cyrilzakka/clinical-trials huggingface dataset:
Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.

Many treatment cases proved that autologous chondrocyte transplantation is a useful treatment method for patients with damaged articular cartilage.

This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron(autologous chondrocyte) transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.

Eligibility Criteria:
* Inclusion Criteria:

  1. Adult males and females aged between 15 and 65
  2. Patients with a partial cartilaginous defect in the ankle joint confirmed arthroscopically or visually
  3. Patients with misalignment between tibia and talus of the ankle joint, lateral ankle instability, and a bony defect in the cartilaginous defect or who had a correction simultaneously or in advance
  4. Patients whose surrounding cartilage is normal
  5. Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial
* Exclusion Criteria:

  1. Patients hypersensitive to bovine protein
  2. Patients hypersensitive to antibiotics like gentamicin
  3. Patients with inflammatory arthritis, such as rheumatoid arthritis and gouty arthritis
  4. Patients with arthritis associated with autoimmune diseases
  5. Patients who are pregnant, nursing a baby or likely to get pregnant
  6. Patients with other diseases including tumors except for cartilaginous defects of joints
  7. Patients with an anamnesis within the past two years, such as radiation treatment and chemotherapy
  8. Diabetics (however, patients who were normal in the blood glucose test and have no complication due to diabetes will be excluded if the doctor says Chondron can be administered to them)
  9. Patients with infections who are taking antibiotics and antimicrobial agents
  10. Patients who are treated with adrenal cortical hormones
  11. Patients whom the investigators find to be unfit for this clinical trial, such as mental patients
A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density

Up to 20 subjects will receive an injection with \[11C\]-UCB-J followed by a PET scan on Days 1 and 28

After assessing eligibility during a 4-week screening period, approximately 20 subjects will participate in the PET acquisition phase of the study. Drop-outs or unevaluable subjects will be replaced for a target sample size of 20 completed and evaluable subjects.

During the screening period, a 3D T1-weighted MRI must be acquired and reviewed for exclusion criteria and acquisition quality.

On the day of radioligand administration (Day 1), subjects will come to the study center for an ambulatory visit (Visit 1). After re-confirming eligibility, all subjects will receive an injection with \[11C\]-UCB-J followed by a PET scan.

Using an arterial line and manual sampling, blood samples will be collected up to 90 minutes after radioligand injection in order to quantify radioactivity concentration in whole blood and plasma as well as parent fraction over time.

Subjects will return to the clinic for one more ambulatory visit on Day 28 ± 3 (Visit 2). The same procedures will be performed as on Day 1.

PET scanning duration will be initially set to 90 minutes. After a minimum of 4 subjects have completed baseline and Day 28 scans, 90 minute and 60 minute scan data will be analyzed. Based on this analysis, and at the discretion of the investigator, it will be decided whether the remaining subjects will require 60 or 90 minute scans.

Adverse events will be recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

Group 1

* Healthy male or female age 55 - 75 years old, inclusive, at the time of informed consent.
* Mini-mental state examination (MMSE) greater than or equal to 27.

Group 2

* Adult males or females age 55 - 75 years old, inclusive, at the time of informed consent.
* Confirmed diagnosis of mild-to-moderate AD, defined as:

  1. National Institute on Aging - Alzheimer's Association (NIA-AA) "probable" diagnosis (see Appendix 2);
  2. MMSE 18-26.

Exclusion Criteria:

* History or current evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic (with the exception of AD in Group 2), psychiatric, renal, or other major disease, as determined by the Investigator.
NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)

Study 07-PIR-02 is a Phase 2 study designed to evaluate the safety and efficacy of NKTR-102 (PEG-irinotecan) for the treatment of patients with colorectal cancer (CRC). The study is comprised of two sequential components - Phase 2a and Phase 2b. The Phase 2a portion is an open-label, dose-finding trial in multiple solid tumor types that are refractory to standard curative or palliative therapies. The primary endpoint of the Phase 2a is to establish the /recommended Phase 2 Dose (RPTD) of NKTR-102 by measuring the frequency of Dose Limiting Toxicity (DLT). The Phase 2b portion is an open-label, randomized, two-arm study in patients with second-line metastatic colorectal cancer and study participants will be randomized (1:1) to receive either NKTR-102 and cetuximab or irinotecan and cetuximab. The primary endpoint of the Phase 2b portion of the trial is progression-free survival. Secondary endpoints for both the Phase 2a and 2b portion include response rate, response duration, overall survival, standard pharmacokinetics, and incidence of toxicities, including diarrhea and neutropenia.

The Phase 2a portion of this study is completed. The following entries reflect the Phase 2a portion of this study only. The Phase 2b portion of the study was not enrolled. Based on emerging data regarding the corresponding low efficacy of cetuximab in patients with KRAS mutations, as well as revised NKTR-102 clinical development plans, the Phase 2b portion of the study was not completed.

Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant, non-lactating female patients with an ECOG performance score \<3 who have any type of solid tumor refractory to standard therapy and who have adequate bone marrow and organ function at screening.

Exclusion Criteria:

* Patients must not have used any CYP3A4 inducers or inhibitors with 2 weeks prior to the first day of study drug treatment.
Postural Effects of Being Rotated in a Whole Body Gyroscope

Subjects will be secured and rotated in a whole body gyroscope, similar to a flight trainer for astronauts. The rotations will be in many directions and the speed will be at 90 deg/sec. The effects of this rotation on the ability to stand upright will be measured.

Computerized dynamic posturography (CDP) testing will be obtained after practice sessions on all subjects using a CAPS Pro system (Vestibular Technologies, Cheyenne WY, USA). All tests will be conducted with the subject standing on a perturbing foam cushion. Six different conditions will be tested in sequence without the subjects stepping away from the foam/platform in order to assess if the center of sway position changed with the changing test conditions: (1) Eyes Open Head Neutral, (2) Eyes Closed Head Neutral, (3) Eyes Closed Head Right, (4) Eyes Closed Head Left, (5) Eyes Closed Head Flexed, (6) Eyes Closed Head Extended. Subjects will be continuously rotated in a computer-controlled multi-axis chair (Gyrostim by UltraThera Technologies, Inc.) in combinations of whole body Pitch and Yaw simultaneously over a 40 second profile at 90 deg/sec (15 RPM). The acceleration rates to 90 degrees per second as well as deceleration rates will be linear and occur in 1 second. We will utilize rotations that will represent all combinations of pitch and yaw with Pitch direction changing two times and Yaw direction four times (Backward Pitch -20 seconds with right Yaw-10 seconds to left Yaw-10 seconds, to Forward Pitch- 20 seconds with right Yaw-10 seconds to left Yaw 10 seconds). Post rotational CDP testing will be compared to the Pre Rotational CDP,

Eligibility Criteria:
Inclusion Criteria:

* Normal Healthy Adults without a history of vertigo or dizziness

Exclusion Criteria:

* History of dizziness or vertigo
The Relaxation vs. Retreat Study

The purpose of this research study is to examine whether a short term meditation intervention can improve health, mood, and biological markers of cellular stress and aging in novice and experienced meditators compared to controls.

There are 3 parts to this research study, Part A, B, and C.

In Part A, participants complete a brief online questionnaire sent to them via email by the study coordinator.

During Part B of the study, participants stay at La Costa Resort in Carlsbad, CA for 6 nights and participate in a meditation retreat being held at the resort, or stay at the resort without participating in the retreat. During their stay, participants attend two in-person research assessments throughout the week. Assessments will be 4 days (96 hours) apart for all participants and will include a fasting blood draw, body measurements, and self-report questionnaires.

Part C of the study includes a brief online questionnaire that is completed 1 month after participants leave La Costa Resort.

This study includes 3 groups: a group of "novice meditators" from the greater San Diego Region that are randomized into either the 1) Relaxation (Control) group or 2) Retreat group. The third group is comprised of self-selected "experienced meditators" who are already enrolled in the retreat. In total, 99 participants were recruited for this study.

The Retreat group stays at La Costa Resort and attends a 6 day meditation retreat intervention as well as completes all research study assessments and questionnaires.

The Relaxation (Control) group stays at La Costa Resort for 6 nights, but does not attend the meditation retreat. They attend once daily lectures on science topics and complete all research study assessments and questionnaires.

The Experienced Retreat group participants have an ongoing meditation practice and have enrolled themselves in the April 2013 meditation retreat. All of the Experienced meditators attend the meditation retreat and complete all research study assessments and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Women
* Age 30-60
* "Novice Meditator" (meditates for 30 minutes per week or less) or "Experienced Meditator" (meditates at 40 or more per week and for more than 6 months, and are self-selected/enrolled in the retreat)

Exclusion Criteria:

* Current or history of a major medical condition (such as cancer, heart disease, autoimmune disease, diabetes)
* Smokers (have not smoked regularly for the past 6 months)
* Currently taking antidepressants
* Post Traumatic Stress Disorder
* Currently taking Hormone Replacement Therapy or birth control pills
Comparison of Microwave Ablation With Cryoablation for Breast Tumor

The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and cryoablation of benign and malignant breast lesion under ultrasound (US) guidance.

A total of more than 200 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in two centers of China will be recruited in this study and underwent US-guided percutaneous MWA and cryoablation treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be compared and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* (a) the breast tumor obtained the pathological diagnosis by using core-needle biopsy; (b) for the benign lesion, continually increasing during a half year followup,with the symptoms of local pain, discomfortable or compression considered probably relating to the mass of breast; the patient with evidently psychological pressure due to the occurrence of the BBL despite clearly benignancy on imaging; (c) for the malignant lesion, with the tumor size smaller than 2cm and without other metastasis.

Exclusion Criteria:

* (a) the patients who were pregnant or breast-feeding; (b) the patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction; (c) the patients during menstrual period; (d) the patients referring to other therapies including surgical excision and vacuum-assisted biopsy.
Primary Lesion Treatment for Bone Metastases

This study will carry out a prospective cohort study to study the effect of different primary leison treatment modes on disease control, quality of life, economic cost and survival period of patients with bone metastases from breast cancer and lung cancer by giving radiotherapy or palliative surgery or not giving local treatment for the primary lesion in patients with bone metastases from breast cancer or lung cancer


Eligibility Criteria:
Inclusion Criteria:

1. HR positive breast cancer patients with bone metastasis or Non-small-cell lung cancer patients with bone metastasis；
2. Aged over 18;
3. ECOG：0-1；
4. Patients who benefit clinically(CR+PR) after 6 months of treatment.

Exclusion Criteria:

1. The expected life span is less than 3 months;
2. Have serious cardiovascular and cerebrovascular diseases, blood coagulation dysfunction, and cannot tolerate surgery;
3. Allergies to narcotic drugs;
4. The patient refused the treatment decision of the integrated team.
Collection of Clinical Specimens From Volunteers for Assay Development

This study will analyze gene expression data from various biological specimens collected from voluntary participants.

Primary objective is the collection of specimens from volunteers for the development and validation of HostDx tests. The study does only encompass specimen collection - Therefore, no traditional endpoint is defined but rather the successful collection of clinical specimens is defined as the endpoint.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* Able to provide informed consent

Exclusion Criteria:

* Known pregnancy
* Inability to understand instructions and comply with study related procedures
Effect of Clomiphene Citrate on Uterine Blood Fow in Women With Unexplained Delayed Conception

In a prospective observational study at a university teaching hospital, blood flow indices and serum hormone levels were compared between spontaneous and stimulated cycles in the same group of 50 patients with unexplained delayed conception.

In a prospective observational study at a university teaching hospital, the mid-luteal (peri-implantation) endometrial thickness and volume, uterine artery pulsatility index (PI) and resistance index (RI), endometrial and subendometrial vascularization index, flow index, and vascularization flow index, and serum estradiol and progesterone levels were compared between spontaneous and clomiphene citrate stimulated cycles in the same group of 50 patients with unexplained infertility.

Eligibility Criteria:
Inclusion Criteria:

* Unexplained infertility
* Body mass index less than 30
* Regular menstruation
* Normal pelvic examination and ultrasonography

Exclusion Criteria:

* History of pelvic operations including cesarean section
* History of pelvic inflammatory disease
* Endometriosis
* Pelvic pathology including uterine fibroids
* General disease or medication that could potentially affect pelvic blood flow
* Smoking
Fourier Transformed Infrared Spectroscopy in Macular Surgery

Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT).

The aim of the study is to examine ERM and internal limiting membranes (ILM) exzised during routine macular surgery with fourier transformed infrared spectroscopy (FTIR) and compare results to optic coherence tomography (OCT) findings.

Purpose of the present study is to analyse components of ERM and ILM, giving hints for the origin of cells producing ERM. In contrast to electron microscopy, FTIR spectroscopy does not need any chemical fixation of the membranes and therefore structure of components of ERM and ILM are not changed by fixation.

In total, 20 eyes with idiopathic ERM, 10 eyes with lamellar macular hole, 10 eyes with full thickness macular hole and 10 eyes with diabetic ERM will be examined. To our knowledge there are no previous reports about FTIR spectroscopy of ERM and ILM, therefore the study will be performed as an exploratory pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic ERM, lamellar macular holes, full thickness macular holes, diabetic ERM and the indication for surgery (visual symptoms)
* Age 21 and older
* written informed consent for surgery and participation in the study prior to surgery

Exclusion Criteria: - Macular edema due to other reasons than ERM

* Hereditary macular disorders
* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir

Bioequivalence study of two formulations containing a fixed dose combination of 600 mg Efavirenz, 200 mg Emtricitabine and 300 mg Tenofovir Disproxyl Fumarate in coated tablets under a single-dose, two-way crossover design.


Eligibility Criteria:
Inclusion Criteria:

Male subjects between 18 and 55 years. Subjects with body mass index (BMI) between 19 and 27 kg / m². Subjects whose complementary tests (ECG, blood and urine) are within normal and / or clinically insignificant according to the judgment of the investigator.

Subjects with systolic blood pressure between 110 mmHg and 139 mmHg; diastolic pressure between 70 mmHg and 89 mmHg; heart rate between 50 and 90 beats per minute.

Subjects who signed informed consent.

Exclusion Criteria:

Background of clinically significant allergies (except untreated asymptomatic seasonal allergies), drug hypersensitivity and / or hypersensitivity to any component of the formulations studied.

Drop of more than 20 mmHg in systolic blood pressure or more than 10 mmHg diastolic pressure in the first 3 minutes of postural change.

Active smoker more than 10 cigarettes / day. Pregnant or lactating women. Current clinical evidence of severe digestive disorders, surgery of the digestive tract (except appendectomy).

Current clinical evidence of kidney disease. Current evidence of liver disorders Current clinical evidence of respiratory and heart diseases. The presence of diabetes mellitus, thyroid dysfunction or other endocrine disorder.

Evidence of gastroduodenal disease. Current presence of any malignancy. History of abuse or addiction to drugs or alcohol during the past three years. Participation in a clinical trial within the last three months. Use of any drug within fourteen days before the start of the study. Subject donated or suffered blood loss during the last twelve weeks before the start of the study, or intends to donate blood within three months of the completion of the study.

Excessive drinking of tea, cocoa, mate, coffee and / or beverages containing caffeine (\> 5 cups / day) or wine (\> 0.5 L / day) or alcohol (\> 50 ml / day).

ECG abnormalities. Positive serology for HIV, hepatitis B or hepatitis C.
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis

The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.

This is a randomized, double-blind, parallel-group comparative study to demonstrate the noninferiority of TAU-284 to ketotifen fumarate in pediatric patients with atopic dermatitis, as assessed by the primary endpoint of the change from baseline in pruritus score after 2-week treatment with TAU-284 (20 mg/day) or ketotifen fumarate dry syrup (2 g/day); and to investigate the safety, and plasma concentrations of TAU-284.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 7 and 15 years
* Patients giving assent and whose legal guardian giving informed consent
* Outpatients
* Patients diagnosed as atopic dermatitis
* Patients who require the treatment with topical corticosteroid on areas other than face, head and neck
* Patients whose diaries can be properly maintained
* Patients who have 2 grades or more pruritus score

Exclusion Criteria:

* Patients with bronchial asthma who require concomitant use of the corticosteroid
* Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy
* Patients with current or previous history of drug hypersensitivity
* Patients who have been treated with Bepotastine besilate in the past
* Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied
* Patients who have spastic disease such as epilepsy
* Patients who concurrently have renal function abnormalities that may cause safety problems
* Patients who do not give consent to use birth control
* Pregnant patients, at risk of pregnancy or breastfeeding
* Patients who had participated in any clinical trial in the last 12 weeks
Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression

The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.


Eligibility Criteria:
Inclusion Criteria:

* normal subjects who are age 18-65
* generally healthy
* non-childbearing potential females or those using birth control

Exclusion Criteria:

* history of significant GI disease
* any significant medical illness
* history of hypersensitivity, allergy or intolerance to omeprazole, lansoprazole or other proton pump inhibitors
* currently using GI medications
* GI disorder or surgery leading to impaired drug absorption