louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00713180: Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
Official title: Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium
Lead sponsor: Anguria, Peter, M.D.
Sponsor class: INDIV
First posted: 2008-07-11
Enrollment: 355
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to find out why pterygium occurs and recurs in a rural African population. Participants will be interviewed on personal and lifestyle information, family history of pterygium, environmental exposure and history of previous eye inflammation. They will undergo eye examination and photography. Those with pterygium will be operated on to remove pterygium and followed up to detect any recurrence and complications of surgery. The excised pterygium will be examined pathologically and genetically; participant's blood will also be examined genetically. Data will be analyzed for statistically significant differences in findings between pterygium and pterygium free participants.

The study hypothesis is that multiple factors are responsible for the occurrence and recurrence of pterygium in a rural african population.


Eligibility criteria: Inclusion Criteria:

1. Pterygium at least 1.5mm in extent
2. Both male and female
3. Age range 21-65 years
4. Consenting to participate in study
5. Unilateral and bilateral pterygium
6. All grades of pterygium

Exclusion Criteria:

1. Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
2. Pseudopterygium or signs of malignancy on pterygium
3. Recurrent pterygium
4. Sufferers of collagen vascular disease, scleritis or diabetes -

Primary outcomes:
measure: None recurrence of pterygium
timeFrame: 6 months of follow up after operation
Secondary outcomes:
measure: corneal scarring
timeFrame: 6 months of follow up
measure: tenon's granuloma
timeFrame: 6 months of follow up
measure: graft retraction
timeFrame: one month of follow up
measure: Graft haematoma
timeFrame: one week of follow up
measure: Graft hyperaemia
timeFrame: 3 months of follow up
Other outcomes:
Locations:
city: Polokwane
country: South Africa
facility: Mankweng Hospital
state: Limpopo
Study officials:
affiliation: Mankweng Hospital
name: Peter Anguria, MMed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04163380: Resistance Training and Sex Hormone Concentrations During the Menstrual Cycle
Official title: Acute Effects of Resistance Training on Sex Hormone Concentrations on Different Phases of the Menstrual Cycle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Women's Health
Keywords: Estrogen
Progesterone
Menstrual Cycle
Resistance Training
Lead sponsor: Southern Illinois University Edwardsville
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be blocked (four participants by block) and then randomized to start in one of the four menstrual cycle phases (EFP, LFP, ELP, or LLP). Their will be complete once they have gone through the four phases.
Primary purpose: TREATMENT

Brief summary: Although there are numerous studies showing effects of aerobic training on sex hormone concentrations, research analyzing the fluctuation of sex hormones in response to resistance training (RT) is lacking. The objective of this project is to analyze estradiol (E2) and progesterone (P4) responses to an acute resistance training session throughout different phases of the menstrual cycle. This proposed research has strong implications for exercise prescription and for women in general, but more importantly will allow exercise physiologists, coaches, personal trainers, or nutritionists optimize exercise programming around women's menstrual cycle.


Eligibility criteria: Inclusion Criteria:

* Eumenorrheic females
* Age 18-45 years old
* BMI of 18.5-34.99 kg/m2

Exclusion Criteria:

* Practice exercise more than 2 days/week in the last 3 months.
* Cardiovascular, metabolic, pulmonary or muscular-skeletal condition
* Taking medications that affect metabolism (e.g. oral contraceptives)
* Irregular menstrual cycles

Primary outcomes:
measure: Change in estrogen concentrations
timeFrame: through study completion, an average of 5 weeks
measure: Change in progesterone concentrations
timeFrame: through study completion, an average of 5 weeks
Secondary outcomes:
measure: Lean body mass (kg)
timeFrame: At baseline: 1 assessment point
measure: Fat mass (kg)
timeFrame: At baseline: 1 assessment point
measure: Relative body fat (%)
timeFrame: At baseline: 1 assessment point
measure: Skeletal muscle mass (kg)
timeFrame: At baseline: 1 assessment point
measure: Cardiorespiratory Fitness
timeFrame: At baseline: 1 assessment point
measure: Strength in Bench Press
timeFrame: At baseline: 1 assessment point
measure: Strength in Leg Press
timeFrame: At baseline: 1 assessment point
measure: Changes in diet
timeFrame: through study completion, an average of 5 weeks
Other outcomes:
Locations:
city: Edwardsville
country: United States
facility: Southern Illinois University Edwardsville
state: Illinois
Study officials:
References:
Clinical trial NCT01412580: In Utero Capacity Formation and Socio-economic Outcomes
Official title: The Contribution of Health in Utero to Capacity Formation, Education and Economic Outcomes: Experimental Evidence From Tanzania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Folic Acid Deficiency
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals from a larger study and this study is an observational follow-up.

Brief summary: Because of the high returns of schooling in developing countries, policymakers pay a lot of attention to increasing school access. But if the mother is deficient in key micronutrients, brain development can biologically constrain children's demand for education. To execute this strategy, the investigators collect cohort observational data on a previous randomized controlled trial with micronutrient supplements offered to HIV-negative pregnant women in Dar es Salaam, Tanzania, between 2001 to 2003.

Detailed description: This is a cohort study which collected follow-up observational data on households which were offered micronutrient supplements. The followup study outcomes include various socio-economic household characteristics and parental post-natal behaviors.

Eligibility criteria: These were individuals from the larger study and this study is an observational follow-up.

Primary outcomes:
measure: Children's Cognitive Development
timeFrame: During 2011-2012 (1 year)
measure: Children's Health
timeFrame: During 2011-2012 (1 year)
measure: Parental Postnatal Investment Behavior
timeFrame: During 2011-2012 (1 year)
measure: Educational Status
timeFrame: During 2011-2012 (1 year)
Secondary outcomes:
measure: Parental Labor Force Participation
timeFrame: During 2011-2012 (1 year)
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: MUHAS
Study officials:
affiliation: Harvard University
name: Plamen Nikolov
role: STUDY_DIRECTOR
References:
Clinical trial NCT00720980: Granuloma Annulare Treated With Rifampin, Ofloxacin, and Minocycline Combination Therapy
Official title: Granuloma Annulare Treated With Rifampin, Ofloxacin, and Minocycline Combination Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Granuloma Annulare
Keywords: granuloma annulare, ROM
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2008-07-23
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators reported 6 cases of resistant GA that resolved after a 3-month treatment course of monthly rifampin, ofloxacin, and minocycline (ROM) therapy. ROM therapy has been successfully used to treat patients with paucibacillary leprosy, which has morphologic and histologic similarities to GA.

Brief summary: Granuloma annulare is a benign, usually self-limiting, cutaneous dermatosis, which typically presents as asymptomatic, flesh-colored or red papules, frequently arranged in an annular pattern on the distal extremities. Although localized granuloma annulare is most commonly observed, a generalized or disseminated form can occur. The etiology of granuloma annulare is unknown, however, multiple inciting factors have been proposed. The purpose of the investigators is to review the outcomes of treatment of granuloma annulare (GA) resistant to standard regimens that resolved after a 3-months treatment course of monthly rifampin, ofloxacin, and minocycline (ROM) therapy, successfully used to treat paucibacillary leprosy, a disease with clinical and histopathologic similarity to GA.

Detailed description: We will document the regimen treatment each patient has had and then review the following from the patient's chart to target our specific aims as outlined above.

1. What previous treatment options have been or/are currently being used?
2. How long did the patient take the treatment for?
3. Was the patient able to discontinue or become less dependent on prior treatment?
4. Was the disease process slowed by the treatment?;
5. Were there any side effects that the patient experienced with treatment?

Eligibility criteria: Inclusion Criteria:

* Patients with granuloma annulare who are resistent to the standard treatment.

Exclusion Criteria:

* Response to the standard treatment of granuloma annulare.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Iltefat H Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duarte AF, Mota A, Pereira MA, Baudrier T, Azevedo F. Generalized granuloma annulare--response to doxycycline. J Eur Acad Dermatol Venereol. 2009 Jan;23(1):84-5. doi: 10.1111/j.1468-3083.2008.02707.x. Epub 2008 Apr 1. No abstract available.
Clinical trial NCT02694380: Measuring the Effect of Radiation Therapy on Patient Activity Levels
Official title: Measuring the Effect of Radiation Therapy on Patient Activity Levels
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Cancer
Prostate Cancer
Breast Cancer
Lung Cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential subjects are initially referred to the Department of Radiation Oncology for their primary cancer diagnosis. Subjects that fit the diagnosis for this study may be offered participation.

Brief summary: The goal of this study is to measure the effect of radiation therapy on the activity levels of patients. This will be achieved by tracking their activity levels during a treatment course of radiation therapy.

Detailed description: At the University of Pittsburgh (UPMC) St. Margaret and UPMC Shadyside, in the department of radiation oncology, breast, prostate, head and neck, and lung cancer patients will receive the standard treatment for their cancer and in no way will this study interfere with this treatment. Prior to initiation of radiation, consenting patients will be given Misfit activity tracking devices (accelerometers) to be worn on their wrist to track their activity levels throughout the course radiation therapy. Bracelets will be given to patients by the PI or co-investigators (MDs involved in patient's care) at date of consent and returned at completion of the study. The bracelets will track daily steps taken, calories burned, miles walked, and restful and restless sleep. Again, the purpose of the study is merely to measure the affect radiation therapy has on activity levels of patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Breast, Prostate, Lung or Head and Neck Cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Ability to walk 100 feet without rest
* Signed informed consent

Exclusion Criteria:

* Any other noncutaneous cancer diagnosis under active treatment
* Known metastatic disease

Primary outcomes:
measure: Activity level
timeFrame: up to 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC St. Margaret Department of Radiation Oncology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Department of Radiation Oncology
state: Pennsylvania
Study officials:
affiliation: UPMC Department of Radiation Oncology
name: Colin Champ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02392780: Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease
Official title: Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute-graft-versus-host Disease
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 10
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: Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.


Eligibility criteria: Inclusion Criteria:

1. Patients 18 years or older
2. After allogeneic transplantation
3. Grade III or IV acute GVHD
4. No psychiatric contra-indication
5. Informed consent

Exclusion Criteria:

1. History of psychosis
2. Asthma
3. Known allergy to cannabis constituents

Primary outcomes:
measure: Proportion of patients with complete remission of acute GVHD
timeFrame: 90 days
Secondary outcomes:
measure: Proportion of patients with partial remission of acute GVHD
timeFrame: 90 days
measure: Proportion of patients with chronic GVHD
timeFrame: 12 months
measure: Proportion of patients able to discontinue immunosuppression
timeFrame: 12 months
measure: Transplant related mortality
timeFrame: 12 months
Other outcomes:
measure: Subpopulations of peripheral blood cells and cytokine levels
timeFrame: 12 months
Locations:
city: Petach Tikva
country: Israel
facility: Davidof Cancer Center, Beilinson hospital, Rabin medical center
Study officials:
References:
Clinical trial NCT04105829: Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change
Official title: Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Color
Keywords: tooth color change
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare the tooth colour changes caused by retainers made of stainless steel wires and fiber reinforced in long term

Detailed description: 30 patients who were planned to use lower fixed retainer after fixed orthodontic treatment, were included in the study and divided into 3 groups. (n=10) (Group 1: Bond a braid retainer, Group 2: Ribbond retainer, Group 3: EverStick Ortho retainer). Colour measurements will be made with spectrophotometer (Vita easyshade) after debonding (T1), after retainer application (T2), in 1 month, 3 month, 6 month and finally 1 year from 6 lower anterior teeth. The Commission Internationale de I'Echairage L\*a\*b\* system will be used to determine the tooth colour. ∆E values measured at different times will be compared.

Eligibility criteria: Inclusion Criteria:

* patients with no anomalies of lower incisors and canine teeth

Exclusion Criteria:

* patients drinking more then 3 cups of coffee per day
* smoker patients

Primary outcomes:
measure: Tooth color change
timeFrame: before debonding, after debonding on 1st, 3rd, 6th months and 1st year
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
state: Şehitkamil
Study officials:
affiliation: University of Gaziantep
name: Merve Goymen, PhD
role: STUDY_CHAIR
affiliation: University of Gaziantep
name: Derya Sürmelioğlu
role: STUDY_CHAIR
References:
Clinical trial NCT06020729: Effects of Occlusion Training on Hockey Players
Official title: Effects of Occlusion Training on Speed and Physical Performance in Hockey Players
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sports Physical Therapy
Keywords: field hockey, muscle hypertrophy, occlusion training, power
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 18
Sex: MALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Occlusion training is simply a way of restricting blood flow in the veins of a working muscle in hopes to kick-start some larger gains in muscle size and strength. Occlusion training performed during hockey training on speed and physical performance of hockey players. This training also known as blood flow restriction training, can be defined as the training of muscles while limiting blood flow to the muscles and typically done by performing high intensity, low weight, lifts while using some form of tourniquet or band to limit blood supply to limb being trained.

Detailed description: This study will be a randomized controlled trial and total sample size of both groups will be 18 and calculated through non-probability sampling technique and the players will allocate into two groups, control group and experimental group, per group sample size is 9. Each will perform the session for occlusion training. Before and after training sessions players completed a series of test to assess their speed and physical performance. Occlusion training will help us providing unique beneficial training mode for promoting muscle hypertrophy. In control group players will perform general exercises session and in experimental sessions players will perform with occlusion training which is blood flow resistance training (BFR training shoulder, leg extension, bicep curls, kaatsu) 4 times a week for 4 weeks with 5 sets of 5 repetitions and then assessed pre-training and post-training values with assessment tools bench press, leg squat, leg power, maximum sprint time and pull-ups performed at 70% of 1-repetition maximum. This training will also improve and increase muscular strength in players.

Eligibility criteria: Inclusion Criteria:

* Male
* Athletes with age group of 19-30 years of age.
* All players who had a minimum of two years of resistance training experience

Exclusion Criteria:

* Systemic issues with orthopedic issue, fractures, neuromuscular issue, cardiac issues.
* Players having history of prior surgery.

Primary outcomes:
measure: SQUATS
timeFrame: 4 weeks
measure: BENCH PRESS
timeFrame: 4 WEEKS
measure: MAXIMUM TIME SPRINT
timeFrame: 4 WEEKS
measure: LEG POWER
timeFrame: 4 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Sports Board
state: Punjab
Study officials:
affiliation: Riphah International University
name: Amna Shahid, t-DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01457729: Ergometer Training in Patients With OSA
Official title: Telemedizinisches Trainings-Monitoring Von Patienten Mit Obstruktivem Schlafapnoesyndrom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: ergometer
training
motivation
telemonitoring
sleep apnea
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard bike ergometer which is additionally equipped with a system to gather training data and the ability to send daily training time to an internet server to which the physician has access. Training time of two groups is compared. Group one is not motivated while group two benefits from telephone feedback when training time declines. It is presumed that training time increases with better information and response to training behaviour.


Eligibility criteria: Inclusion Criteria:

1. Suspected OSA
2. Capable of giving consent

Exclusion Criteria:

1. Symptomatic cardial infarction
2. Decompensated cardiac insufficiency
3. Hemodynamically effective cardiac arrhythmias
4. Hemodynamically significant Vitia (heart disease)
5. Insufficiently regulated arterial hypertension
6. Global respiratory insufficiency
7. Significant partial insufficiency (PAO2 \<50mmHg or SaO2 \< 80% at rest)
8. State after decompensation of Cor Pulmonale
9. Right ventricular strain at pulmonary hypertension at rest (pulmonary arterial pressure \> 20 mmHg)
10. Severe osteoporosis
11. Higher degree of lung functional restriction: FEV1 \<50% oder \>60% of nominal value after bronchospasmolysis
12. Working performance on ergometer \< 50%
13. Unstable bronchial asthma
14. Exacerbated COPD
15. Heavily overweight (BMI \>40 or weight \>140kg)

Primary outcomes:
measure: Training time
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hagen
country: Germany
facility: Helios Klinik Hagen Ambrock
state: NRW
Study officials:
affiliation: Institut für Pneumologie Hagen Ambrock eV
name: Karl Heinz Ruehle, Prof
role: PRINCIPAL_INVESTIGATOR
References: