cyrilzakka/clinical-trials huggingface dataset:
Carbohydrate Restriction and Prostate Cancer Growth

No treatments have been shown to slow prostate cancer progression after radical prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (\<20 grams carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome is PSA doubling time.


Eligibility Criteria:
Inclusion Criteria:

* Received prior radical prostatectomy or definitive local radiation for prostate cancer (either external beam radiation, brachytherapy, or combination)
* PSA within the past 3 months is between 0.4 and 20 if prior radical prostatectomy, or between 3 and 20 ng/ml if prior radiation therapy.
* PSA doubling time (PSADT) \>3 months and \<36 months

  1. Calculated based at least 2 values (at least 0.2) in the prior 2 years with the first and last PSA separated by at least 3 months
  2. Use all values in the last 2 years to calculate PSADT
  3. PSADT calculated while NOT on androgen deprivation therapy (ADT).
  4. If prior ADT use, then documented either A) normal testosterone or B) a testosterone within 50 points of normal and stable (defined as a second testosterone at least 6 weeks later that is equal or lower than the first testosterone) is required before starting to calculate PSADT.
* BMI \>=24 kg/m2
* Willing to be randomized to a no-diet control or a low-carbohydrate diet
* Reads, writes, and understands English

Exclusion Criteria:

* Anticipate needing secondary prostate cancer therapy within the next 6 months (i.e. radiation, or hormonal therapy)
* Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
* Currently on therapy aimed at lowering testosterone levels (includes gonadotropin-releasing hormone (GnRH) agonist/antagonist, prior bilateral orchiectomy, oral anti-androgens, or 5-alpha reductase inhibitors). Testosterone replacement is allowed but treatment should be stable during the entire study.
* Known distant metastatic disease
* Already consuming a carbohydrate-restricted or vegetarian diet
* Unable or unwilling to adhere to a carbohydrate-restricted dietary intervention
* Weight loss \>5% of body weight in the last 6 months
* Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
Guidewire-assisted Radial A-line in Neonate and Infant

In neonate and infant, radial artery cannulation may be challenging and multiple attempts are required because of the small diameter.

The invastigators will compare the success rates of radial arterial cannulation with a guidewire-assisted technique and the direct technique in pediatric patient(\<1yr).


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing general anesthesia with arterial cannulation (for hemodynamic monitoring or blood sampling)

Exclusion Criteria:

* Skin lesion, infection, hematoma, recent cannulation at cannulation site
* Unstable radial pulse (d/t unstable vital sign, or arrhythmias)
Impact of a Clinical Pathway for Pelvic Fragility Fractures

Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence of these injuries, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practice. New insights in treatment strategies, such as early diagnosis and minimal invasive operative treatment of these fragile patient population, has led to the development of several clinical pathways in recent literature. The aim of this study is to implement an evidence and experience-based treatment clinical pathway to improve the outcomes in this fragile patient population that currently has multifactorial risks for poor outcome.


Eligibility Criteria:
Inclusion Criteria:

* Pelvic fragility fracture caused by low energetic trauma
* Patients presented at the emergency room or out-patient clinic of a participating hospital

Exclusion Criteria:

* Patients with high suspicion of a pelvic fracture due to a malignant tumor
* Patients who are unable to follow instructions due to severe cognitive decline (for example due to dementia or Alzheimer's disease)
* Patients who pre-trauma received palliative or terminal care
* Patients who pre-trauma were wheelchair bound or bedridden
* Patients who suffer from complications from previous pelvic ring fixation
* Patients with insufficient comprehension of the Dutch language to be able to carry out the physiotherapy instructions for early mobilization
Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).


Eligibility Criteria:
Eligibility Criteria

1. Previously diagnosed with moderate to severe obstructive sleep apnea.
2. Subject has failed or does not tolerate CPAP treatment.
3. Age between 21 and 70 years.
4. Body mass index (BMI) less than or equal to 40
Effect of PARP Inhibitors on Glomerular Filtration Rate

The purpose of this study is to observe whether PARP inhibitors have an effect on serum creatinine level, and whether this reflects a change in creatinine secretion or a true change in kidney function.

PARPi medications interact with transporters along the renal tubules involved in the secretion of creatinine and an increase in serum creatinine is often observed in patients treated with these agents; however, it is not known whether PARP inhibitors are associated with an actual change in the glomerular filtration rate, or if the observed elevations of serum creatinine are a result of a drug effect on creatinine secretion unrelated to changes in kidney function. The investigators therefore propose a prospective observational study to examine the incidence of elevation in serum creatinine from baseline levels in patients initiated on PARP inhibitors and compare the estimated glomerular filtration rate based on creatinine to that from alternative tests.

The primary purposes of this study are to:

* Assess the incidence of increase in serum creatinine in patients with a solid-organ cancer on treatment with a PARP inhibitor.
* To compare the estimated glomerular filtration rate based on serum creatinine with that of alternative biomarkers to assess whether changes in serum creatinine reflect changes in kidney function or creatinine secretion.
* To examine the persistence or resolution of creatinine increase and/or GFR decrease noted after discontinuation of PARPi

Eligibility Criteria:
Inclusion Criteria:

* Adult patients age 18 years or older
* Diagnosed with any solid organ cancer
* Planned to receive a PARP inhibitor (olaparib, niraparib, rucaparib, veliparib, or talazoparib)
* Able to consent to study related procedures
* If unable to give informed consent, must have healthcare proxy or legally authorized representative
* Fluent in conversational English (Informed Consent form currently in English language)

Exclusion Criteria:

* Patients who will not receive ongoing cancer care at Penn Medicine
* Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation
* Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff
* Patients on dialysis
Flexor Hallucis Longus Training and Balance-Gait in Geriatrics

Examination of Balance-Gait Parameters and Fall Effect of Flexor Hallucis Longus Muscle Strengthening Training in Geriatric Group It has been demonstrated that the reduction in the strength of the toe flexor muscles is an independent indicator of falls in geriatric individuals. However, the extent of this strength loss and the effects of strengthening training programs on balance, gait parameters, and falls are not well understood.

Objective: The aim is to investigate whether a progressive resistance exercise program, focusing specifically on the flexor hallucis longus (FHL) muscle, can improve toe flexor strength and influence gait, balance, and falls in geriatric individuals.

Materials and Methods: Individuals over the age of 65 who are willing to participate in the study will be included. The participants will be divided into three groups: individual exercise group, home exercise group, and control group. Individuals who are unable to walk independently, have severe musculoskeletal disorders, have hallux rigidus deformity, suffer from orthostatic hypotension, have difficulty understanding instructions, or have diabetic neuropathy will be excluded from the study. After obtaining socio-demographic information from the participants, anthropometric measurements will be taken. Toe grip strength will be assessed using a digital dynamometer, and the strength of the intrinsic foot muscles and lower extremity antigravity muscles will also be measured using a digital dynamometer. Balance parameters will be evaluated using the Berg Balance Scale, Functional Reach Test, Timed Up and Go Test, while gait parameters will be assessed using the 10-meter walk test and Tinetti Gait Scale. Fall parameters will be assessed by the Falls Efficacy Scale and fall frequency.

The collected data will be analyzed using SPSS (Statistical Package for Social Sciences) software.


Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 65,
* Individuals who do not have hearing or speech problems,
* Individuals who do not have any neurological, orthopedic or visual problems that would prevent walking (can walk 10 meters independently)
* Individuals who score 24 points and above in the Mini Mental Test evaluation.

Exclusion Criteria:

* Those who cannot walk independently,
* Those with serious musculoskeletal system disorders,
* Those with hallux rigidus deformity,
* Those with orthostatic hypotension,
* Those who have difficulty understanding instructions and those with diabetic neuropathy.
Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.

Organ transplant patients who participated in a retrospective study and received 2009 Pandemrix vaccine during autumn 2009 are included in this study.

The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison to healthy controls. The secondary aim is to examine the booster effect of 2010 Fluarix in patients and controls.Side effects to Fluarix vaccine are registered.

Organ transplant patients and staff members of the Transplant Institute who were vaccinated 2009 and received 2 doses of 2009 H1N1 influenza vaccine (Pandemrix) will be asked to participate in the study.

Serum samples will be collected approximately one year after completed vaccination with Pandemrix and analysed for haemagglutination -inhibiting antibodies against H1N1.The frequency of individuals with remaining protective titers will be examined.

The same individuals will be vaccinated with Fluarix containing antigen from Influenza A California/7/2009(H1N1, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008. The booster effect will be measured one month later.

Eligibility Criteria:
Inclusion Criteria Cohort number 1: Organ transplant patients who were vaccinated with Pandemrix 2009 and written informed consent received

Cohort number 2: Staff members who were vaccinated with Pandemrix 2009 and written informed consent received

Exclusion Criteria:

Patients or controls who are allergic to formaldehyde, gentamycin sulphate or natrium deoxycholate or have other contraindications against to Fluarix vaccination.
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years

The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.


Eligibility Criteria:
Inclusion Criteria:

1. 13 to 17 years of age inclusive at screening.
2. Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.
3. Written patient assent (as appropriate).
4. Confirmed malignancy.
5. Scheduled to receive 2 or more cycles\* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.
6. Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis.

   * The cycles of chemotherapy must be consecutive (i.e. one followed by the other) but do not have to be the first and second cycle of a line of treatment.

Exclusion Criteria:

1. Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster.
2. Clinical or laboratory signs and symptoms of significant cerebral, cardiovascular, respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the Investigator's judgment may interfere with the study assessment or completion of the study.
3. Patients with a known history or predisposition to cardiac conduction interval abnormalities, including QT Syndrome, or known family history of long QT Syndrome or taking medications that are known to prolong the QT interval.
4. Patients scheduled to have routine surgery during the study duration.
5. Patients with a life expectancy of \< 6 months.
6. Scarring or significant skin disease on both upper arms.
7. Female patients who are pregnant or breast-feeding. All post menarche female patients must have a pregnancy test at screening.
8. Patients who are known or thought to be sexually active must use effective birth control.\*\*
9. Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
10. Any conditions associated with non-compliance.

    * Effective birth control includes absolute abstinence, or double barrier birth control methods, i.e. condom and one of the following: combined oral contraceptive, diaphragm, depot contraceptive injection.
Regenerative Treatment of Peri-implantitis

The purpose of this study is to study the use of a new type of d-PTFE membrane called reinforced PTFE Mesh (RPM) with dental surgery. The regenerative outcomes of RPM membranes and collagen membrane for surgical reconstructive treatment of peri-implantitis (gum disease around implants) will be compared.

Peri-implantitis is an inflammatory response that leads to irreversible loss of implant supporting bone. This study will investigate the regenerative outcomes obtained with two membranes for surgical reconstructive treatment of peri-implantitis defects when the implant is submerged and primary wound closure is obtained. In one group the newly designed d-PTFE membrane with macropores, known as the RPM membrane will be utilized, which will be compared to the traditional collagen membrane used in the other group. The clinical, radiographic, and histologic outcomes for the regenerative treatment of peri-implantitis when utilizing the same bone graft in combination with either a collagen membrane or the RPM will be evaluated via a parallel-arm randomized controlled clinical trial.

32 patients with peri-implantitis will be recruited and randomized to receive peri-implantitis treatment with either a collagen membrane or an RPM membrane.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
* Subjects having at least one dental implant with peri-implantitis according to the definition proposed by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018):
* Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
* Correct 3-dimensional implant positioning, or buccal position ≤ 1 mm
* Implants which have been in function for at least 6 months

Exclusion Criteria:

* A clearly mal-positioned dental implant
* Significant interproximal horizontal bone loss (more than 50% of implant fixture length)
* A mobile dental implant
* Presence of uncontrolled or untreated periodontal disease
* More than 2 weeks usage of antibiotics in the past two months
* Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c \> 8)).
* Pregnant subjects or individuals attempting to get pregnant (self-reported)
* Subjects smoking more than 10 cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)
* Subjects unable to maintain adequate oral hygiene (O'Leary plaque index more than 50%) (O'Leary et al., 1972)
* Any other contraindications for undergoing periodontal surgery
Pre and Post Arthrogram Ultrasound Images of Joints

The purpose of this study is to determine the usefulness of contrast in ultrasonography of the joints.

To determine if using intra-articular contrast (contrast injected into a joint) will provide clearer, more precise ultrasound images of the joints then an ultrasound done without the use of a contrast agent.

Eligibility Criteria:
Inclusion Criteria:

* clinically ordered arthrogram

Exclusion Criteria:

* pregnant women
* children under the age of 18
Stress in Medical Staff and Controls

It is expected that medical personnel is exposed to more work-related psychic stress compared to controls and that this burden manifests itself by an increased activity level of the resulting in higher cortisol levels and a decreased HRV. In addition, one is interested in the stress-response/coping strategies of the individuals and believe that regular physical activity might "buffer" the influence of stress on the HPAA-hormones and HRV.

Background Medical personnel is increasingly exposed to psychological stress e.g. caused by work intensification combined with time pressure, fear of job loss, lacking appreciation and/or freedom of decision, causing psychopathological or psychosomatic symptoms involving, inter alia, the cardiovascular system. The aims of the present study are the investigation of the current amount of work-related psychological stress, its perception and underlying reasons, as well as applied recovering strategies (e.g. physical activity) in Austrian health care professionals and in controls.

Material and methods In total, 140 female and male participants (70 participants belong to medical staff; 70 participants belong to non-medical staff) between the ages of 25-65 years will be recruited. The individual stress perception will be evaluated using questionnaires (e.g. Trier Inventory for Chronic Stress, TICS; Brief Symptom Inventory, BSI-18, Short Work Evaluation). 24h salivary cortisol (at 5 time points) and heart rate variability (HRV) measurement will be performed to objectify the influence of stress on the physical body. The physical activity level will be tested by performing a cardiopulmonary exercise test (bicycle spiroergometry).

Expected results From the present study the investigators expects insight into: first, the individual perception of work-related psychological stress among health care professionals compared to the controls; second, the association of occupational stress, HRV and laboratory stress parameters and third, the role of a good physical performance on psychological stress perception.

Eligibility Criteria:
Inclusion Criteria:

* female and male participants aged 25-65 years
* for Group 1: Affiliation to medical staff
* for Group 2: No Affiliation to medical staff

Exclusion Criteria:

* Age \<25 or \>65 years
* Body weight \>130 kg
* Current pregnancy
* Anamnestic current infectious or oncologic disease
* Disability to perform a bicycle stress test
* Atrial fibrillation
* Pace maker/ICD implantation
* Current cortison and/or dexamethasone therapy
Pupillary Diameter Under Different Concentrations of Propofol

Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic.


Eligibility Criteria:
Inclusion Criteria:

* patient who has reached puberty
* ASA I or II who is scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* neurologic, metabolic, ocular disease
* chronic pain
* under medication that interferes with autonomic nervous system
* obesity
* patient requiering a rapid sequence induction
Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China

The aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections in China.


Eligibility Criteria:
Inclusion Criteria:

* Who had fever (\>38.0ºC)
* At least two of the following symptoms: chills, headache, myalgia, fatigue, nasal symptoms, sore throat, cough
* Started therapy within 48 hours of onset of influenza-like illness
* Written informed consent

Exclusion Criteria:

* Respiratory diseases, such as asthma or COPD
* Woman with a positive urine pregnancy test
* Woman without contraception during the study
* Allergic to zanamivir, Paracetamol or lactose
* WBC ≥ 10.5×109/L; neutrophil percentage ≥ 80%
* Hepatic function impairment: AST ≥ 2×ULN, ALT ≥ 2×ULN
* Renal function impairment: Cr \> 221μmol/L
* Influenza vaccination in the 12 months prior the beginning of the study
* History of tumor, psychiatric disorders, epilepsy or drug abuse
* Patients receiving corticosteroids, immunosuppressants
* HIV positive
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 30 mg/day or 60 mg/day as adjunctive therapy to donepezil 10 mg/day, and a 4-week safety follow-up period following study completion or withdrawal from treatment.

Eligibility Criteria:
Inclusion Criteria:

* The patient has a knowledgeable and reliable caregiver.
* The patient is an outpatient.
* The patient has probable AD.
* The patient has mild to moderate AD.
* Stable treatment with donepezil.
* The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.
* The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.

Exclusion Criteria:

* The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.
* The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.
* The patient has evidence of clinically significant disease.
* The patient's donepezil therapy is likely to be interrupted or discontinued during the study.
* The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.

Other inclusion and exclusion criteria may apply.