel soft contact lenses.
9. They are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day).

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They have had cataract surgery.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or lactating.
8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Causes of Mortality in Kidney Transplant Recipients

The causes of mortality in kidney transplant patients and the risk factors for mortality have been widely published. However, there is a high variability according to geographical areas and time. Recent studies suggest that the classical hierarchy of causes of mortality, i.e. the predominance of cardiovascular causes of death, could be overturned by the increase in infectious and cancer-related deaths. Investigators will try to highlight this paradigm shift and the related risk factors by studying two large French transplantation databases.


Eligibility Criteria:
Inclusion criteria:

* Adult subject (≥18 years old) during transplantation
* Transplantation performed between 01/01/2008 and 31/12/2014
* Kidney transplant subject, double transplants kidney + pancreas, or kidney + islets of Langherans
* Subject previously transplanted other organs
* Subject not objecting, after being informed, to the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject having received a double transplant during the same operation: kidney + heart, kidney + liver, kidney + lungs
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype

This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18-70 years of age
* Chronic HCV infection
* Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed
* Monoinfection with HCV genotype 1a or 1b
* HCV RNA \> 10\^4 IU/mL at Screening
* IL28B CC genotype
* HCV treatment naïve
* Candidate for PEG/RBV therapy
* Body mass index (BMI) between 18 and 36 kg/m2
* Creatinine clearance \>= 50 mL/min
* Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline

Exclusion Criteria:

* Exceed defined thresholds for key laboratory parameters at Screening
* Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed
* Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study
* Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment
Usability Study of the Focus Touch™ Conception System: Semen Collection

This is a human factors usability study designed to validated usability by obtaining feedback in a home use environment regarding ease of use of the Focus Touch™ Conception System Conceptacle (when used to collect semen) and the instructions for use. The investigators will collect data to demonstrate that the usability requirements of the conception system as collection device, as determined by Usability Specification: Focus Touch Conception System, ER-000001 have been met. The ability of the device to be used during sexual intercourse without discomfort or injury to the female participant's vaginal/cervical tissues shall also be taken into account. Participating couples will be asked to use the Focus Touch™ Conception System Conceptacle (in condom form), using the Instructions For Use, to collect semen during sexual intercourse in a home use environment. This study will involve sexual intercourse between monogamous, heterosexual couples who are trying to conceive or are on a non-vaginal birth control with which they do not normally use condoms. Participants will be asked to complete the study and the questionnaire within 3 days of receiving the study packet. Contact information shall be collected, but participants will only be contacted if they fail to return the questionnaire within the requested timeframe.


Eligibility Criteria:
Inclusion Criteria:

* Heterosexual, monogamous couples, of any race or ethnicity, who are sexually active
* 20 - 50 years of age
* Signed Informed Consent
* Past experience with using condoms
* Trying to conceive or using a non-vaginal birth control with which they do not normally use a condom.

Exclusion Criteria:

* Vaginal tract medical interventions with the last three (3) month
* Vaginal prolapse
* Full Hysterectomy
Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Lowering LDL Cholesterol in Hypercholesterolemic Patients

The trial compared AI-guided and standard physician-guided dietary supplement (DS) prescriptions for lowering LDL cholesterol (LDL-C) in hypercholesterolemic patients. The AI system used genetic, metabolic, and clinical data to personalize DS regimens, hypothesizing superior efficacy over traditional methods. This 3-month randomized, controlled trial involved adults aged 40-75 with specific LDL-C levels, excluding those with significant health risks. Participants were divided into a control group with physician-guided DS and an AI-guided group. The AI system from Triangel Scientific provided dynamic, personalized recommendations. Baseline and follow-up measurements included lipid profiles and adherence assessments. The AI-guided group showed significantly greater LDL-C reduction and improvement in other lipid markers. The study concluded that AI-guided DS prescriptions are more effective, suggesting a promising future for AI in personalized cholesterol management.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 75 years.
* LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.

Exclusion Criteria:

* Personal history of cardiovascular disease or high risk (≥ 20%).

  * Triglycerides (TG) ≥ 400 mg/dL.
  * Body Mass Index (BMI) ≥ 35 kg/m²
  * Use of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months.
  * Diabetes mellitus.
  * Known severe or uncontrolled thyroid, liver, renal, or muscle diseases.
Metabolic and Physiological Stress During Skiing.

Problem description In industrialized countries there is a rapid increase in the number of senior citizens. In Austria more than 50% of the population is overweight, with highest prevalence in the age group from 60 to 74 yrs and the WHO lists physical inactivity as one of the main behavioral risk factors of cardiovascular diseases.

Especially in winter months, activity related energy expenditure was 40% and 31% lower in the US and Canada, respectively. In addition, in an Austrian study the winter season was associated with higher blood pressure, total cholesterol and body mass index, giving an increasing risk of chronic coronary disease by 6.8% in men and 3.6% in women.

Therefore, the development of intervention programs that overcome the winter physical activity deficit and be feasible also for elderly should be goal of future research. Alpine skiing (AS) and cross country skiing (XCS) have a long standing tradition in Austria and could potentially fill the winter physical activity gap. The Salzburg Skiing for the Elderly Study (SASES) has found AS to be a save and feasible possibility to improve the health of the aged population in many parameters. XCS as a competitive sport is already well explored but there are hardly any studies about its effects in the normal or elderly population. Unfortunately knowledge about the differences between AS and XCS in the physiological adaptation processes in the elderly population is also lacking.

Aims and hypotheses of the pre-study In order to standardize training interventions, the present pre-study aims at comparing physiological and metabolic parameters between AS, XCS and IT. Therefore, the results of the pre-study serve as determinants for the training parameters of the above mentioned main study.

We postulate that, based on the results of the present study, it is possible to set up comparable isocaloric training sessions for AS, XCS and IT for elderly and unfit persons.

Furthermore, we assume that elderly and unfit subjects are able to perform a full spectrum of intensities and techniques necessary to set appropriate stimuli for isocaloric comparison.

We hypothesize arterial stiffness indices and circulating microRNA (miRNA) patterns to change due to one bout of physical activity of AS, XCS, and IT with variations depending on the kind of sport.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* male or female
* age: 30+ years
* inconspicuous ECG
* Non-smoker for at least one year
* proper skills in alpine skiing and cross-country skiing

Exclusion Criteria:

* Participation in other clinical trials at the same time or within the previous 6 months
* Tiffeneau-Pinelli index: Forced Expiratory Volume in first second (FEV1) / Forced Vital Capacity (FVC) \<60% with/without symptoms (coughing, sputum) or other evidence of a pulmonary disease
* medical condition which conflicts with participation in training
* Intake of anticoagulants
* Alcohol or drug abuse
* Severe obesity: BMI \>40
Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia

This study aims to investigate the feasibility of combining Cognitive Remediation Therapy (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be randomly assigned to one of two groups: one group will receive FBT and CRT, and the other group will receive FBT and art therapy.


Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for anorexia nervosa Lives with at least one English-speaking parent who is willing to participate Medically Stable Endorses obsessions/compulsions Adequate transportation to clinic Proficient at speaking, reading, and writing English

Exclusion Criteria:

* Previous FBT or CRT for AN Medical Instability Medical condition that may affect eating or weight
Chaplain-Delivered Compassion Meditation to Improve Quality of Life in Patients Receiving a Stem Cell Transplant

This clinical trial tests whether chaplain-delivered compassion centered spiritual health (CCSH) works to improve quality of life in patients receiving a stem cell transplant. Compassion Centered Spiritual Health (CCSH) is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling negative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others, Compassion Centered Spiritual Health (CCSH) may help improve response to stress and reduce inflammation.

PRIMARY OBJECTIVE:

I. To examine the feasibility, adoption, extent of implementation, and fidelity of chaplain-delivered Compassion Centered Spiritual Health (CCSH).

OUTLINE:

Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT: Within 6 weeks of scheduled hematopoietic stem cell transplant (HSCT)
* PATIENT: \> 18 years of age
* PATIENT: Speak and read English
* CHAPLAIN: Emory Healthcare Chaplain

Exclusion Criteria:

* CHAPLAIN: There will be no exclusion criteria and no consequence to the chaplains for refusing to volunteer
* PATIENT: Neurologic or cognitive problems that preclude chaplain-delivered Compassion Centered Spiritual Health (CCSH)
BOTOX® in the Treatment of Crow's Feet Lines in China

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).


Eligibility Criteria:
Inclusion Criteria:

-Moderate to severe Crow's Feet Lines.

Exclusion Criteria:

* Current or previous treatment with botulinum toxin of any serotype for any condition within the last year
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Facial laser or light treatment, microdermabrasion or chemical peels within 3 months
* Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent soft tissue fillers within 1 year
* Any medium-depth or deep facial peels within 5 years
* Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent soft tissue fillers, synthetic implants or autologous fat transplant.
Natural History and Patient Journey in Dementia: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.

The trajectory of dementia patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the dementia incidence, mortality and case-fatality, we implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident dementia.


Eligibility Criteria:
Inclusion Criteria:

* We identify individuals aged 30 years or older and registered in the current primary care practice for at least one year.

Exclusion Criteria:

* Individuals are excluded if they had a prior history of dementia before study entry.
SARS-CoV-2 Infection Among Healthcare Workers

At present, COVID-19 vaccine is considered as the safest, economic and effective measure to prevent and control COVID-19. Adaptive immunity, including humoral immunity and cellular immunity, plays a role in anti-viral responses. Cellular immunity includes virus specific B cells and T cells, which can provide long-term memory immunity. For acute viral infection, neutralizing antibody is of great significance in preventing infection, while memory cell immunity can maintain a good broad-spectrum and persistence in controlling mutant strains, which is a key factor in controlling viral replication after infection and reducing severe disease and death. However, there is no systematic study on the specific immune response and infection risk of novel coronavirus, and there is no definite conclusion on which specific protective immune response induced by vaccine can reduce the risk of infection. Therefore, this study aims to establish a prospective real-world cohort, analyze the correlation between multiple baseline immune protection indicators and infection risk, follow up the population with breakthrough infection, and monitor the dynamic specific immune response to COVID-19 in peripheral blood and respiratory mucosa. This study will provide an important scientific basis for us to scientifically assess the risk of individual infection with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. SARS-CoV-2 nucleic acid testing showed negative within 72 hours

Exclusion Criteria:

1.Do not consent to enroll in this study
Fresh Versus Freeze-only After CAPA IVM on PCOS Patients

IVM (in vitro maturation) has been proved to be a more friendly treatment protocol for PCOS (polycystic ovary syndrome) patients compared with conventional controlled ovarian stimulation, with less complications (especially ovarian hyperstimulation syndrome), shorter treatment duration, lower cost, and acceptable pregnancy outcomes.

IVM (in vitro maturation) has been proved to be a more friendly treatment protocol for PCOS (polycystic ovary syndrome) patients compared with conventional controlled ovarian stimulation, with less complications (especially ovarian hyperstimulation syndrome), shorter treatment duration, lower cost, and acceptable pregnancy outcomes. CAPA (capacitation) IVM without hCG (human chorionic gonadotropin) priming, has routinely been used at My Duc hospital for nearly 3 years to replace hCG-IVM (with hCG priming) because of absolutely synchronized oocyte maturation stage and better embryo results and better pregnancy outcomes. However, with CAPA IVM, embryos are freezed-only and will be transferred in the next cycles. This process will increase the cost of freezing and thawing embryos, and increase the treatment duration, which complicates the IVM procedure and turns IVM into an unfriendly protocol to PCOS patients. Therefore, our group conducts this study to find out the effectiveness of fresh transfer protocol after CAPA IVM compared with freezing-only CAPA IVM protocol. The fresh transfer protocol for CAPA IVM is applied from previous hCG IVM protocol, with the use of hCG and exogenous estradiol and progesterone, but at different timings.

Eligibility Criteria:
Inclusion Criteria:

* Women with high AFC (≥24 Antral Follicles in Both Ovaries), including PCOS plus PCO or high AFC
* Having indications for ART
* Having ≤ 2 IVM/IVF attempts
* Permanent resident in Vietnam
* Agree to have fresh embryos transfer or freeze-only on day 3
* Agree to have ≤ 2 embryos transferred
* Not participating in another IVF study at the same time

Exclusion Criteria:

* Oocyte donation cycles
* Pre-implantation genetic diagnosis (PGD) cycles
Establishing a COVID-19 Prospective Cohort for Identification of Secondary HLH

SARS-CoV2 has become a pandemic disease putting an enormous burden on health care systems around the world. A considerable amount of patients require intensive care treatment for Covid-19 associated pneumonia. At this point there is no specific treatment, apart from supportive intensive care treatment protocols for severe COVID-19 disease.The latest reports describe massive hyperinflammation in some of the severe COVID-19 patients, which is not a typical finding in virus associated pneumonia. The H-score and the modified HLH 2004 score offer diagnostic tools, that help establishing the diagnosis of HLH. Even more important is the expert clinical judgment to establish the diagnosis of sHLH.

SARS-CoV2 has become a pandemic disease putting an enormous burden on health care systems around the world. The course of disease is relatively mild in most of the patients, but there is a considerable amount of patients that require intensive care treatment for Covid-19 associated pneumonia. At this point there is no specific treatment, apart from supportive intensive care treatment protocols for severe COVID-19 disease.The latest reports describe massive hyperinflammation in some of the severe COVID-19 patients. The H-score and the modified HLH 2004 score offer diagnostic tools, that helps establishing the diagnosis of HLH. Moreover expert clinical judgment is key to establish a diagnosis of sHLH. Still, so far no systematic analysis has been carried out answering the question as to whether or not these patients suffer from secondary HLH and could potentially benefit from immunomodulatory drugs.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 17a
* diagnosis of SARS CoV 2 by PCR testing
* Hospitalized due to clinical severity of the disease
* written and informed consent or consent of the family
* GFR\<30 is not an exclusion criterion

Exclusion Criteria:

* not fulfilling the inclusion criteria
* missing written and informed consent