cyrilzakka/clinical-trials huggingface dataset:
PF 06412562 in Subjects With Advanced Stage Parkinson's Disease

The purpose of this study is to test the safety and tolerability of the investigational drug PF-06412562 compared to the current medical standard of care medication for Parkinson's disease, carbidopa/levodopa. This research also is being done to find out if the investigational drug PF-06412562 can help improve the motor (movement) function, alertness, and cognitive (thinking) skills of people who are considered to be in the advanced-stage of Parkinson's disease. In this study, PF06412562 is 'investigational,' which means that it is experimental and has not been approved by the US Food and Drug Administration (FDA), but can be used in clinical research studies such as this one.

The investigators are conducting a randomized, double-blind, carbidopa/levodopa-controlled crossover safety, tolerability, and efficacy study of the investigational compound, PF-06412562, in advanced Parkinson's patients. The primary purpose of this study is to test the safety and tolerability of the investigational drug PF-06412562 compared to the current medical standard of care medication for Parkinson's disease, carbidopa/levodopa, in these patients. This secondary purpose of this research is to find out if the investigational drug PF-06412562 can help improve the motor (movement) function, alertness, and cognitive (thinking) skills of people who are considered to be in the advanced-stage of Parkinson's disease. This study will inform the field as to whether PF-06412562 is safe and well-tolerated in advanced Parkinson's patients, and also may provide preliminary data on its efficacy in several domains.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of classic PD with history of clinically meaningful response to levodopa
* Disease duration \>15 years since diagnosis
* Hoehn \& Yahr stage \>IV "on" or "off" levodopa
* Consent signed by subject, if possible
* If subject is cognitively impaired, consent signed by power of attorney or legally authorized subject representative
* Assent from the study subject, if possible
* Stable dose of all medications for 60 days prior to Day 1 of first week of study

Exclusion Criteria:

* Atypical parkinsonian syndrome (e.g., never responded to levodopa, and/or atypical signs)
* Acute or unstable medical condition such as heart disease, kidney and liver failure
* History of HIV, hepatitis B and C
* Use of moderate to strong CYP 3A4 modulators (see both inhibitors and inducers in Appendix BB)
Regional Blocks of Gynecological Surgeries

This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse Patients will be divided into three equal groups; group A control group for conventional epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre spinal needle(n=91). Randomization will be done using computer generated number and concealed using sequentially numbered sealed opaque envelope.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II
* Height(150-170 cm)

Exclusion Criteria:

* patient refusal
* hypersensitivity to local anesthetic drugs
* bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).
Reducing the Abuse Liability of Prescription Opioids

Opioid (commonly called narcotic) pain medicines are, after marijuana, the most commonly abused substances in the United States. Patients who take opioids for legitimate reasons may become addicted; for example, as many as 1 in 4 patients meet the criteria for current opioid dependence. It is very important that a way is found to provide pain relief while minimizing the addiction potential of these widely used pain medications.

The study aim to find out if the use of another type of medication given in addition to an opioid will reduce the addiction potential of the opioid.

The study is trying to find out if the ability of the opioid to relieve pain is changed when given with the other medication, and to see if the euphoric sensation or "liking" of the opioid pain medication is reduced when taken with the other medication.

This study involves the use of an investigational combination of drugs. "Oxycodone with Risperidone" and "Oxycodone with Ziprasidone" are called "Investigational" because the U.S. Food \& Drug Administration (FDA) has not approved these drug combinations for the purpose of this study. Individually, each of these drugs is approved by the FDA for other reasons (i.e. oxycodone as a painkiller, while risperidone and ziprasidone are approved as anti-psychotic medications), but the administration of these drugs together has not been studied before or been approved by the FDA for this purpose.

This is the first study involving humans to examine the safety of this combination of drugs and how they work together. The goal of the study is to find out what effects, good and/or bad, it has on people who take them. Because the combination has not been studied in humans before, information about the safety and effectiveness is incomplete and all of the side effects are not yet known.

Eligibility Criteria:
Inclusion Criteria:

* Requirement of prior exposure to opioids

Exclusion Criteria:

* Presence of psychiatric comorbidity
* Presence of chronic pain disorder
* Presence or history of substance use disorder
* Current analgesic or neuroleptic medication usage (any medication for pain, including over-the-counter analgesics like ibuprofen/acetaminophen)
* Pregnancy
* Positive drug urine test
* Continuous opioid misuse measure score of \< 9
* Presence or history of diabetes
* Presence or history of cardiac disease or arrhythmia
A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives

The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.


Eligibility Criteria:
Inclusion Criteria:

* Females of childbearing potential
* Use of Neovletta or Neovletta 28 minimum 3 months prior to enrolment.
* Willing to use a highly effective method of birth control, ie, double barrier method contraception.

Exclusion Criteria:

* Pregnancy and/or lactation or delivery/abortion within 6 months prior to randomisation.
* Any clinically significant disease or disorder.
* Any clinically relevant abnormal findings in physical examination.
Self-Management of Sleep Among Older Adults

The purpose of this study is to test the feasibility of older persons use of a personal sleep monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to 50% of persons over the age of 65 with chronic health conditions. Impaired sleep negatively influences subjective and objective health outcomes.To improve their sleep, older adults with chronic health conditions could benefit from objective information, available through personal health monitoring devices, about their current and changing sleep patterns. Based on this information, sleep self-management interventions can be individualized and shared, and associations between sleep and health changes may be better managed.


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* Self-report difficulty sleeping
* Willingness to wear the PSMD for four weeks
* Cognitive abilities (Mini Cog of 5 or above).

Exclusion Criteria:

* Under the age of 65
* Presence of known sleep disorders
* Severe cognitive or neurosensory impairment
The Effect of Labor Dance on Traumatic Birth Perception and Comfort

ne of the non-pharmacological methods that provide opportunities such as massage and freedom of movement with the support of the spouse / partner is the birth dance.

In order to reduce the pain perceived by the woman and provide emotional support, the birth dance is started in the active phase of the first phase of the labor and continues until the end of the first phase. The woman is given the opportunity to act rhythmically with a relaxing light music with someone she prefers (spouse / partner, mother, midwife, etc.). The hands of the pregnant woman dance in the form of swinging from left to right, on the shoulder of his wife, with music; The partner is massaged by the sacrum area. It is aimed to increase the effectiveness of the method applied by adding spouse / partner support, upright posture and massage in addition to the music and body movements that dance includes, and also to provide emotional support to the woman. In this study, it was aimed to evaluate the effect of birth dance on traumatic birth perception and comfort.

The study was planned as randomized controlled. Pregnant women and their accompanying persons assigned to the study group will be informed about working in the tram room where the pregnant woman is before the active phase begins 'Using the Labor Dance Practice Guide (Annex 3) and cervical dilatation 4 cm. they will be asked to practice in accordance with this guide. Details of the application (such as dance time, rest time) will be recorded in the 'Labor Dance Control Guide' (Annex 4) by the researcher. Pregnant women will be followed by the doctor and midwife responsible for the pregnancy during the tram, and the researcher will not be involved in tram follow-up of the pregnant woman (cervical dilation, pediatric heart sound, contraction follow-up, vital signs of the pregnant woman).

Eligibility Criteria:
Inclusion Criteria:

* Those who were admitted to Hospital for labor
* Those whose cervical dilatation between 4 and 8 cm.

Exclusion Criteria:

* When delivered by cesarean sectio,
* Labor was inducted
* Narcotic analgesics used
Photobiomodulation On Muscle Recovery In Professional Soccer Players

Background: Photobiomodulation with low-level laser therapy (LLLT) has been widely used in clinical practice for diverse purposes, such as modulation of the inflammatory process, acceleration of the tissue repair process, pain relief and the enhancement of post-exercise recovery. Studies have demonstrated a beneficial interaction between photobiomodulation and the production of creatine kinase, with a reduction in the release of this marker of muscle damage when laser and/or LEDs is administered prior to high-intensity physical activity. The aim of the proposed study is to determine the influence of pre-exercise phototherapy on post-exercise muscle recovery.

Methods: A randomized, cross-over, sham-controlled, double-blind, clinical trial is proposed. The participants will be healthy professional soccer players aged 15 to 20 years from the same team with a body mass index within the ideal range (20 to 25 kg/m2) and no history of lower limb musculoskeletal injuries or surgery or back surgery in the previous six months. The athletes will be allocated to two groups based on the previously calculated sample size and will be blinded to allocation. Creatine kinase will be measured and the subjective perception of fatigue will be determined for each participant. The volunteers will then be randomly allocated to Group A, which will receive active phototherapy, and Group B, which will receive sham phototherapy. The athletes will undergo reevaluations immediately after as well as 48 hours after a football match. The data will be submitted to statistical analysis and the level of significance will be set to 5%.


Eligibility Criteria:
Inclusion Criteria:

* Healthy professional soccer players aged 15 to 20 years from the same team with a body mass index in the ideal range (20 to 25 kg/m2) will be included in the study.

Exclusion Criteria:

* A history of musculoskeletal injuries and/or surgeries in the lower limbs or back surgery in the previous six months
Sympathetic Nerve Activity During Hypoglycemia and Exercise

The purpose of this study is to determine if either hypoglycemia or exercise cause differential responses in muscle and skin sympathetic nerve activity.

The body has defensive responses to correct low blood sugar (hypoglycemia). A vital component of this response is release of glucagon and activation of the sympathetic nervous system, which provides the means for raising blood glucose levels towards normal. We can measure circulating hormones indicating the level of these responses, but additionally, sympathetic nervous system responses can be measured directly. We can measure the sympathetic nerve activity that controls blood flow to muscles (MSNA) and blood flow and sweating to skin (SSNA). The purpose of this study is to determine if either hypoglycemia or exercise cause differential responses in muscle and skin sympathetic nerve activity. We would also like to determine what the sympathetic response is to cycling exercise with insulin and normal blood sugar. Therefore, we would like to test the sympathetic responses to insulin with normal blood glucose, hypoglycemia, and during exercise bouts and normal blood glucose, with or without insulin.

Eligibility Criteria:
Inclusion Criteria:

* 36 Healthy male and female subjects (18 males and 18 females) aged 18-40 yr
* All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities
* Body mass index ≤30kg · m-2
* Normal bedside autonomic function
* Female volunteers of childbearing potential will undergo HCG pregnancy test at screening and again on the study day.

Exclusion Criteria:

* Pregnant women
* Subjects unable to give voluntary informed consent
* Subjects on anticoagulant drugs or anemic
* Subjects with a recent medical illness
* Subjects with a history of hypertension, heart disease or cerebrovascular disease
* Subjects with known liver or kidney disease
* Subjects with recent weight loss or consuming a low carbohydrate diet
Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure

The main objective of this study is to compare pholcodine exposure in patients having presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine exposure in matched anaesthetised patients with injection of NMBA, who did not present with an anaphylactic reaction (controls).

The secondary objectives of the study are:

* To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.
* To study the concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.
* To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.
* To study the association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.
* To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to (at least) one NMBA.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥ 2 years old.
* Referred to anaesthesia-allergy consultation within (approximately) 6 to 12 weeks of occurrence of peranaesthetic anaphylactic reaction during anaesthesia with administration of NMBAs (only for case patient).
* Having given his/her consent (or the 2 parents consent for minors).
* Affiliated with a social security scheme or dependent.
* Able to answer a medicinal product intake questionnaire
* In a clinical condition compatible with skin tests (no skin disease or psychiatric illness, etc.) (only for case patient)
* Having stopped any anti-histamine treatment at least 8 days previously (only for case patient).
* With positive skin test for the suspected NMBA (ony for case patient).
* Patient anaesthetised in a control recruitment centre (only for control patients)
* Having undergone anaesthesia with NMBA injection, without onset of peranaesthetic anaphylactic reaction whatever his medical history (only for control patients)

Exclusion Criteria:

* Patients who have refused, or are unable to give their consent
* Patients who have had negative control skin tests
* Anaphylaxis suspected to be related to other drugs given on induction of anaesthesia, eg. antibiotics
* Having presented with anaphylactic reaction during a previous anaesthesia without NMBA injection
* Pregnant females at inclusion or during 12 months before anaesthesia
Treatment of Sudden Deafness With Prednisone+Hyperbaric Oxygen and Prednisone+Somatosensory Stimulation

To study the effective treatment of sudden deafness by giving prednisone, hyperbaric oxygen and somatosensory stimulation to sudden deafness patients.

60 cases of sudden deafness within 2 months of 14-80 years old were randomly divided into two groups. They underwent hearing tests, magnetic resonance imaging of the head, and routine hospital admissions. One group was given prednisone for 1 mg / kg body weight × 7 days + somatosensory stimulation × 30 days, the other group was given prednisone for 1 mg / kg body weight × 7 days + hyperbaric oxygen × 15 days, and repeated electrical audiometry every week. One month and three months after the experiment, repeated audiometry.

Eligibility Criteria:
Inclusion Criteria:

* Sudden deafness
* History within 2 months
* Age 14-80

Exclusion Criteria:

* Neurological diseases (such as brain tumors)
* Patients with mental / mental illness undergoing treatment
* Pregnant women and patients with other untreatable diseases
* Finding the cause of sensorineural deafness
* Patients Not Suitable for Hyperbaric Oxygen
* A patient with dermatosis
Impact of Physical Activity on Patients With Chronic Kidney Disease Not Receiving Dialysis Followed in the TIRCEL Network. An Exposed / Unexposed Study (PHYSALYS)

PHYSALYS is an observational multicenter study. It's an analytical study comparing 2 groups: patients exposed to physical activity and unexposed. The main objective of the study is to compare the evolution of glomerular filtration rate at inclusion and 12 months later between patients practicing physical activity and patients not practicing. If necessary, the renal disease-related complications, which are not influenced by physical activity: (type of kidney disease, age and tobacco), would be taken into account. TIRCEL patients with chronic kidney disease (CKD) at stages 3, 4 or 5 can be included in the study. Their serum creatinine data, 12 months prior to inclusion, is collected retrospectively. Patients are followed in the trial during 12 months. To evaluate physical activity, patients respond to Global Physical Activity Questionnaire 2 (GPAQ2) at inclusion and 12 months later. During this 12 months period, the same biological data are collected prospectively.


Eligibility Criteria:
Inclusion Criteria:

* Members of TIRCEL (Traitement de l'Insuffisance Chronique en rhônE-aLpes) network for over a year and having at least two measurements of glomerular filtration rate with an interval of 9 to 12 months between the first and the last measurement
* Patients in stages 3, 4 or 5 of CKD
* No dialysis CKD patients
* Non transplanted CKD patients
* Patients seeing nephrologist
* Patients agreeing to be contacted for a phone call half an hour
* Adults patients (\> 18 years)
* Patients not living in institution
* Patients being able to answer a questionnaire

Exclusion Criteria:

* Patients followed in the TIRCEL (Traitement de l'Insuffisance Chronique en rhônE-aLpes) network for less than one year or having less than 2 measurements of glomerular filtration rate with an interval of least 9 months or over 12 months between the first and the last measurement
* Patients in stages 1 or 2 of CKD
* CKD patients receiving dialysis
* Transplanted CKD patients
* Patients not seeing nephrologist
* Patients refusing to be contacted for a phone call half an hour
* Patients \< 18 years
* Patients living in institution
* Patients unable to answer a questionnaire
Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day
* Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive)
* Body Mass Index (BMI) below 45.0 kg/m\^2

Exclusion Criteria:

* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (MAO) inhibitors
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Known proliferative retinopathy or maculopathy requiring treatment according to the investigator
* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening
* Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening
Philani Home-based Nutrition Intervention Program

Malnourished children and babies with birth weights under 2500 grams are at high risk for negative outcomes over their lifespan. Philani, a paraprofessional home-visiting program, was mounted in neighborhoods in three townships in Cape Town, South Africa, from 2002 to 2004 to improve nutritional outcomes.

One mentor mother was recruited from each of 37 neighborhoods. Mentor mothers were trained to conduct home visits to weigh children and to support mothers to problem-solve life challenges, especially around nutrition. Households were randomly assigned on a 2-to-1 ratio to the Philani program or to a standard care condition. Children were evaluated over a 1-year period.

The investigators hypothesized that children in the intervention would gain more weight than children in the control.


Eligibility Criteria:
Inclusion Criteria:

* mother or caregiver
* with child under 5 years of age and malnourished (malnourished if less than 2 standard deviations below the World Health Organization normative mean weight for the child's age

Exclusion Criteria:

* no malnourished children under care
* malnourished children not living in household