louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01635777: Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PKDL
Keywords: PKDL
miltefosine
Lead sponsor: AB Foundation
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2012-07-10
Enrollment: 37
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Miltefosine efficacy will be \>85%


Eligibility criteria: Inclusion Criteria:

* 12 years or older
* nodules and papules consistent with post kala-azar dermal leishmaniasis
* parasitological confirmation of Leishmania infection

Exclusion Criteria:

* platelet count \<100x 109/l,
* leukocyte count \<2.5 x 109/l ,
* hemoglobin \< 8.0 g/100 ml ,
* liver function tests \>3 times upper limit of normal range,
* bilirubin \>2 times upper limit of normal range,
* serum creatinine or blood urea nitrogen \>1.5 times upper limit of normal range);
* any non-compensated or uncontrolled condition,
* lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter;
* treatment with any anti-leishmanial drug within the previous 12 weeks.

Primary outcomes:
measure: Cure rate
timeFrame: 12 months after end of treatment
Secondary outcomes:
measure: adverse events
timeFrame: during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group
Other outcomes:
Locations:
city: Varanasi
country: India
facility: Institute of Medical Sciences, Banaras Hindu University,
Study officials:
References:
Clinical trial NCT05851677: RC48-ADC in Breast Cancer
Official title: Disitamab Vedotin (RC48-ADC) in Patients With Breast Cancer: a Real World Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast cancer patients with prior or current use of Disitamab vedotin (RC48-ADC)

Brief summary: To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) in patients with breast cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed breast cancer;
* Prior or current use of Disitamab vedotin (RC48-ADC);

Exclusion Criteria:

* Participating in clinical trials involving Disitamab vedotin (RC48-ADC) or not.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years)
Secondary outcomes:
measure: Adverse events
timeFrame: From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 1 year)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study officials:
affiliation: Renji Hospital,School of Medicine, Shanghai Jiaotong University
name: Wenjin Yin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02452177: Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease
Official title: Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease: Clinical Observation and Experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Disease
Keywords: parenteral nutrition associated liver disease
vitamin D
short bowel syndrome
farnesoid X receptor
cholestasis
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2015-05-22
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients who accept long-term parenteral nutrition tend to suffer from liver injury. The mechanism for this injury has two possible explanations. The first possible reason is intrinsic toxic effects of parenteral nutrition. The second is the basic pathological condition of intestinal failure which includes infection, bacterial translocation, etc. Cholestasis is the lethal presentation of this kind of liver disease. Farnesoid X receptor (FXR) is a member of ligand-activated nuclear receptor superfamily. FXR serves as a sensor for bile acids and promotes enterohepatic clearance of bile acids by controlling the expression of genes involved in their transport and metabolism. Considering the activation of vitamin D receptor (VDR) by vitamin D can induce FXR-related genes in the liver.The hypothesis of this study is that vitamin D plays a key role in the prevention and reversion of the liver via VDR and/or FXR signaling pathway. Using a mouse cholestasis model based on short bowel syndrome and parenteral nutrition, the researchers will investigate the dynamic change of plasma vitamin D level. Afterward, intravenous supplement of vitamin D was added to this model to demonstrate vitamin D can ameliorate cholestasis. An in vitro system was developed to investigate the importance of FXR signaling pathway in this effect.


Eligibility criteria: Inclusion Criteria:

* Patients with short bowel syndrome supported by total parenteral nutrition.
* Patients have intestine more than 50cm.
* Requirements of informed consent and assent of participant, parent or legal guardian as applicable consciousness and ability cooperate.

Exclusion Criteria:

* Patients have obstruction of biliary tract, infection, autoimmune disease, cancer.
* Patients have intestine less than 50cm.
* A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease.
* Female with positive pregnancy.
* Allergy to ursodeoxycholic acid.

Primary outcomes:
measure: liver function
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT00286377: Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of Prosaptide Over 6 Weeks of Treatment for the Relief of Neuropathic Pain Associated With HIV-1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV
Peripheral Nervous System Disorders
Lead sponsor: Savient Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Neurologic AIDS Research Consortium (NARC)
First posted: 2006-02-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, placebo-controlled, parallel groups study to determine whether prosptide is effective in relieving pain in patients who have sensory neuropathic pain related to their HIV infection or the drugs used to treat it.

Detailed description: Sensory neruopathies are the most frequent neurological complicaton of HIV infection and its treatmet with antiretrovirals. To date, there are few effective treatments, and all are symptomatic treatments for pain. Management typically involves the intiation and adjustment of pain-modifying therapies, and the adjustment or discontinuation of potentially neurotoxic antiretrovirals, thereby limiting the choice of HAART regimens.

In precinical animal models,prosaptide has been shown to be efficacious in the treatment of neuropathic pain caused by a variety of different mechanisms.

Hypothesis: Prosaptide will improve neuropathic pain in HIV-associated sensory neuroathies,and will be safe and well tolerated in subjects.

Comparisons: 4, 8, or 16 mg prosaptide vs. placebo

Eligibility criteria: Inclusion Criteria:

* Ages 18 years and older

Primary outcomes:
measure: Differnece between the pain rating at Baseline vs. Week 6 (or last week)of treatment, based on the 13-point Gracely pain intensity scale as rated by subjects and captured in an electronic diary
Secondary outcomes:
measure: Difference between the Beline pain rating and each week of treatment.
measure: Number of subjects whoe were treatment successes at each week of the active treatment period.
Other outcomes:
Locations:
Study officials:
affiliation: Savient Pharmaceuticals, Inc.
name: Claudia Rehrig, MS
role: STUDY_DIRECTOR
References:
citation: Evans SR, Simpson DM, Kitch DW, King A, Clifford DB, Cohen BA, McArthur JC; Neurologic AIDS Research Consortium; AIDS Clinical Trials Group. A randomized trial evaluating Prosaptide for HIV-associated sensory neuropathies: use of an electronic diary to record neuropathic pain. PLoS One. 2007 Jul 25;2(6):e551. doi: 10.1371/journal.pone.0000551.
Clinical trial NCT02586077: Foot and Ankle Clinic Application for Liposomal Related Anesthetic
Official title: Foot and Ankle Clinic Application for Liposomal Related Anesthetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Arthrodesis
Hindfoot Arthrodesis
Tibitalocalceal Arthrodesis
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2015-10-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.

Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by the use of this modality.


Eligibility criteria: Inclusion Criteria:

* Any patient scheduled for ankle arthrodesis, a tibiotalocalcaneal arthrodesis, hindfoot arthrodesis including subtalar, double, triple, or isolated talonavicular arthrodesis
* Patients over the age of 18
* The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study

Exclusion Criteria:

* \< 18 years of age
* Patients with a history of infection
* Patients diagnosed with neuropathy or any form of numbness or loss of feeling in the arms or legs due to damaged nerves
* Patients having surgery on both feet at the same time
* Patients having any other different type of foot and ankle surgery

Primary outcomes:
measure: Amount of Narcotic Use
timeFrame: Surgery to post operative day 3
Secondary outcomes:
measure: Visual Analog Scale of Pain (0-10)
timeFrame: Post anesthesia care unit admission to post operative day 3
measure: Anti-emetic Use
timeFrame: After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3)
measure: Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief
timeFrame: Measured at hospital discharge (on post operative day 3)
measure: Number of Patients With Post-operative Complications
timeFrame: After surgery to the first scheduled clinic visit, usually 14 days after surgery
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina, PA
state: North Carolina
Study officials:
affiliation: OrthoCarolina Research Institute
name: Susan M Odum, PhD
role: STUDY_DIRECTOR
affiliation: OrthoCarolina Foot & Ankle Institute
name: Bruce Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03328377: The Gut Microbiota and Delirium in the ICU
Official title: The Association Between the Gut Microbiota Composition and Development of Delirium in ICU Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium of Mixed Origin
Microbial Colonization
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: University of Arkansas
First posted: 2017-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 40 ICU patients and 10 healthy volunteers as controls

Brief summary: To investigate whether the composition of the gut microbiota is different in patients that develop delirium during critical illness as compared to patients who do not.

Detailed description: We plan to include an equal number of patients admitted to the ICU, that either do or don't develop delirium during their course of critical illness. Samples of feces/rectal swaps will be taken at admission and again either when the patients become CAM-ICU positive, alternatively after 5 days admssion/at discharge in patients that remain CAM-ICU negative.

Samples are then sent to analyses for purification of bacterial DNA and metagenomic analysis.

Eligibility criteria: Inclusion Criteria: Admission to the ICU, Disability to make informed consent due to critical illness -

Exclusion Criteria: Dementia. Delirium diagnosed prior to the ICU admission on the non-ICU floors. Coma. Indication for deep sedation (-4/-5).

-

Primary outcomes:
measure: Gut Microbiota composition
timeFrame: May 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03033277: Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
Official title: Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Primary Ovarian Insufficiency
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: The Third Affiliated Hospital of Guangzhou Medical University
First posted: 2017-01-26
Enrollment: 320
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been previously documented. Herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from POI.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with primary ovarian insufficiency;
2. Women between 20 and 40 years;
3. Have fertility requirements, husband has sperm;
4. Willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Primary amenorrhea;
2. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
3. Thyroid dysfunction;
4. Severe endometriosis;
5. Contraindications for pregnancy;
6. Prior personal history of ovarian cancer;
7. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
8. History of serious drug allergy or allergic constitution;
9. Autoimmune disease, history of severe familial genetic disease;
10. HIV+, hepatitis B, C;

Primary outcomes:
measure: Number of mature follicle
timeFrame: Up to 4 months
Secondary outcomes:
measure: Follicle-stimulating hormone (FSH) serum level
timeFrame: Up to 4 months
measure: Estradiol (E2) serum level
timeFrame: Up to 4 months
measure: Anti-Mullerian hormone (AMH) serum level
timeFrame: Up to 4 months
measure: Number of antral follicle development
timeFrame: Up to 4 months
measure: Ovarian volume
timeFrame: Up to 4 months
measure: Pregnancy rate
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Zoology, Chinese Academy of Sciences.
state: Beijing
Study officials:
affiliation: State Key Laboratory of Stem Cell and Reproductive Biology
name: Hongmei Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00381277: The Effects of Sports Drinks on Urinary Lithogenicity
Official title: The Effects of Sports Drinks on Urinary Lithogenicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Keywords: nephrolithiasis
citrate
oxalate
Lead sponsor: VA New York Harbor Healthcare System
Sponsor class: FED
First posted: 2006-09-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The effect of sports drinks on the tendency to form kidney stones has not been assessed. Patients will drink 1 liter a day of 2 sports drinks and collect urine to determine changes in urine chemistry that may decrease the risk of forming stones.

Detailed description: Participants will drink 1 liter of water each day for one week in the control period, then 1 liter of sports drink each day for one week during the experimental period. Urine collections will be performed during both periods. Diet will be chosen by participants and a food diary will be kept so that participants can replicate diet during the urine collections.

Eligibility criteria: Inclusion Criteria:

* age 18-80 years old
* men and women
* able to sign informed consent

Exclusion Criteria:

* history of kidney stones
* bone disease
* parathyroid disease

Primary outcomes:
measure: Urinary supersaturation of calcium oxalate
measure: Urinary citrate excretion
measure: Urinary calcium excretion
measure: Urinary sodium excretion
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Harbor VAMC
state: New York
Study officials:
affiliation: New York Harbor VAMC
name: David S Goldfarb, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01859377: Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product.


Eligibility criteria: Inclusion Criteria:

* Healthy male subject aged 18 to 45 years (inclusive),
* 18.5 \< or = Body Mass Index \< or = 30 kg/m²,
* Non-smoker for at least 6 months
* Subject agreed to be registered in the Belgium national register "VIP Check International" for this study participation .

Exclusion Criteria:

* Positive serology for Hepatitis B Virus antigens, Hepatitis C Virus or Human Immunodeficiency Virus 1 or 2 antibodies,
* Organic disorder likely to modify absorption, distribution or elimination of the medication,
* History of sensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) or to any of the excipients
* Subject who has donated blood within the past 3 months,
* Subject who has forfeited his freedom by administrative or legal award, or who is under guardianship or who has been admitted in a sanitary or social institution,
* Participation in another clinical trial in the previous month or subject still within the exclusion period of a previous clinical trial or is participating in another clinical trial,

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 11 time points up to 10h after administration
measure: Time of Maximum Concentration
timeFrame: 11 time points up to 10h after administration
measure: Area Under Curve (AUC0-72)
timeFrame: 11 time points up to 10h after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
Study officials:
References:
Clinical trial NCT00285077: Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease
Official title: Long-Term Safety Extension of Phase II Study EFC5286 of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Alzheimer disease
nerve growth factors
Clinical Trial
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-01
Enrollment: 390
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD).

A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B.

Detailed description: Multinational, multicenter, randomized, parallel-group, double-blind, phase II study

Eligibility criteria: Inclusion Criteria:

* Patients who have participated in Study EFC5286 and completed the study.
* Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures specifically for this LTS5283 extension.

Exclusion Criteria:

* Females who are pregnant or breast-feeding.
* Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit,and must use an acceptable method of birth control.

Primary outcomes:
measure: Adverse events recorded quarterly.
Secondary outcomes:
measure: ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months.
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Horslholm
country: Denmark
facility: Sanofi-Aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Scientific Advisory Committee
name: Serge GAUTHIER, MD
role: STUDY_CHAIR
affiliation: Scientific Advisory Committee
name: Jean-Marc ORGOGOZO, MD
role: STUDY_CHAIR
affiliation: Scientific Advisory Committee
name: Philip SCHELTENS, MD
role: STUDY_CHAIR
affiliation: Scientific Advisory Committee
name: Bengt WINBLAD, MD
role: STUDY_CHAIR
References: