louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01815190: IgA-positive Versus IgA-negative Immune Complex Vasculitis
Official title: Retrospective Analysis of Frequency of Systemic Involvement in IgA-positive Cutaneous Immune Complex Vasculitis Versus IgA-negative Cutaneous Immune Complex Vasculitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cutaneous Vasculitis
Keywords: immune complex vasculitis
cutaneous vasculitis
IgA vasculitis
IgA nephropathy
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2013-03-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients of the department of dermatology in Muenster with histologically proven leukocytoclastic vasculitis in files in last 10-20 years

Brief summary: Cutaneous vasculitis due to vascular deposition of large circulating immune complexes is a disease frequently seen by general practitioners and dermatologists. The clinical symptom is palpable purpura with predilection for the lower legs.

In some cases vasculitis also affects systemic organs, such as the kidneys and the intestine.

When the immune complexes contain immunoglobulin class A (IgA) and when there is systemic involvement, the disease has been referred to as Henoch Schönlein purpura.

When there are no signs of systemic involvement, the disease has been referred to as cutaneous leukocytoclastic angiitis.

The investigators hypothesize that palpable purpura with predilection for lower legs is a pathognomonic clinical sign for immune complex vasculitis in both IgA vasculitis and IgA-negative vasculitis, but that only the presence of IgA in immune complexes is likely to be associated with systemic involvement and therefore warrants more extensive diagnostic procedures Vice versa the investigators postulate that the presence of IgG or IgM without IgA in immune complexes excludes systemic involvement The investigators also want to investigate to which of the 2 groups patients with palpable purpura and negative immunofluorescence should be assigned.


Eligibility criteria: Inclusion Criteria:

* histologically proven leukocytoclastic vasculitis
* clinically palpable purpura

Exclusion Criteria:

* no histological confirmation
* relevant data missing in file

Primary outcomes:
measure: Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Dermatology, Univ hospital of Muenster
Study officials:
affiliation: Department of Dermatology, Univ Hospital of Muenster
name: Cord Sunderkoetter, Prof Dr MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05667090: Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
Official title: Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis
Chronic Pain
Hyperparathyroidism
Keywords: Vitamin D supplementation
Mega-dose vitamin D
Cholecalciferol
Chronic pain
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain is a major complaint in hemodialysis (HD) patients. Concentrations of parathyroid hormone (PTH) \>250 pg/ml are associated with chronic pain. Visual Analogue Scale (VAS) score which is used to assess the pain severity is positively related to PTH levels. This study is aimed to assess the effects of multiple mega dosages vitamin D supplementations in HD patients with chronic pain. It's a single-center, parallel, double-blind randomized control trial that administrations of 576,000 IU once a week of vitamin D3 for 4 weeks or placebo are for 120 eligible subjects. VAS and laboratory tests including serum concentrations of 25(OH)D, calcium, phosphorus, PTH and C-reactive protein will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Haemodialysis subject ≥ 20 years old
2. iPTH \> 250 pg/mL
3. Chronic pain with visual analogue scale (VAS) score ≥ 4
4. Voluntary to check serum 25(OH)D levels two times by his/her own payment during the study
5. Sign the informed consent

Exclusion Criteria:

1. Used to participate in other clinical trials
2. Chronic liver disease
3. Sarcoidosis or multiple myeloma

Primary outcomes:
measure: Visual Analogue Scale of Pain
timeFrame: Baseline (day 1)
measure: Visual Analogue Scale of Pain
timeFrame: week 2 (day 8)
measure: Visual Analogue Scale of Pain
timeFrame: week 3 (day 15)
measure: Visual Analogue Scale of Pain
timeFrame: week 4 (day 22)
measure: Visual Analogue Scale of Pain
timeFrame: week 5 (day 29)
Secondary outcomes:
measure: 25(OH)D level
timeFrame: Baseline (day 1) and week 5 (day 29) post-supplementation
measure: Serum calcium
timeFrame: Baseline (day 1) and week 5 (day 29) post-supplementation
measure: Serum phosphorus
timeFrame: Baseline (day 1) and week 5 (day 29) post-supplementation
measure: C-reactive protein (CRP) test
timeFrame: Baseline (day 1) and week 5 (day 29) post-supplementation
measure: Concentrations of parathyroid hormone (PTH)
timeFrame: Baseline (day 1) and week 5 (day 29) post-supplementation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
References:
Clinical trial NCT06969690: Question-Order Effect Experiment to Measure HIV Stigma
Official title: Question-Order Effect Experiment to Measure HIV Stigma Among Persons With HIV (PWH) in Rural Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV stigma
discrimination
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
name: National Institute of Mental Health (NIMH)
First posted: 2025-05-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Question-order effect experiment to measure HIV-related stigma among people living with HIV (PWH).

Detailed description: HIV-related stigma is a barrier to engagement in HIV prevention and treatment. Given the negative impact of stigma on the HIV continuum of care, accurate assessment of HIV-related stigma among people living with HIV (PWH) in resource-limited settings is paramount. The purpose of this study is to conduct a question order experiment to assess the extent to which the order of presented questions affects measurement of HIV-related stigma.

Eligibility criteria: Inclusion Criteria:

- All HIV-positive (self-reported) adults who consider Nyakabare their primary place of residence and who are capable of providing consent

Exclusion Criteria:

* Minors younger than 18 years of age, with the exception of emancipated minors
* Persons who do not consider Nyakabare Parish their primary place of residence, e.g. persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside of the parish
* Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
* Persons who are not HIV positive

Primary outcomes:
measure: Self-esteem
timeFrame: Baseline (assessed at the time the survey is administered)
measure: Self-respect
timeFrame: Baseline (assessed at the time the survey is administered)
measure: Experiences of harassment due to HV status
timeFrame: Baseline (assessed at the time the survey is administered)
Secondary outcomes:
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: Massachusetts General Hospital
name: Alexander C Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04543890: A Prospective Study Comparing Two Radiotherapy Dose/Fraction and Omitting CTVs of the Primary Tumor in Limited SCLC
Official title: A Multicenter, Prospective, Randomized Study Comparing Hypofractionated Radiotherapy With Hyperfractionated Radiotherapy Combined With Concurrent Chemotherapy and Omitting Clinical Target Volumes of the Primary Tumor in Limited-stage SCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer Limited Stage
Keywords: radiotherapy
chemotherapy
radiation dose
radiotherapy target volume
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Chinese PLA General Hospital
name: Guangdong Medical College
First posted: 2020-09-10
Enrollment: 300
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: For most of the patients with limited-stage SCLC, thoracic radiotherapy combined with chemotherapy is the standard treatment at present. However, the optimal dose / fraction of thoracic radiotherapy for limited-stage SCLC is still in controversial.This study is designed as a prospecitive randomized non-inferiority trial.


Eligibility criteria: Inclusion Criteria:

1. Histologically/cytologically confirmed diagnosis of SCLC.
2. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
3. Patients should be between 18 and 75 years old.
4. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
5. With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
6. With weight loss no more than 10% within 6 months before diagnosis.
7. Informed consent must be signed.

Exclusion Criteria:

1. Histology confirmed the mixed NSCLC components;
2. Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
3. Any disease or condition contraindicated by radiotherapy or chemotherapy;
4. Malignant pleural effusion and pericardial effusion;
5. Pregnant and lactating women;
6. The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT00502190: Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG (EPEGE)
Official title: Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Twin Pregnancy
Keywords: pessary
extending pregnancy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-07-17
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea

Detailed description: Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea To show that the use of pessary makes it possible to lengthen the duration of the pregnancy of at least 10 days in patients with a twin pregnancy and a uterine collar length \< = 25 mm measured by echography between 20 and 28 SA compared to the group controls.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years (legal majority in France)
* Inclusion pessary positioning before 28 WG
* Twin pregnancies, mono or dichorionic, diamniotic
* Transvaginal cervical length ( 25mm between 20 et 28 WG
* Intact membranes
* No signs of infection (negative urine culture, CRP \<10mg/l , blood white cell count \<15000/ml)
* Patient accepting follow-up
* Covered by health insurance for France

Exclusion Criteria:

* Cerclage

  * No more cervix
  * Chorioamnionitis
  * Abnormal CTG
  * Placenta praevia
  * Abruptio
  * Bleeding
  * PROM
  * Singleton or multiple \>2
  * Monochorionic monoamniotic twin pregnancy
  * IUGR
  * Preeclampsia or other PIH
  * TTTS
  * Uncontrolled diabetes
  * Other maternal of fetal pathology responsible for preterm deliveries
  * Patient included in other therapeutic trials
  * Patient without legal freedom to consent
  * Homeless or no fixed address

Primary outcomes:
measure: Demonstrate the profit of 10 days in the pessary group compared to control.
timeFrame: at least 10 days
Secondary outcomes:
measure: To evaluate and compare the frequency of the childbirth < 34 SA
timeFrame: before 34 weeks
measure: Deliveries (<34WG)
timeFrame: 34 weeks
measure: Evaluate the rate of side effects of pessaries
timeFrame: during the pessaries
measure: Neonatal outcome
timeFrame: before 28 weeks
Other outcomes:
Locations:
city: Poissy
country: France
facility: Hopital POISSY-ST GERMAIN EN LAYE
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jacky NIZARD, CCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03592290: Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
Official title: Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypovolemia
Hemodynamic Instability
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers aged 20-45 with no history of heart disease, diabetes, or hypertension. Pregnant women will be excluded.

