cyrilzakka/clinical-trials huggingface dataset:
Dissecting the Role of Estradiol in Mediating Gender-specific Anxiolytic and Prosocial Effects of Oxytocin

The study aims to examine a behavioral and neural framework for understanding the sex-specific effects of the neuropeptide oxytocin (OXT). Using hormonal, behavioral and neuroimaging readouts, it is planned to explore the interplay of OXT and estradiol as a potential mechanism mediating sexual dimorphic effects.

The study comprises two subprojects (Study 1 and Study 2). In Study 1, the investigators will compare the effects of OXT on fear extinction and fear recall as well as on emotion recognition between women and men. Additionally, the investigators plan to test whether a pretreatment with exogenous estradiol can be used to augment these OXT effects. In Study 2, the investigators will use functional magnetic resonance imaging (fMRI) to elucidate the effects of OXT-estradiol interactions on neural responses in an emotional face matching task and an emotional memory task. Half of the participants will be included in Study 1 and the other half in Study 2.

Study 1 contains three test sessions (after the screening). In the first session participants will complete a fear conditioning paradigm. The second session will take place on the following day and will start with the administration of estradiol gel (Divigel; 2 mg) or placebo (PLC). Three hours after the gel administration the participants will intranasally self-administer 24 IU of OXT or PLC under supervision and 30 min later a fear extinction task will commence, followed by an emotion recognition paradigm. A fear extinction recall task (identical with the fear conditioning task except for the electric shocks) will be conducted in the third session (with a 24-hours break between the second and the third session).

In Study 2, participants will be randomly assigned to four different treatment conditions (1. OXT + PLC gel; 2. OXT + estradiol gel; 3. PLC + PLC gel; 4. PLC + estradiol gel) after the screening session. The timing of the drug administration and blood sample collection will be identical to that of the second session of Study 1. The fMRI paradigms (resting state, emotional face matching and emotional memory) will start 30 minutes after nasal spray administration. Three days after the scanning, participants will be tested with a surprise recognition task, which includes pictures shown in the scanner and distractors.

Eligibility Criteria:
Inclusion Criteria:

* right handed
* healthy male \& female volunteers
* women will be tested in their follicular phase (Day 0-5)

Exclusion Criteria:

* smoking
* pregnancy
* hormonal contraception
* current psychiatric illness
* current psychiatric medication or psychotherapy
* Study 2: MRI contraindication (e.g. metal in body, claustrophobia)
A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma

The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.

The drug being tested is called ciclesonide. This study looked at the safety and efficacy of inhaled ciclesonide in children with asthma. The study enrolled 1080 patients.

Participants were randomly assigned to 1 of 4 treatment groups which were undisclosed to the patient and study doctor during the study:• Ciclesonide 40 µg, 80 µg or 160 µg • Placebo- this is similar to study drug but has no active ingredient. Ciclesonide was inhaled via a metered-dose inhaler (MDI with HFA-134a propellant), with or without spacer, once daily in the evening throughout the study. All participants were asked to document daily AM and PM peak expiratory flow (PEF), daytime and nighttime asthma symptom scores and number of puffs of rescue medicine in an electronic diary. This multi-centre trial was conducted worldwide. The overall time to participate in this study was 20 weeks. Participants made multiple visits to the clinic plus a final visit 30 days after the last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Main Inclusion Criteria:

* History of asthma for at least 6 months
* Ability to show optimal use of MDI, including inhalation technique
* Lung function and reversibility within specified limits

Main Exclusion Criteria:

* Concomitant severe diseases
* Diseases which are contraindications for the use of inhaled steroids
* Two or more inpatient hospitalizations for asthma within the last year
* Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
* Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6 weeks)
* Beginning of or change in immunotherapy within the last 6 months prior to inclusion
* Inability to follow the procedures of the study
Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Chronic Neck Pain

Chronic neck pain causes errors in joint position. There are studies in the literature suggesting that the application of instrument-assisted soft tissue mobilization improves the sense of joint position. There are no studies that acutely examine this practice on joint position sense and pain in the cervical region. As a result of our study, we will investigate the effects of instrument-assisted soft tissue mobilization in a single session on perception of pain and joint position.


Eligibility Criteria:
Inclusion Criteria:

* • Being diagnosed with chronic neck pain,

  * To be in the age range of 18-65.

Exclusion Criteria:

* • Those taking any analgesic medication

  * Those with acute injury or infection,
  * Those with open wounds, Osteoporosis,
  * Broken,
  * Hematoma, Those with acute cardiac, liver and kidney problems,
  * Those with connective tissue disease, Rheumatoid arthritis, osteoarthritis, Cancer,
  * Those with circulation problems,
  * Those with peripheral vascular disease, Epilepsy, Surgery history in the cervical area
Repeated Bone Marrow Transplantation in Treating Women With Advanced Breast Cancer

RATIONALE: Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of repeated use of high-dose chemotherapy plus bone marrow transplantation and samarium 153 in treating women who have stage IV breast cancer.

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of samarium 153 used sequentially with autologous bone marrow transplantation for metastatic breast cancer. II. Determine the response rate, median duration of response, and overall survival of patients who respond to induction therapy followed by 2 cycles of high dose chemotherapy and stem cell support.

OUTLINE: This is a dose escalation study. Patients are first treated with salvage chemotherapy for no more than 4 cycles. At least a partial remission must be achieved. Peripheral blood stem cells (PBSC) are collected following the administration of filgrastim (granulocyte colony-stimulating factor; G-CSF). After recovery from the prior chemotherapy, high dose chemotherapy begins. Paclitaxel is administered as a 24 hour infusion on day -7. Melphalan IV is administered over 1 hour on days -6 and -5. PBSC are infused on day 0. A second regimen of high dose chemotherapy begins after at least 42 days posttransplant and as long as at least partial remission occurs after previous chemotherapy. Samarium 153 is administered on day -14. Cohorts of 3 patients each are treated at each dose level until the maximum tolerated dose is reached (defined as dose at which the dose limiting toxicity occurs in 3 or more of 6 patients). Cyclophosphamide, thiotepa, and carboplatin are infused over 24 hours on days -7 through -4. PBSC are infused on day 0 followed by G-CSF IV. The phase II dose of samarium 153 is one dose level below the MTD determined in the Phase I portion of this study. Patients are followed until death.

PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic breast cancer Adequate peripheral blood stem cells harvested and stored

PATIENT CHARACTERISTICS: Age: 21-65 Sex: Female Performance status: 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Ejection fraction of at least 50% No symptomatic coronary artery disease Pulmonary: FEV1 and DLCO greater than 50% of predicted Other: Not pregnant Not HIV positive Not hepatitis B surface antigen positive No uncontrolled infection No other prior malignancy within 5 years except: Curatively treated in situ adenocarcinoma of the cervix Curatively treated nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Recovered from toxic effects of prior therapy Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for metastatic disease Surgery: Not specified
A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate (50 milligrams\[mg\], 100mg, and 200mg taken daily) compared with placebo in the prevention of migraine.

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the effectiveness and safety of three different doses of topiramate (50mg, 100mg, and 200mg daily) in migraine prophylaxis. The study consists of five phases: baseline (determination of whether patients meet the eligibility criteria and tapering of any migraine medication patients are already taking); initial titration and double-blind phase (8 weeks) which begins with 25 mg/daily increasing to the assigned (50, 100, 200 mg/day topiramate); followed by a maintenance period at the target dose (18 weeks); tapering transition phase (up to 7 weeks); and open-label extension up to 6 months (to a maximum topiramate dose of 1600 mg/day); doses are adjusted to maximize effectiveness and minimize side effects. The primary study hypothesis is that one or more of the three doses of topiramate (50, 100, 200 mg/day) will be superior to placebo in the prophylaxis of migraine based on the change in monthly (28 day) migraine period rate from the prospective baseline period to the double-blind phase and that topiramate treatment is well tolerated. During the titration period (8 weeks), doses are increased to target dose of daily topiramate (50 milligrams\[mg\], 100, or 200mg) or placebo, taken twice daily by mouth. Doses are continued for 18 weeks, adjusted over 7 weeks, and continued for up to 6 months during the Open-Label Extension.

Eligibility Criteria:
Inclusion Criteria:

* Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 6 months prior to the study
* Between 3 to 12 migraine periods and no greater than 15 headache days (migraine and non-migraine) per month during the Baseline Phase
* No clinically significant abnormalities on neurological exams, electrocardiogram (ECG) or clinical laboratory test results at baseline
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

* Patients with headaches other than migraine
* Patients with episodic tension or sinus headaches
* Onset of migraine after age of 50 years
* Patients who have failed more than two adequate regimens for migraine prophylaxis
* Patients who overuse pain medications or certain other medications
Pilot Study of APD209 in Cancer Cachexia

Primary Objective:

To assess the efficacy of APD209 in adult patients with active cachexia associated with advanced malignancy and not caused by simple starvation.

Secondary Objective:

To assess the safety of APD209 in patients with advanced malignancy and active cachexia.


Eligibility Criteria:
Inclusion Criteria:

* Involuntary loss of weight of \>= 2% in 2 months or \>= 5% in 6 months, and ongoing in recent weeks, without (or with successfully treated) secondary causes of impaired oral nutritional intake (simple starvation).
A Study of the Pharmacokinetics of ASC09F in Healthy Subjects

The objective of this study is to evaluate the pharmacokinetic parameters of ASC09F in healthy subjects after multiple oral dosing.

This study will evaluate the safety and the pharmacokinetics of ASC09F tablets in healthy volunteers. Subjects will receive 7 days multiple oral doses of ASC09F tablets.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18-45 (including boundary value), half men and half women. 2. Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).

  3. According to the medical history, physical examination, vital signs, laboratory examination and 12 lead electrocardiogram (ECG) examination, the general health condition is good, and there is no clinically significant abnormality in each index.

  4. Unplanned pregnancy within half a year and willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration.

  5. The pregnancy test of female subjects during the screening period is negative.

  6. Those who voluntarily sign the informed consent.

Exclusion Criteria:

* 1. Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody were tested positive.

  2. People who have taken special diet (including carambola, dragon fruit, mango, grapefruit, orange, etc.) or drunk alcohol, or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 2 weeks before taking the study drug.

  3. Heavy smokers (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine;Smoking daily ≥ 5 sticks) and no smoking or alcohol prohibition during the study period.

  4. Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.

  5. Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.

  6. Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.

  7. Alcoholic or nonalcoholic fatty liver disease. 8. In addition to the above, the researchers judge that the participants are not suitable to participate in this clinical trial.
Mechanisms Underlying Impaired Diabetic Wound Healing

The overall aim of this research is to utilize wound derived inflammatory cells from diabetic versus non diabetic human chronic wounds to understand mechanisms that are responsible for disregulated inflammation in individuals with diabetes. Biology of normal (peripheral blood derived cells) versus wound derived cells will also be studied.

Specific aims:

1. To study biology of wound derived inflammatory cells and fluid from diabetic versus non diabetic wounds.
2. To characterize mechanisms that are responsible for dysregulated wound inflammatory cell function in individuals with diabetes.
3. To characterize differences in the biology of normal peripheral blood derived cells versus wound derived cells.

The long-term goal of this study is to determine the molecular mechanisms underlying impaired wound healing in diabetics.

Eligibility Criteria:
Inclusion Criteria:

* Ages 21-80
* Chronic Wound (present \>4 weeks)
* Diabetic \& Non-diabetic
* Adult surgical wounds

Exclusion Criteria:

* Inability to consent
* Pregnant women
* Therapeutically immunocompromised
* Individuals defined in 45 CFR 46 Subparts B,C, and D, nor from any other population considered vulnerable 2.9
Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants

The purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation \[32-35 weeks post-menstrual age (PMA)\] premature infants.

1. To assess the feasibility of measuring body fat deposition by ADP in medically stable late gestation (32-35 weeks), premature infants during a period of rapid postnatal growth.
2. To test the relationship between %BF by ADP to %BF by DXA, as well as characterize the relationship between these fat measures with bone measures by quantitative ultrasound and serum levels of insulin, IGF-1, IGF binding proteins, adiponectin and leptin.
3. To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP measurements.
4. Compare growth, body composition and bone strength between infants born preterm to infants born full term.

Eligibility Criteria:
Inclusion Criteria:

* Infants born between 32 4/7 and 35 3/7 weeks gestation or 37 4/7 and 42 3/7 weeks gestation, by physical exam at birth
* Birth weight between the 5th and 95th percentile corrected for gestational age

Exclusion Criteria:

* Chromosomal abnormalities
* Major congenital anomalies
* Major surgery
* Severe CNS injury
* Inborn errors of metabolism
* Assisted ventilation
* Inability to start enteral feeds by 96 hours of age
Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution for Colonoscopy

To evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) between the first and last dose of laxative is not inferior to a long time interval (10-12 hours) in bowel preparation quality.

The split-dose bowel preparation is recommended by multiple guidelines and widely used worldwide for improved bowel preparation quality, higher detection rate of colorectal lesions, and better tolerance. The effect of the time interval between the last dose of laxative and the colonoscopy on the quality of bowel preparation has been well studied, but the impact of the time interval between the first and last dose of laxative on the bowel preparation quality deserve to be explored. Oral sulfate solution administered in a short time interval can reduce sleep disturbance and hunger and is more flexible and convenient. This study aims to evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) is not inferior to a long time interval (10-12 hours) on bowel preparation quality.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate and sign informed consent;
* Subjects who require screening, surveillance, and diagnostic colonoscopy;
* Subjects who take the oral sulfate solution for bowel preparation.

Exclusion Criteria:

* Subjects with serious cardiac and cerebrovascular diseases, bronchial and lung diseases, suffering from metabolic disease or endocrine disease, abnormal blood clotting mechanism, malignant tumor, electrolyte abnormalities, epilepsy, renal or liver dysfunction;
* Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration.
* Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding;
* Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon.
* Subjects who had previously undergone colorectal resection.
* Subjects with constipation or suspected severe gastric motility disorder;
* Women with positive pregnancy tests or pregnancy plans, and women in lactation;
* Subjects who have participated in any other clinical trials within the last 3 months;
* Subjects with any other conditions that the investigator considered inappropriate for inclusion.
MED-EL Remote Care Multi-Center Feasibility Study

MED-EL Remote Care is a way for MED-EL cochlear implant users to check their hearing and cochlear implant device from any location, without the need for a scheduled, in-person appointment with their audiologist. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.

This prospective multicenter study will include MED-EL cochlear implant users from the US and Canada. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.

Eligibility Criteria:
Inclusion Criteria:

* Implanted with at least one MED-EL cochlear implant
* ≥ 2 weeks since activation of the cochlear implant
* Availability of existing aided Pediatric/AZ Bio (quiet and/or noise) and CNC word scores, or the ability to complete these at baseline
* Utilizing a compatible audio processor in the SONNET or RONDO product lines
* Ability to complete app-based hearing assessments
* Commitment to comply with all study procedures for the duration of the study
* Access to the internet via a smartphone that meets the following requirements:
* Android or iOS operating systems
* A smartphone supporting Bluetooth® 4.2 or higher
* A minimum of 200 MB free storage space

Exclusion Criteria:

* Inability or unwillingness to perform the requirements of the clinical investigation
* Unrealistic expectations regarding the possible benefits, risks, and limitations of remote cochlear implant care
* Inability of the subject or caregiver to demonstrate basic skills for operating a smartphone, computer, or app-based tasks after training by the investigator