cyrilzakka/clinical-trials huggingface dataset:
Sexual Functioning After Primary Treatment of Ovarian Cancer

The purpose of this study is to help us learn more about sexual problems after treatment for ovarian cancer. At this time, we do not know how many women have sexual problems after they are treated for ovarian cancer.

How common are sexual problems after treatment for ovarian cancer?

* What factors make women more likely to have sexual problems after treatment for ovarian cancer?
* What happens to sexual functioning over the first 12 months after treatment? ie.

Does it get better or worse?

• Does referral to a specialized sexual health clinic help?


Eligibility Criteria:
Inclusion Criteria:

* Women with any stage of invasive epithelial ovarian cancer who have completed frontline therapy within the past 6 months
* Women must have no clinical evidence of disease
* At least 18 years of age
* English speaking
* Able to participate in the informed consent process
* Women who present to Sexual Health Clinic for the first time and meet all other eligibility criteria are eligible. Their FSFI scores will be used to determine the primary endpoint of prevalence of sexual dysfunction. If they score over 26 on the FSFI, they may still elect to be followed at the SHC.

Exclusion Criteria:

* Active secondary cancer requiring cytotoxic chemotherapy at the time enrollment
* Evidence of recurrent/persistent disease by elevated CA125, findings on imaging (CT, PET scan etc) or physical examination
* Women with borderline (low malignant potential) ovarian cancers
* Women who are already in active evaluation and/or follow-up at the Sexual Health Clinic
* Women with a history of prior whole pelvic radiation
Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury

Building on recent improvements, state-of-the-art functional MRI will be applied as an advanced diagnostic tool for the lumbosacral cord in spinal cord injury (SCI) patients to characterize the remaining neuronal activity of the motor and sensory neurons. Alterations in the activity pattern will reveal the effect upon task-related spinal cord activity of the lower motor neurons and sensory neurons undergoing trauma-induced neurodegeneration, at a spatial specificity that has not been possible so far. Results of this study will be of crucial importance because SCI patients can only profit from regeneration-inducing therapies if spinal neuronal function is preserved below the level of lesion.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Informed consent
* Willing to take part and follow requirements of the protocol

Patients additionally need to fulfil the following study-specific inclusion criteria:

Cross-sectional study:

* Chronic traumatic SCI (\> 12 months after injury) or
* Diagnosed degenerative spondylotic myelopathy (DCM)

Longitudinal study:

* Acute traumatic SCI (\< 2 months after injury) or
* Patients with neurogenic lower urinary tract dysfunction (NLUTD) who undergo routine tibial nerve stimulation (TNS) treatment as part of their rehabilitation (but independently of this study) at Balgrist University Hospital

Exclusion Criteria:

* Age \< 18 years
* Contraindications for MRI (presence of pacemaker or other type of stimulator in the body, presence of metallic foreign body in or on the body, etc.); we will comply with the imaging center's (SCMI) guidelines and in case of doubt we will exclude the participant from the study
* No informed consent
* History of psychiatric or neurological disease, apart from those induced by SCI (e.g.epilepsy)
* History of skull opening or head trauma
* Known or suspected non-adherence, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Women who are pregnant (when uncertain, participants will undergo urine testing) or breastfeeding
* Intention to become pregnant during the course of the study
* Body mass index (BMI) \> 35
* Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences)
Natural History Study of Infantile and Juvenile GM1 Gangliosidosis (GM1) Patients

Owing to the rarity, severity, speed of progression and fatal prognosis of infantile and juvenile GM1, there is a limited understanding of overall disease progression and meaningful outcome measures. This study aims to build a natural history data set through collection of a number of clinical, imaging, and laboratory assessments that may be specific predictors of GM1 disease progression and clinical outcome. Having a GM1 natural history data set can inform potential efficacy endpoints and biomarkers for future clinical trials.

This natural history study will follow up to 40 subjects diagnosed with GM1 gangliosidosis (up to 20 infantile (Type 1) and 20 late infantile/juvenile (Type 2)) for up to 3 years. Visits will be conducted every 6 months, during which several procedures will be performed and the data recorded in order to learn about the natural course of the disease, including changes in clinical and neurological assessments and electrophysiologic, imaging and biofluid biomarkers. Study procedures include: physical \& neurological exam, blood \& urine sample collection, questionnaires \& assessments of development, seizure diary, ECHO, ECG, x-ray and ultrasound (if MRI not performed), EEG and genetic testing (if not already done).

The following procedures are subject to local/institutional policies and the medical discretion of the Study Physician: MRI, lumbar puncture (spinal tap) and General anesthesia/sedation (for MRI and LP).


Eligibility Criteria:
Inclusion Criteria:

1. Documentation/ Confirmation of reduced beta-galactosidase enzyme activity in leukocytes
2. Confirmed diagnosis of infantile or juvenile GM1 gangliosidosis with documentation of GLB1 mutations
3. Parent/Caregiver capable of providing informed consent (if cognitively able, child to provide assent as well)
4. Infantile (Type 1) GM1 subjects: Documented symptom onset by 6 months of age with significant hypotonia on exam or history elicited from parent(s)/ caregiver(s)
5. Juvenile (Type 2) GM1 subjects: Documented symptom onset after 6 months of age OR documented symptom onset prior to 6 months of age without significant hypotonia on exam or elicited from parent(s)/ caregiver(s)

Exclusion Criteria:

1. Enrollment in any other clinical study with an investigational product/ therapy (patients receiving miglustat off-label will be eligible)
2. Any clinically significant neurocognitive deficit not attributable to GM1 gangliosidosis or a secondary cause that may, in the opinion of the investigator, confound interpretation of study results
3. Any condition that, in the opinion of the investigator, would put the subject at undue risk or make it unsafe for the subject to participate
Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

Preliminary reports have been received from several sources that the periodic inhaling of the nebulized mist from water that has a heightened level of kinetic activity has quickly (less than 2 days) lessened the severity of symptoms in Covid-19 infected patients. On at least several occasions, a repeat PCR test performed several after inhaling a particular water-based product was negative. There are no perceived adverse effects from inhaling the water mist by using a nebulizer or humidifier. It is important, however, to validate these preliminary findings and to include the inhaling of the mist from water, which does not have an elevated level of kinetic activity. This will be by performed in a patient-blinded manner by sequentially inhaling the two types of water over consecutive 2-day periods with Covid-19 testing at the end of each of the two day periods. Participants will be randomized as to whether they are to inhale the mist from the test or the control water.

Several producers of activated water have been in frequent communication with the Principal Investigator (PI) over the last decade or longer. They have regularly supplied their water products to the PI for laboratory testing, including measuring an activity attributed to the absorption of an environmental force, referred to by the PI as KELEA, an abbreviation for Kinetic Energy Limiting Electrostatic Attraction. KELEA is regarded as the source of cellular energy for the body's alternative cellular energy (ACE) pathway. This pathway can provide a non-immunological defense mechanism against infections, presumably including coronaviruses. The proposed study is to test water products from several suppliers, as well as a naturally available source of KELEA activated water in symptomatic individuals who have tested positive by either PCR or antigen testing for Covid-19. The mode of administration will be by inhalation using a nebulizer or diffuser. Several deep inhalations will be taken on 5 occasions daily. Prior to the first inhalation and at the end of the second day of inhalation, swabs will be taken for Covid-19 PCR and/or antigen testing. Randomly allocated participants will either blindly first test the KELEA excellerated water for two days, followed by using water without an elevated level of KELEA and vice versa. The severity of symptoms will also be monitored at the end of each of the two-days periods of inhalation.

Eligibility Criteria:
Inclusion Criteria: Individuals entering into quarantine because of a positive Covid-19 test using either PCR or an authorized antigen assay. It is not necessary, but preferable, for the participant to be symptomatic for Covid-19 -

Exclusion Criteria: Unwilling to do repeat PCR and/or antigen testing or to provide the results of the repeat testing or the requested clinical data

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ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects

This study intends to provide information on the safety and tolerability of repeated oral doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best address the study goals.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be healthy males subjects between 18 and 50 years of age;
* Subjects must be in good healthy as determined by a medical history, physical examination and clinical laboratory evaluations;
* Subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the stdy restrictions.

Exclusion Criteria:

* Subjects with hypersensitivity known to Psidium guajava L. or history of serious adverse events;
* Subjects who have a significant history of alcoholism or drug/chemical abuse;
* Subjects who have body mass index \< 18 or \> 30;
* Subjects who have received any medications that is known to have a toxic potential well defined in large organs within the past 3 months prior the study start;
* Subjets who doesn´t agree to use, for the duration of the study, a barrier contraceptive;
* Subjects who were hospitalized for any reason in the six week prior the study start;
* Subjects who, in the opinion of the investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol;
* Subjects who are participating in a clinical trial or have participated in a clinical study involving administration of an investigational drug, within one year;
* Subjects who are relatives of employees from the sponsor and the site, respectively;
* Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator;
* Any finding of clinical observation (anamnesis and physical evaluation), laboratory abnormality, who in the investigator opinion, may jeopardize the subjects or interfere with the study goals.
Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in T1DM

The purpose of this study is to compare the differences of

1. cardiopulmonary fitness
2. lung function
3. muscular oxygen saturation
4. quality of life between type 1 diabetes mellitus and healthy adults.

This study is also to investigate the relationships between cardiopulmonary fitness, lung function, muscular oxygen saturation, glycemic control, and quality of life in patients with type 1 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 1 diabetes mellitus ≥2 years (diabetic group)
* age-, gender-, and BMI-matched healthy subjects (control group)

Exclusion Criteria:

* cardiac or respiratory disease
* pregnancy
* hospitalization due to any medical condition in recent 6 months
* any other condition affecting exercise performance or lung function.
Antineoplastic Drugs in Elderly Patients

The purpose is to study the population pharmacokinetics, effectiveness and safety of antineoplastic drugs (Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc) in elderly patients and recommend optimized dosage regimens.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be enrolled in the study:

1. Age ≥65 years old;
2. Diagnosed with cancer;
3. Using antineoplastic drugs for treatment.

Exclusion Criteria:

Subjects with any of the following criteria will not be enrolled in this study:

1. Patients who are expected to die within 48 hours;
2. Patients with allergy to antineoplastic drugs;
3. Patients receiving other investigational drugs;
4. Other factors that the researcher considers unsuitable for inclusion.
Fibromyalgia Acupuncture Study

The acupuncture treatment in this study is particularly aimed at reducing the pain and other negative health events such as emotional trauma and disability associated with Fibromyalgia, while improving the quality of life and promoting general health.

It is hypothesized that acupuncture treatment will be effective in reducing pain and improving lower body strength and overall functionality more than the sham acupuncture treatment in people with Fibromyalgia (FM). The purpose of this study is to compare the efficacy of acupuncture with simulated acupuncture in patients with FM using a randomized controlled design. More specifically, the objectives of this study are to determine if acupuncture can (1) reduce pain, (2) improve lower body strength, and (3) improve overall functionality.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be 18 years or older and can be of either sex.
2. A confirmed diagnosis of FM (pain for more than three months) will be required to participate in the study. If they do not have a diagnosis the study clinician or research assistant will examine them and determine their eligibility.
3. All participants must be willing to provide a written informed consent prior to participation and should not have undergone acupuncture treatment in the past.

Exclusion Criteria:

1. Acupuncture treatment in the past five years.
2. Unwilling to sign informed consent.
3. Less than a score of 40 on the Fibromyalgia Impact Questionnaire,
4. Involvement in any litigation currently or in the past,
5. Simultaneous infection with HIV/Hepatitis B virus.
6. Severe depression (Beck depression score \>21),
7. History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
8. Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical conditions (including unstable hypertension, hypo or hyperthyroidism, or psychological conditions that in the opinion of the investigators would compromise participation or be likely to lead to an adverse response, including injuries or hospitalization, during the course of the study. We will get the information from the health/activity questionnaire.
9. Have any DSM-IV Axis (major depression, addiction, anxiety) disorder which, in the judgment of the investigators, would interfere with compliance with the study protocol.
Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations

The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.

A maximum of 104 subjects will be enrolled across a maximum of 5 study sites in the United States.

The estimated duration of the study is approximately 8 months from the time of first subject enrollment to the last subject enrollment. Enrollment occurs intraoperatively after confirmation of the intraoperative eligibility criteria. Subjects will undergo intraoperative performance assessments and then will be discontinued from the study after completion of the intraoperative visit.

Eligibility Criteria:
Preoperative Inclusion Criteria

* Subject is undergoing a non-emergent cardiothoracic surgery; and
* Subject or an authorized legal representative is willing and able to give prior written informed consent for study participation.

Preoperative Exclusion Criteria

* Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
* Subject has religious or other objections to porcine or bovine components; and
* Subject is not appropriate for inclusion in the clinical study, per the medical opinion of the Investigator.

Intraoperative Inclusion Criteria

* Subject does not have an active or suspected infection at the surgical site;
* Subject in whom the Investigator is able to identify a Target Bleeding Site (TBS) for which any applicable conventional means for hemostasis are ineffective or impractical; and
* Subject has a TBS with minimal, mild, or moderate bleeding
Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery

The application of acute Normovolemic Hemodilution in cardiac surgery can effectively reduce perioperative blood transfusion, reduce postoperative complications and mortality, and is a low-cost, operable and effective blood protection measure.For the application of Acute Normovolemic Hemodilution in heart surgery, we still face an urgent problem: to what extent can Acute Normovolemic Hemodilution achieve better "blood saving effect", that is, whether a large number of Acute Normovolemic Hemodilution can reduce perioperative blood transfusion to a greater extent


Eligibility Criteria:
Inclusion Criteria:

* （1）18-75years old;（2）elective cardiac surgery under cardiopulmonary bypass; （3）Preoperative hemoglobin (Hb) ≥ 12g/dl; (4) Transfusion Risk Understanding Scoring Tool (TRUST) ≥ 2 (possibility of blood transfusion ≥40%).

Exclusion Criteria:

* （1）congenital heart disease、Cardiac tumor、aortic dissection、heart transplantation（2）Low body weight（\<50 kg）;（3）preoperative shock；（4）myocardial infarction within 3 months before surgery；（5）ischemic heart disease;Left main coronary artery stenosis \>70%;Severe aortic stenosis (area \< 0.7cm2);Severe changes in left ventricular function (ejection fraction \<30%, requiring vasoactive agents to assist circulation);（6）severe carotid artery stenosis (\>70% or with symptoms);（7） kidney failure (blood creatinine level \>442 mmol/L) or dialysis treatment;（8） serum albumin level (ALB) is less than 25 g/L.（9） international standardized ratio (INR) \>1.5 or platelet count \<100 103/mm3;（10）Inherited/acquired coagulation function defect;（11）contagious or infectious diseases;（12） patient or family members refused to participate in research;（13）refused to infusion of autologous blood or allogeneic blood products
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

This study is to provide safety information of hemoporfin during the post-marketing period as required by China Food and Drug Administration (CFDA) regulations in order to identify any potential drug related treatment factors in the Chinese population, such as unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine drug uses.


Eligibility Criteria:
Inclusion Criteria:

* Age range: 14 to 65 years-old；
* Clinically diagnosed of Port-wine Stain;
* Patients receiving hemoporfin based upon the clinical judgment of the investigator;
* Written informed consent signed and agreed to receive periodic follow-up

Exclusion Criteria:

* Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
* Scar diathesis;
* Pregnancy or unwilling to adopt reliable contraceptive measures during the month after drug application;
* Be judged not suitable to participate the study by the investigators
Hypertension and Cardiovascular Risk Factors

A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

* - Patients who give consent
* Men and women 18 to 80 years of age
* Patients with hypertension (systolic \>159 mm, diastolic \>100 mm)
* Patients meeting laboratory criteria

Exclusion Criteria:

* - Pregnant women
* Women not using approved contraception methods
* Secondary hypertension

Other protocol-defined exclusion criteria may apply.
Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical

To asses the effectiveness of implementing a diabetes management protocol (early insulinization, avoiding use of SSI) in a hearth hospital's non-intensive care unit.

Management of diabetes in patients admitted to non-intensive unit of a cardiology hospital in order to reduce the number of episodes of hypo-and hyperglycemia, improve glucose control and reducing the number of hospital days.

Eligibility criteria:

Patients with previous history of diabetes mellitus type 2, or are in use of oral antidiabetics or insulin or having fasting glucose or less 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, aged greater 18 years.

Eligibility Criteria:
Inclusion Criteria:

* Previous history of diabetes mellitus type 2, or they were using oral anti-diabetic or insulin had a fasting glucose greater than or equal to 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, age greater than or equal 18 years

Exclusion Criteria:

* Patients with known presence of cancer, while using corticosteroids, immunosuppressants on hemodialysis, with cognitive and neurological sequelae, patients whose admission had shorter duration than 72 hours, when they came transferred from intensive care units in other protocols using insulin when no doctor would agree to join the protocol and those who do not agree to participate in the study