Brief summary: To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.

Detailed description: The primary aim of this research is to identify the most robust site for monitoring hypovolemia as well as assess changes in peripheral waveforms monitored by the pulse oximeter collected from different sites (finger, ear, forehead, and nose), blood pressure, cerebral oximetry and peripheral venous pressure during gradual hypovolemia induced by lower body negative pressure (LBNP) in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

\* Healthy volunteers aged 20-45 with

Exclusion Criteria:

* Pregnant women
* Under 20 years of age
* Subjects with coronary artery disease, diabetes, epilepsy and hypertension

Primary outcomes:
measure: Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms.
timeFrame: 2 years
Secondary outcomes:
measure: Examine the relationship between central hemodynamic changes (cardiac output) with changes in respiratory variability of PPG waveforms collected from different sites during hypovolemia and fluid resuscitation
timeFrame: 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: John B. Pierce Laboratory
state: Connecticut
Study officials:
affiliation: Yale University
name: Aymen Alian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03902964: Needs Assessment After Cancer in Patients Treated for Breast Cancer
Official title: Needs Assessment After Cancer in Patients Treated for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasm Female
Quality of Life
Fear Cancer
Lead sponsor: Institut Jean-Godinot
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 139
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who completed breast cancer treatment between January 1 and May 31, 2017, and between January 1 and 31 May 2015. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random in each of the 2 cohorts.

Brief summary: observational monocentric study

Detailed description: observational monocentric study

Primary objective :

Describe post-cancer supportive care needs, assessed by questionnaire in patients treated for breast cancer after completion of treatment and 2 years later.

Secondary objective :

* Correlation between needs after cancer and the fear of recidivism assessed by the scale of the inventory of fear.
* Compare the need for supportive care between the end of treatment and 2 years after.
* Assess needs after cancer according to the stage of the disease
* Evaluate the needs after cancer according to the treatments received: surgery-radiotherapy versus surgery-chemotherapy-radiotherapy.
* Assess needs after cancer according to age and socio-professional category.

Schedule :

The selected patients then received a letter including an information and non-objection note, the post-cancer needs questionnaire, the Fear Inventory severity subscale questionnaire, and the QLQ-C30 questionnaire. A delay of 1 month was chosen to return the questionnaire with a phone call after 15 days for an analysis of responses in February 2019.

Eligibility criteria: Inclusion Criteria:

Women who have been treated for breast cancer and whose treatment ended in 2017 (cohort A) and in 2015 (cohort B), aged between 18 and 80 years, and who declared their non-opposition free and enlightened.

Exclusion Criteria:

Patients who have been treated for recurrence or 2nd cancer, metastases from the outset, male, refusal to participate.

Primary outcomes:
measure: Post-cancer needs analysis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Institut Jean Godinot
Study officials:
affiliation: Institut Jean-Godinot
name: stephanie SERVAGI VERNAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00357864: Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Official title: Basic Research on Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow in a Humane Experimental Headache Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2006-07-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: To investigate headache score and accompanying symptoms during and after infusion of carbachol.

Detailed description: To investigate headache score and accompanying symptoms during and after infusion of carbachol.

Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Aged 18-40
* 50-100 kg
* Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

Exclusion Criteria:

* Tension type headache more than once/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Dansih Headache Center
Study officials:
affiliation: Danish Headache Center
name: henrik schytz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00381264: Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis
Official title: A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to Multiple Sclerosis.

Detailed description: The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to Multiple Sclerosis.

This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due MS. The study has two phases: a Pretreatment Phase and a Treatment Phase.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with MS
* Chronic daily pain present for at least 2 months.
* On stable analgesic regimen for one month
* Baseline pain score greater than 40mm on a visual analog scale.

Exclusion Criteria:

* Hypersensitivity to compounds in study drug or similar drugs
* Pregnant or lactating females
* Drug or alcohol abuse
* Unstable medical condition

Primary outcomes:
measure: The Average Pain Score at target site.
Secondary outcomes:
measure: The Worst Pain Score at target site.
measure: The Pain at Night Score at target site.
measure: Quality of Life measures.
measure: Patient satisfaction with treatment.
measure: Safety will be assessed through the collection of AEs and vital signs.
Other outcomes:
Locations:
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research, Inc.
state: Florida
city: Naples
country: United States
facility: Naples Anesthesia and Pain Associates
state: Florida
city: West Palm Beach
country: United States
facility: Lazlo Mate, MD
state: Florida
Study officials:
affiliation: NEMA Research, Inc.
name: Joseph V Pergolizzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nema Research
name: Charlotte A Richmond, PhD
role: STUDY_DIRECTOR
References: