louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04068090: Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer
Official title: Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 500
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese breast cancer patients treated with taxanes

Brief summary: The purpose of this study is to collect clinical data, blood samples, and self reported symptoms of peripheral neuropathy from Chinese patients with breast cancer after treatment with taxanes. This data will be used to develop predictive markers for neuropathy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of breast cancer
* Females aged 16 and older
* Planning to receive or previous treated with taxanes

Exclusion Criteria:

* Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity

Primary outcomes:
measure: Total score from the FACT-GOG-Ntx questionnaire
timeFrame: Up to 2 years
Secondary outcomes:
measure: Predictive value of genetic variants for the development of neuropathy
timeFrame: In the two weeks before start treatment
measure: Total score from the EORTC QLQ - CIPN20 questionnaire
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT03063190: Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease
Official title: Evaluation of Cholecalciferol Supplementation in Chronic Kidney Disease Patients With Restless Leg Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Restless Leg Disorder
Renal Disease Bone
Renal Disease, End Stage
Hyperparathyroidism, Secondary
Adynamic Bone Disease
Vitamin D Deficiency
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 0
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: Restless leg syndrome (RLS) is sleep disorder characterized by an unpleasant feeling in the lower limbs, which can be accompanied by paresthesias, and need for urgent movement of the legs. Its diagnosis is clinical, based on an International Committee of the Study of RLS (International Restless Legs Syndrome Study) questionnaire. Its prevalence is about 5-15% in the general population, being twice as frequent in women and with a tendency to increase incidence with aging. In the chronic kidney disease (CKD) population, mainly in patients on dialysis, the prevalence increases by up to 70%. Vitamin D deficiency is associated with RLS and active vitamin D supplementation seems to improve RLS and severity. It is seems, studies on the role of vitamin D supplementation in CKD population are missing. The clinical-scientific hypothesis of this study is that replacement of vitamin D (cholecalciferol) will improve the symptoms of RLS. As parathyroidectomy can relieve RLS, the aim of researchers is to randomize patients with CKD on dialysis to receive cholecalciferol or placebo in 2 distinct groups: secondary hyperparathyroidism and adynamic bone disease.


Eligibility criteria: Inclusion Criteria

- adult patients with chronic kidney disease on dialysis, with vitamin D deficiency.

Exclusion Criteria

* current treatment for restless leg syndrome
* history of parathyroidectomy in the last 6 months

Primary outcomes:
measure: Improvement RLS severity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas
state: SP
Study officials:
References:
Clinical trial NCT01118390: Treatment of Leg Telangiectasias With Nd:YAG 1064nm
Official title: Treatment of Leg Telangiectasias With Nd:YAG 1064nm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Telangiectasias
Keywords: telangiectasias
leg
sclerotherapy
laser
glycose
Lead sponsor: Grupo de Cirurgia Vascular
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with leg telangiectasias

Exclusion Criteria:

* Arterial disease
* Varices
* Diabetes

Primary outcomes:
measure: treatment of leg telangiectasias
timeFrame: first day
measure: Treatment of telangiectasias
timeFrame: 1 month
Secondary outcomes:
measure: Presence of adverse effects
timeFrame: after 1 month
measure: Pain Scores on the Visual Analog Scale
timeFrame: After 1 month
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da FMUSP
Study officials:
affiliation: Hospital das Clinicas, University of Sao Paulo
name: Nelson Wolosker, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital das Clinicas, University of Sao Paulo
name: Marco Munia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. doi: 10.1126/science.6836297.
citation: Coles CM, Werner RS, Zelickson BD. Comparative pilot study evaluating the treatment of leg veins with a long pulse ND:YAG laser and sclerotherapy. Lasers Surg Med. 2002;30(2):154-9. doi: 10.1002/lsm.10028.
citation: Baumler W, Ulrich H, Hartl A, Landthaler M, Shafirstein G. Optimal parameters for the treatment of leg veins using Nd:YAG lasers at 1064 nm. Br J Dermatol. 2006 Aug;155(2):364-71. doi: 10.1111/j.1365-2133.2006.07314.x.
citation: Dudelzak J, Hussain M, Goldberg DJ. Vascular-specific laser wavelength for the treatment of facial telangiectasias. J Drugs Dermatol. 2009 Mar;8(3):227-9.
Clinical trial NCT01109290: Characterization of Sweat Gland Function in Patients With Recessively Inherited Hypohidrotic Ectodermal Dysplasia
Official title: Validation of Non-invasive Technologies for the Characterization of Sweat Gland Function in Patients With Recessively Inherited Hypohidrotic Ectodermal Dysplasia, Their Heterozygous Family Members and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypohidrotic Ectodermal Dysplasia
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
Collaborators: name: Edimer Pharmaceuticals
First posted: 2010-04-23
Enrollment: 65
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with recessively inherited hypohidrotic ectodermal dysplasia (HED), their heterozygous family members and healthy controls

