cyrilzakka/clinical-trials huggingface dataset:
Assess Safety, Tolerability and Pharmacokinetic (PK) of AZD1704 in Healthy Japanese Male and Non-Fertile Female Volunteers

The primary objective of this study is to investigate the safety and tolerability of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers by assessment of adverse events (AEs), vital signs (supine and standing blood pressure, pulse rate, respiratory rate and body temperature), safety laboratory variables and 12 lead electrocardiography (ECG). The secondary objectives of the study are: to investigate the subjective CNS effects of orally administered AZD1704 in healthy Japanese male and non-fertile female volunteers on a psychometric rating scale by assessment of specific adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale (VAMS) and to investigate the pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese males and non-fertile females, defined as first generation Japanese (both parents and grandparents are of Japanese origin, the subject is born in Japan and has not been living outside of Japan for more than 5 years) aged 20-45 years .
* Clinical normal physical findings
* BMI 19 - 27, weight 50 - 95 kg

Exclusion Criteria:

* History of somatic disease/condition or ongoing psychiatric disease/condition that may interfere with the objectives of the study.
* History of psychotic disorder among first-degree relatives.
* History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use.
* Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before administration of study drug.
Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic Targets

Fibrosis is a dynamic process resulting from the balance of fibrogenesis and fibrolysis, mainly secondary to chronic necro-inflammation related to regular alcohol consumption, metabolic syndrome (NASH) or viral hepatitis. The liver has the property of allowing the reversion of fibrosis / cirrhosis when the necrotic-inflammatory activity is controlled. The balance between fibrosis / fibrolysis and its inhibition depends on many pathways and the hypothesis of the efficacy of a single treatment remains uncertain. Molecular factors in the progression of liver fibrosis should be determined. It is necessary to control the liver fibrosis and thus reduce the risk of carcinoma in this population. The anti-fibrotic drugs are being developed, but so far only alpha-tocopherol and obeticholic acid have been shown to have a significant anti-fibrotic effect in humans. Several new drugs are currently being evaluated in ongoing Phase 2 and 3 randomized clinical trials, but most of them have intrinsic limitations: (i) they take a long time for evaluation (\> 3 years), ( ii) they generally require an histopathological evaluation by serial liver biopsies that are invasive and unpopular with patients who are aware of noninvasive tests for fibrosis assessment and (iii) treatment is often a single treatment versus a placebo group with the uncertainty that at 1 or 3 years, serial liver biopsies results are convincing.

The study will be performed in 30 patients. Patients will be enrolled in two investigators sites (Cochin Hospital, Pitie-Salpetriere Hospital, France) where the patient selection will be conducted during a Multidisciplinary Collaborative Meeting.

The patients will be enrolled after collecting their informed consent. As soon as the patient is included, arrangements will be made for the organization of the liver resection according to the usual procedure of the hospital department.

The biological samples for the research (blood and liver) will be taken at the time of the surgery and sent to the Research Unit (Institut Pasteur) where immunological analyses will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Patients with primary liver disease or liver metastases
* Patients undergoing liver resection

Exclusion Criteria:

* Presence of Human Immunodeficiency Virus (HIV) infection
* Presence of Human T Leukemia Virus (HTLV) infection
* Taking immunosuppressive drugs in the 6 months prior to surgery
* A person deprived of liberty by judicial or administrative decision
Gemcitabine and Capecitabine in Treating Patients With Advanced and/or Inoperable Cholangiocarcinoma or Carcinoma of the Gallbladder

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced and/or inoperable cholangiocarcinoma or carcinoma (cancer) of the gallbladder.

OBJECTIVES:

Primary

* Determine the response rate in patients with advanced and/or inoperable cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and capecitabine.

Secondary

* Determine time to disease progression and overall survival of patients treated with this regimen.
* Determine quality of life of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at weeks 3, 6, 9, and 12.

Patients are followed monthly.

PROJECTED ACCRUAL: A total of 9-17 patients will be accrued for this study within 1.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed cholangiocarcinoma or carcinoma of the gallbladder

  * Advanced and/or inoperable disease
* Measurable disease

  * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* No known brain metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2 OR
* Karnofsky 60-100%

Life expectancy

* More than 2 months

Hematopoietic

* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin \< 3 mg/dL

Renal

* Creatinine ≤ 1.6 mg/dL

Cardiovascular

* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other concurrent uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* More than 4 weeks since prior chemotherapy and recovered
* No more than 1 prior chemoembolization OR chemoradiotherapy regimen for locally advanced biliary tract cancer
* No other prior chemotherapy (except adjuvant therapy)

Endocrine therapy

* Not specified

Radiotherapy

* See Chemotherapy
* More than 4 weeks since prior radiotherapy and recovered

Surgery

* Not specified

Other

* No other concurrent investigational agents
* No other concurrent anticancer agents or therapies
The Effect of Physiotherapy on Lower Extremity Function and Gait in Children with Isolated Gastrocnemius Muscle Tightness

Since the gastrocnemius muscle crosses both joints, the joint kinematics of the ankle are affected by knee flexion. According to the Kendall \& McCreary assessment of normal joint motion angles, the generally accepted normal range of motion for ankle dorsiflexion is 20° when the knee joint is in extension and can approach 30° when the knee joint is flexed due to relaxation of the gastrocnemius. In the mid-stance phase of gait, it is observed that the ankle joint allows 8-10° dorsi flexion movement.

In this study, a minimum 13° increase in dorsiflexion with knee flexion compared to dorsiflexion with knee extension will be considered as isolated gastrocnemius muscle tightness. Isolated gastrocnemius muscle tightness has been associated with many biomechanical changes such as pes planus, talar equinus, hindfoot pronation and symptoms such as plantar fasciitis, leg pain, metatarsalgia, achilles tendinopathy by compensatory effects on the lower extremity and foot during gait. The association of increased hindfoot pronation with isolated gastrocnemius tightness has been shown in many studies. Regardless of the etiology of pronation of the hindfoot, there will be adaptive isolated gastrocnemius tightness with talar plantar flexion. Isolated gastrocnemius tightness, which causes plantar flexion in the ankle joint and pronation in the subtalar joint, also prevents the distribution of the load to the base of the foot within normal limits during weight bearing. However, no study investigating the effect of physiotherapy program on function and gait has been encountered. The aim of this study was to investigate the effect of a physiotherapy program on lower extremity function and gait in children with isolated gastrocnemius muscle tightness.


Eligibility Criteria:
Inclusion Criteria:

* Presence of bilateral pes planovalgus due to the isolated gastrocneius tightness
* Being the ages between 4-10 years old
* Having body mass index between within normal limits

Exclusion Criteria:

* Presence of high femoral anteversion (Craig test \> 30 degrees) and/or internal tibial torsion and/or metatursus adductus
* Having of leg length discrepancy
* Accompanying any neurological, rheumatologic, musculoskeletal, metabolic and connective tissue disease
* Presence of pain associated with the vertebral column and lower extremities
* Presence of any lower extremity and/or vertebral column deformity or history of surgery
* Cognitive, mental, serious psychiatric illness
* Participation in any exercise program and/or sportive activity in the last six months
The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora

The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.

Epiphora is an overflow of tears,usually caused by insufficient drainage of the tear film from the eye.The most common cause is a blockage of the lacrimal ducts located next to the nose, but the condition may also result from the excessive production of tears. Epiphora is a symptom rather than a disease and may be caused by a variety of conditions.

30 subjects will be recruited for this study, informed consent will be taken from the willing subjects. Complete ophthalmic evaluation would be performed including visual acuity. Diagnosis would be made on history of epiphora, regurgitation test, lids examination, nasal examination, probing and syringing. Standard procedure of Dacryocystorhinostomy (DCR) would be adopted in all cases with lacrimal intubation.

Syringing will be done on first follow up visit and skin sutures will also be removed. Tightness and mobility of the silicone tube will be checked. The tube is kept in place for 3-6 months according to need and then finally removed. The patency of lacrimal passage will be investigated by irrigation. A successful outcome will be defined as resolution of symptoms like epiphora and discharge and a patent lacrimal system on irrigation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects having epiphora
* Canalicular blockade ascertained with probing
* Chronic dacryocystitis
* Mucocele

Exclusion Criteria:

* Absent puncta
* Acute on chronic dacryocystitis
* Noticeable lid laxity
* Previous lacrimal surgery
* Patients younger than 15 years
* Suspicion of malignancy
* Post traumatic lids
* Bony deformity
Radiation Therapy in Treating Patients With Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy may be an effective treatment for prostate cancer.

PURPOSE: Phase I trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III prostate cancer.

OBJECTIVES: I. Determine the maximum tolerated dose of radiotherapy using 3-dimensional (3D) conformal techniques in patients with stage II or III adenocarcinoma of the prostate. II. Determine the morbidity of high-dose 3D conformal therapy in these patients.

OUTLINE: This is a dose escalation study. Patients undergo 3-dimensional conformal radiotherapy 4-5 days a week for at least 8 weeks. Cohorts of 20-40 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 10% of patients experience dose-limiting toxicity. Patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Locally advanced (T2c-T3) adenocarcinoma of the prostate including: Bulky tumors confined to prostate (stage II) Tumors extending beyond capsule (stage III) PSA no greater than 20 ng/mL No regional lymph node involvement (by CT scan or surgical sampling) No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No metallic pelvic prosthesis

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No prior radiotherapy (including pelvic irradiation) Surgery: No prior radical surgery for carcinoma of the prostate
Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)

A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of primary insomnia

Exclusion Criteria:

* Patients with an active psychiatric disorder other than primary insomnia
Percutaneous Endoscopic Gastrostomy in Hands of ORL-HN Surgeon

PEG tubes are commonly used to provide nutritional support to patients with head and neck cancer. PEG insertions are typically carried out by gastroenterologists, but also otorhinolaryngologist - head and neck surgeons perform the procedure in some countries. Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG tube insertions, and analyze the time gains and cost effectiveness achieved of the independency from other specialities.


Eligibility Criteria:
Inclusion Criteria:

* head and neck cancer as a underlying disease

Exclusion Criteria:

-
Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis

The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis (SPMS).

Subjects whose myelin reactive T-cell can be identified by EPA will are randomized and provide blood to manufacture Tcelna. Approximately 5 weeks after receipt of the subject's whole blood procurement, the subjects will receive either Tcelna or placebo and will complete baseline assessments and will receive study treatments at Weeks 0, 4, 8, 12, and 24 (Visits 3-7), totaling 5 doses in year one.

Approximately one month prior to the Week 52 visit a second blood procurement will be performed and the subject will receive the second series of treatments as received in the first year study schedule. Subjects will be evaluated for changes in disability and cognitive function every 3 months, and radiographic changes annually.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MS as defined by the modified McDonald criteria
* SPMS defined as relapsing-remitting disease with recent progression in MS-related neurological deficits
* EDSS score 3.0 - 6.0, inclusively
* Presence of myelin reactive T-cells

Exclusion Criteria:

* Diagnosed with primary progressive MS
* Treatment with beta-interferon, glatiramer acetate or dimethyl fumarate 30 days prior to screening
* Treatment with ACTH, any over-the-counter or prescription corticosteroids 60 days prior to screening
* Treatment with IVIG, plasmapheresis or cytopheresis 90 days prior to screening
* Treatment with mitoxantrone, teriflunomide, fingolimod, natalizumab, azathioprine, cyclosporine, methotrexate or mycophenolate mofetil 1 year prior to baseline
* Any prior treatment with cladribine, cyclophosphamide, total lymphoid irradiation, T cell or T cell receptor products, or any therapeutic monoclonal antibody, except natalizumab
* Previous treatment with any other MS investigational drug 1 year prior to screening
* All non-MS investigational drugs must have a minimum washout of 30 days prior to screening or 5 half-lives, whatever is the longest period of time.
* HIV or hepatitis infection
* History of cancer
* Any other significant medical condition that, in the opinion of the investigator, could cause CNS tissue damage or limit its repair.
Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia (The GOLD-Study)

Glucagon like Peptide -1 (GLP-1) receptor agonists are well known to stimulate glucose-induced insulin secretion and to reduce energy intake. Recent findings from animal and human studies suggest a role of GLP-1 in regulating water and salt homeostasis. GLP-1 has been shown to reduce fluid intake after an oral salt load or during a meal - pointing to a hypodipsic effect. The aim of this study is to elucidate whether these putative hypodipsic properties of GLP-1 might be of advantage in persons with an exaggerated thirst perception as is the case in patients with primary polydipsia.

GLP-1 analogues are currently used for the treatment of hyperglycaemia associated with type 2 diabetes mellitus and given his properties as a natural satiety hormone, the GLP-1 analogue liraglutide was recently approved by the FDA for weight management.

In studies related to the influence of GLP-1 and -analogues in controlling food intake a concomitant reduction of fluid consumption has been observed.

The investigators hypothesize that GLP-1 analogues not only modulate appetite and provide satiety but also reduce fluid intake and thirst sensation in humans - especially in those with excessive thirst perception (patients with primary polydipsia). In view of future therapeutic options for these patients we aim to investigate the influence of the long-acting GLP-1 analogue dulaglutide on fluid intake, thirst perception and quality of life in patients with primary polydipsia compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Polyuria of \> 50 ml/Kg/day
* Polydipsia of \> 3 liters/day

Exclusion Criteria:

* Known or probable central or nephrogenic Diabetes insipidus, expected from patient's history
* Polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia
* Pregnancy
* Previous treatment with GLP-1 agonists within the last 3 month
* History of pancreatitis
* Severe renal insufficiency (eGFR (CKD EPI) \<30 ml/min/1,73 m2)
* Cancer
Evaluating Changes in Spermatogram Following Bilateral Laparoscopic Inguinal Hernia Repair in Fertile Males

In this prospective open armed study we aim to see if bilateral hernia repair using a mesh alters the spermatogram (sperm count) or testicular volume.


Eligibility Criteria:
Inclusion Criteria:

* Males ages 18-40 years, undergoing bilateral laparoscopic hernia repair, who agree to have a sperm test both prior to and following surgery.

Exclusion Criteria:

* History of prostatic surgery, testicular surgery, azospermia on first spermatogram, single testis, patients after chemotherapy, patients receiving hormonal therapy, patients receiving alpha blockers for any indication, patients who are receiving or received oral antifungal therapy six months prior to surgery
A Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening

The purpose of this study is to evaluate and compare the effectiveness of active screening for SHD in asymptomatic outpatients referred for an ECG, using a combination of AI-ECG and FOCUS. Invites will be sent and participants enrolled electronically.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years of age)
* Echocardiogram is not clinically indicated

Exclusion Criteria:

* Prior history of congenital or acquired SHD, as defined by the following

  1. Aortic Stenosis:
  2. Heart Failure
  3. Left Ventricular Dysfunction
  4. Cardiac Amyloidosis
  5. Hypertrophic Cardiomyopathy (HCM)
  6. Rheumatic Heart Disease
  7. Congenital Heart Disease
* Recent (within last 12 months) echocardiogram
* Scheduled clinically indicated future echocardiogram
* Inability to provide informed consent to participate in the study
G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for Secondary Acute Myeloid Leukemia Undergoing Allo-HSCT

Allo-HSCT is the most effective way to cure sAML patients. At present, the best conditioning regimen for sAML patients undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in sAML patients undergoing allo-HSCT are evaluated.

Allo-HSCT is the most effective way to cure secondary acute myeloid leukemia evolving from MDS (sAML) patients. At present, the best conditioning regimen for sAML patients undergoing allo-HSCT remains in discussion. Our previous study has showed that G-CSF+DAC+BUCY conditioning regimen could reduce the relapse and improve the survival compared with BUCY conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (NRM). Several retrospective and prospective studies including ours have demonstrated that BF conditioning regimen has a lower NRM compared with BUCY conditioning regimen, while the relapse and survival are similar in patients undergoing BF and BUCY conditioning regimens. Based on the above, we design the prospective randomized controlled study to evaluate the safety and efficacy of G-CSF+DAC+ BUCY and G-CSF+DAC+BF conditioning regimens in sAML patients undergoing allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Had a diagnosis of sAML
* Age 18 to 65 years old
* ECOG performance status of 0-2
* HCT-CI of 0-2
* Were willing to undergo allo-HSCT

Exclusion Criteria:

* Therapy-related MDS
* Previous allo-HSCT
* Uncontrolled infections
* Liver or renal dysfunction
* Severe concomitant conditions not suitable for the trial
A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer

This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m\^2 or 825 mg/m\^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.


Eligibility Criteria:
Inclusion Criteria:

* women \>=18 years of age;
* \>=1 target lesion;
* locally advanced or metastatic breast cancer;
* demonstrated resistance to anthracycline;
* \>=2 regimens of chemotherapy for advanced/metastatic disease.

Exclusion Criteria:

* previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
* previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.