Brief summary: Hypohidrotic ectodermal dysplasia (HED) is a complex genetic disorder characterized by lack of sweat glands, sparse hair, and missing or malformed teeth. Inability to sweat may result in episodes of severe hyperthermia and cause sudden infant death. To assess sweat gland function in HED patients, the investigators will first quantify gland pores in a defined area of the palm and then stimulate the glands by pilocarpine followed by sweat collection in a special capillary for volume determination. This will be combined with non-invasive skin conductance measurement prior and subsequent to stimulation of the sympathetic nervous system. The data should provide a basis for genotype-phenotype correlation.


Eligibility criteria: Inclusion Criteria:

* for patients: hypohidrotic ectodermal dysplasia caused by mutations in the genes EDA or EDAR
* written informed consent

Exclusion Criteria:

* febrile disease
* pregnancy or breastfeeding
* implantable electronic devices, e.g. pacemaker
* hypersensitivity to self-adhesive electrodes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
state: Bavaria
Study officials:
affiliation: University Hospital Erlangen
name: Holm Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01097590: A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis
Official title: A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis
leukapheresis treatment
Lead sponsor: IBD Column Therapies International AB
Sponsor class: INDUSTRY
First posted: 2010-04-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a treatment of a novel leukapheresis column is safe and effective in patients with moderate to severe ulcerative colitis.

Detailed description: Ulcerative colitis (UC) is a chronic and relapsing disease and is characterized by superficial inflammation in the colonic epithelium. The inflammation is maintained by continuous supply of inflammatory cells from the circulating blood to the intestinal mucosa.

Existing therapy e.g. corticosteroids and immunosuppressants are inadequate with an overall long-term remission rate of only 50-60%. Those treatments are also associated with severe side effects why there is a need of new therapies.

The aim of this study is to investigate a novel leukapheresis treatment with the potential to reduce the number of inflammatory cells homing to the gut mucosa. By drawing blood from the patient and pass it through the investigational column the inflammatory cells are removed. The blood, depleted of the inflammatory cells, is returned to the patient.

The treatment thus enable down-regulation of the inflammation and consequently the inflammation can heal. The treatment is called Tailored leukapheresis.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of active, moderate-to-severe, Ulcerative Colitis.

Exclusion criteria;

* Local intestinal treatments with suppositories, enemas or clysmas during the last 4 weeks
* Current daily smoking habits
* Other severe diseases as detailed in the protocol
* History of hypersensitivity to heparin

Primary outcomes:
measure: Expression level of MHC class II on antigen presenting cells.
timeFrame: change from baseline at day 5, 12, 28, 42 and 98.
Secondary outcomes:
measure: The number of cells and/or expression level of gut homing and activation markers on lymphocytes and monocytes. Safety and tolerability. Clinical effect on signs and symptoms of the disease.
timeFrame: change from baseline at day 5, 12,28, 42, 98.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Karolinska Universitetssjukhuset 171 76 Stockholm
name: Michael Eberhardson, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05858190: Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study
Official title: Comparison of Drug Eluting Balloon and Plain Old Balloon for the Treatment of Non-atherosclerotic Renal Artery Stenosis--A Protocol of a Multicenter Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension, Renovascular
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will test the efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis. The DEB (paclitaxel eluting balloon) will be used in the intervention group, while the plain old balloon(POB) will be used in the control group. The primary outcome is the effect of blood pressure control.


Eligibility criteria: Inclusion Criteria:

* age between 18y and 45y.
* with ≥ 60% stenosis in at least one renal artery.
* with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg).
* patients with no severe renal insufficiency (eGFR\>30 ml/min, length of the kidney ≥ 7cm).
* Good compliance.
* with informed consent.

Exclusion Criteria:

* With apparent atherosclerotic risk factors.
* With renal intervention or surgery history.
* With congenital anatomical anomaly.
* With severe renal insufficiency (length of the target kidney \< 7cm, total
* eGFR\<30ml/min, divided eGFR of the target kidney\<8 ml/min)
* With contraindication for antiplatelet therapy.
* With severe cardiopulmonary insufficiency.
* Allergic to contrast medium
* Being pregnant or preparing for pregnancy
* With active cancer.
* Life expectancy \< 12 month
* Without informed consent

Primary outcomes:
measure: Primary patency rate
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03659890: Dietary Nucleotides and Ribose on Muscle Fuel Utilisation
Official title: The Effect of Dietary Nucleotides and Ribose on Muscle Fuel Utilisation and Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Nucleotides are the building blocks for a variety of molecules, including ATP, which is broken down in the skeletal muscle cells to provide fuel for exercise. Nucleotides can be obtained from the diet, and produced or salvaged by the body. Though nucleotides provide the building blocks for ATP, the sugar ribose has been suggested to be rate limiting for synthesising ATP.

Previous studies have shown a decrease in ATP levels in the muscle after intense exercise, and this is linked to fatigue. Other studies have also reported benefits of nucleotide and/or ribose supplementation on exercise performance. However, any potential link between ATP metabolism and exercise performance has not been explored.

This study will look at the effects of nucleotide and nucleotide-ribose supplementation in fuel utilisation and performance in skeletal muscle during endurance exercise.


Eligibility criteria: Inclusion Criteria:

* BMI between 18 and 30

Exclusion Criteria:

* On medication (except contraception)
* Smokers
* Diagnosed with any metabolic or cardiovascular conditions
* Muscle or bone injuries
* BMI \< 18 or \> 30

Primary outcomes:
measure: Changes in muscle ATP concentrations
timeFrame: After each supplementation cycle (day 15 of each cycle): baseline (fasted and before exercise), immediately after glycogen depleting exercise (after exercising for 1:30 - 2 hours), immediately after 15 minute time trial and after 3-hour recovery
Secondary outcomes:
measure: Changes in muscle glycogen concentrations
timeFrame: After each supplementation cycle (day 15 of each cycle): baseline (fasted and before exercise), immediately after glycogen depleting exercise (after exercising for 1:30 - 2 hours), immediately after 15 minute time trial and after 3-hour recovery
measure: Blood lactate concentrations
timeFrame: After supplementation cycle (day 15): baseline and at 15 minute intervals up 1 hour during glycogen depleting exercise
measure: Blood glucose concentrations
timeFrame: After supplementation cycle (day 15): baseline and at 15 minute intervals up 1 hour during glycogen depleting exercise
measure: Serum uric acid concentrations
timeFrame: Measured at baseline and of days 6, 8 and 15 of each supplementation cycle
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter - St Luke's Campus
state: Devon
Study officials:
References:
Clinical trial NCT05134090: Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.
Official title: Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation: a Single-center Experience.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology
Fertility Issues
Surgery
Keywords: Percuvataneous laparoscopy
Ovarian Tissue Cryopreservation
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with histological diagnosis of malignancy during reproductive age undergoing ovarian tissue explant for ovarian tissue cryopreservation, from Aug 2017 to Jun 2021.

Brief summary: To compare surgical outcomes of oncologic patients that underwent conventional laparoscopy and percutaneous laparoscopy for cryopreservation of ovarian tissue.

Detailed description: This is a retrospective analysis to evaluate the efficacy and safety of percutaneous laparoscopy for the ovarian tissue explant in oncologic women. Surgical outcomes of patients that underwent percutaneous laparoscopy were compared with those of women that underwent conventional laparoscopy. Data from 2017 to 2021 were collected in a single Oncologic Center in Italy. The principal outcomes considered are post-operative pain, recovery time and aesthetic outcomes.

Eligibility criteria: Inclusion Criteria:

* Oncologic women with desire to preserve fertility

Exclusion Criteria:

* Ovarian explant with different techniques than laparoscopy

Primary outcomes:
measure: Post-operative pain
timeFrame: 0-1 and 2 days after surgery
measure: Aesthetic outcomes
timeFrame: minimum 3 months after surgery
Secondary outcomes:
measure: Recovery time
timeFrame: Days
measure: Operative time
timeFrame: 1 day
measure: Blood loss
timeFrame: 1 day
measure: Surgical complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS "Regina Elena" National Cancer Institute
state: Lazio
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Benito Chiofalo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiofalo B, Bruno V, Calandra M, Savone D, Mancini E, Baiocco E, Iacobelli M, Giannini A, Vizza E. Percutaneous-assisted laparoscopy for ovarian tissue cryopreservation: a single-center experience. Arch Gynecol Obstet. 2022 Oct;306(4):1329-1335. doi: 10.1007/s00404-022-06684-0. Epub 2022 Jul 10.
Clinical trial NCT01354990: A Post Marketing Safety Study of Sitagliptin (JANUVIA®) (MK-0431-234)
Official title: Sitagliptin (JANUVIA®) Post Marketing Surveillance Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-05-17
Enrollment: 2974
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with type 2 diabetes mellitus who are treated with sitagliptin as per the standard of care in a physician's practice

Brief summary: The primary objective of this study is to obtain safety information on the use of sitagliptin (JANUVIA®) from endocrinologists, diabetologists, internists, and general practitioners.


Eligibility criteria: Inclusion Criteria:

- Must be taking sitagliptin (JANUVIA™) for the treatment of type 2 diabetes

mellitus

- Treating physician must agree to provide information regarding the participants treatment

Primary outcomes:
measure: Number of Participants With an Adverse Event
timeFrame: Up to approximately 28 months
measure: Age of Participants Prescribed Sitagliptin
timeFrame: Up to approximately 28 months
measure: Number of Participants With Concomitant Therapies
timeFrame: Up to approximately 28 months
measure: Number of Participants With Concomitant Conditions
timeFrame: Up to approximately 28 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02744690: Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia
Official title: Topical vs Injection Application of Mitomycin C Trabeculectomy Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glaucoma
Keywords: Eye Disease
Intraocular Pressure
Visual Acuity
Trabeculectomy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Menelik II Hospital
First posted: 2016-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, double-masked trial to examine the response to trabeculectomy surgery. In this study, patients will be randomized to receive MMC via subconjunctival injection or topical sponge application.

Detailed description: This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, patients from Menelik Hospital who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive mitomycin C applied topically or by injection during the surgery.At Menelik Hospital mitomycin-C (MMC) is routinely applied to the eye prior to trabeculectomy by physicians via both sponge and injection routes. The primary outcome is the patient's response to the trabeculectomy procedure, as measured by cumulative complications after a 3-month follow-up period post-operation. Secondary outcome is the change in intraocular pressure after a 3 month follow-up period. The investigators will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.

Eligibility criteria: Inclusion Criteria:

* Age \>=40
* Planning to have a trabeculectomy

Exclusion Criteria:

* Life threatening or debilitating disease
* Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
* Pseudophakic lens
* Contralateral eye already enrolled in study

Primary outcomes:
measure: Cumulative incidence of complications
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Cumulative incidence of complications
timeFrame: 6 and 12 months after surgery
measure: Reduction of intraocular pressure from baseline, mmHg
timeFrame: 3, 6, and 12 months after surgery
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Menelik II Hospital
Study officials:
affiliation: University of California, San Francisco
name: Jeremy D Keenan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: